South African Guidelines for the Management of Opioid Dependence:



Lize Weich, Charles Perkel, Nicolette van Zyl, Prof Rataemane, Lochan Naidoo



Heroin is the main illicit opioid abused in South Africa. Between 8 and 21% of all patients who presented for treatment of substance dependency in the first half of 2006 stated that heroin was their primary or secondary drug of choice. These numbers are increasing, and include all racial groups. In Cape Town and Gauteng more heroin abusers are repeat treatment seekers compared to abusers of other substances. This underlines the relapsing nature of heroin abuse and dependence. Due to the current purity of available heroin in South Africa, smoking and sniffing it can give a high that is equal to that of injection use. There is a misconception that smoking or sniffing heroin is less addictive than injection use; the majority of heroin dependent treatment seekers are smoking it. Many adolescents become heroin dependent in this way.


The use of heroin in combination with other drugs is also on the rise. It includes “nyaope” and “pinch” (a mixture of cheap heroin and Cannabis) and “sugars” (a mixture of heroin and cocaine).


4 to 12% of treatment seekers in addiction treatment facilities are there because of over-the-counter or prescription medication abuse as their primary or secondary drug of choice; these medications include codeine and dextropropoxyphene containing analgesics and cough mixtures. This is also a significant group of opioid abusers with concerning morbidity in part because of the toxicity of other ingredients, which include paracetamol. 1


What is opioid dependence?:

Opioid dependence is a chronic relapsing disease that develops from repeated self-administration of opioids, including heroin, over-the-counter and prescription opioids. Genetic and environmental factors contribute to the development of this disease. 2,3,4  Repeated exposure to opioids can cause enduring structural and functional brain changes that are associated with distinctive behavioural patterns including compulsive substance seeking and repeated chronic use despite horrendous consequences 5.


Opioid dependence is associated with substantial morbidity and mortality (heroin dependence is associated with a mortality rate of about 1-2 % per year) and frequently requires long-term treatment (similar to many other chronic illnesses). It is however encouraging that, the proportion of clients who sustain abstinence, increase with time and the proportion still addicted decline. (22% of a cohort of 86 heroin dependent clients, followed up for 33 years, had died and death was mostly substance related; 42% of the cohort was abstinent from all opioids and had been for at least 10 years 6.) 


What is an opioid?

‘Opiate’ refers to derivatives of opium (such as morphine and diacetylmorphine or ‘heroin’). ‘Opioid’ refers to all substances natural and synthetic (such as pethidine) that act on the Mu-opioid receptors in the brain. Routine drug screens test positive only for opiates and special testing is required for synthetic opioids.


Abuse vs. dependence:

It is important to distinguish between opioid abuse and dependence, because different interventions are required.


Substance abuse implies that someone either persistently or sporadically uses substances in an unacceptable manner. This term is defined by DSM-IV 6 as a maladaptive pattern of substance use that leads to impairment or distress and manifests itself by any of the following: the user fails to fulfil important obligations at work, school or home; or uses substances in a manner that is physically hazardous; or has legal, social or interpersonal problems due to or exacerbated by the substance.


Dependence on the other hand, draws on both the physical and psycho-behavioural aspects of addiction and is used by both the ICD-10 7 and DSM-IV 8 classification systems. Three symptom/ sign domains are recognised by both these classification systems, namely:

·        physical adaptation of the body to the substance (tolerance; withdrawal),

·        loss of control over taking of the substance (strong desire or sense of compulsion to take the drug; difficulties in controlling substance taking behaviour; a desire or unsuccessful efforts to cut down or control use),

·        and salience: the substance takes over the person’s life (a great deal of time is spent obtaining or using the drug or recovering from its effects; progressive neglect of alternative pleasures and interests, or important activities and continued use despite clear evidence that it is harmful).

These three symptom domains need not all be present for dependence to be diagnosed.


Abuse can generally be managed adequately using a psycho-educational approach (e.g. brief interventions 9, motivational interviewing 10, 11). This document deals with the management of opioid dependence.


Medical model of the treatment for opioid dependence:

The ultimate aim of treatment for opioid dependence is total abstinence from all opioids. In clinical practice, the short-term success rate for total opioid abstinence is low, even following inpatient treatment. (In a 3-month follow up of 242 opioid-dependent patients in residential treatment in the National Treatment Outcome Research Study 12, 34% of the patients relapsed to heroin use within 3 days, 45% within 7 days, 50% within 14 days, and 60% within 90 days.)


Total abstinence does however remain an achievable goal for some patients. Smyth et al 13 looked at the outcome of 149 patients, following a 6-week residential program and aftercare program, and found a total abstinent rate of 23% after 2-3 years. Abstinence was significantly associated with program completion and attendance of aftercare. (57% were on maintenance treatment and 3% had died.)


Over time, most users eventually achieve remission 12. International trends in managing patients with opioid dependence have moved away from only focussing on total opioid abstinence towards including strategies aimed at harm reduction (keeping patients alive until they eventually go into remission) and abstinence from illicit opioids. Such strategies may involve the use of long-term oral substitute opioids until the addict is ready to change behaviour and maintain sobriety. This is termed opioid substitution therapy, and the 2 opioids used for this are methadone and buprenorphine.


We can thus conceptualise the medical management of opioid dependence as involving 2 potential options:


·        Achieving total abstinence rapidly using standard rapid detoxification procedures (rapid withdrawal over 7-21 days), followed by relapse prevention strategies.


·        Transferring the addict from abused opioids onto an individualised dose of substitution opioid (thus markedly reducing or preventing illicit drug use, allowing patients to stabilize their lifestyle), and slowly detoxifying them when they are ready.


The shift towards harm reduction is not yet widely accepted in South Africa. There is limited infrastructure and currently no legislation to accommodate opioid substitution therapy. It is important that South Africa develop the capacity to provide substitution prescription in a safe and controlled manner.


  1. Rapid detoxification from all opioids and relapse prevention:

Assisting opioid dependent individuals to achieve the goal of abstinence from all opioids rapidly involves different aspects:

·        Identification and motivation

·        Detoxification

·        Management of comorbid medical and mental health problems

·        Relapse prevention


Identification and motivation

Early identification of opioid dependent individuals is important. These problems evoke shame, denial, and defensiveness in the addict, and negative responses in health care workers. Social workers, educators, workers in the legal and judicial system, healthcare workers, and other persons who may be involved with these individuals should be educated to recognise signs of opioid use disorders. Healthcare workers need to learn skills in dealing with resistance and motivating opioid abusers to engage in treatment services (e.g. brief interventions 7, motivational interviewing 8,9)  and should be familiar with referral pathways and resources in their area.


Adequate services for assessment and motivation of clients should be available.


The Prevention and Treatment of Substance Dependency Act (1992) and the draft copies of this Act that are currently being revised, provides for the compulsory treatment of clients who are not motivated and who refuse treatment of their substance dependence and who are causing harm to themselves or their families. (“Committal” under Article 21/22 of the Prevention and Treatment of Substance Dependency Act (1992))


Management of comorbid medical and mental health problems:

Heroin dependence is associated with a high incidence of comorbid medical and mental health complications, which may require separate identification and treatment. Fatal overdose is a tragic complication, and heroin is the drug most implicated in fatal accidental poisonings. Other medical complications arise from non-sterile injecting practices or needle sharing, and include skin or systemic infections, HIV or Hepatitis B or C transmission, and complications because of adulterants, which can include talcum pneumonitis, and renal complications.  Common psychiatric problems include depression, protracted anhedonia (even with long-term abstinence), and personality disorders. Psychosis is rare but may arise from poly-substance abuse.



Detoxification is the first step of treatment, which then allows the addict to engage in the second and most important step of treatment, namely relapse prevention. It involves a graded and controlled reduction in tolerance to opioids, minimising unpleasant withdrawal symptoms. Two medication groups are used, often in conjunction: opioid substitution medication and symptomatic medication.


Substitution detoxification involves the use of a medication that acts at the opioid receptor, either a full agonist or a partial agonist, which is prescribed at a dose that alleviates withdrawal symptoms without causing intoxication (the ‘baseline dose’). The baseline dose is established in the 1st 3 days and then is gradually reduced usually over a period of 1-3 weeks, allowing the level of tolerance to normalise in a manner that is tolerable for the addict.


Symptomatic medications alleviate some of the withdrawal symptoms but not the dysphoria or the physical pain, and are used alone for mild withdrawal only.


Substitution detoxification options available in South Africa:

Full agonist

·        Methadone 13 (only available as Physeptone ® syrup (2 mg/5 ml) in South Africa; opioid detoxification is an off-label use)

·        Other – including codeine, Morphine-SR, and the atypical opioid, Tramadol (none of these medications are registered for detoxification, nor are they widely researched or accepted as medication of choice for detoxification)

Partial agonist

·        Buprenorphine 14

Non- substitution detoxification

·        Alpha-2 agonist e.g. clonidine 15

·        Other symptomatic medications

(See appendix B for suggested guidelines for detoxification)


Relapse prevention:

Once the addict is detoxified, the crucial issue is that of prevention of relapse back to opioids. This involves psychosocial rehabilitation and pharmacological interventions. Various psychosocial interventions are available that provide individuals in recovery with skills to maintain sobriety including cognitive behavioural therapy, relapse prevention therapy, motivational enhancement therapy, the spiritual 12-step programs and addressing social needs, like housing, employment and family reintegration.


There are limited pharmacological interventions available. Naltrexone is an opioid antagonist that blocks opioid receptors without producing an effect. This makes it difficult to get high. It has been used as an oral treatment, a depot monthly injection or as a longer-term implant formulation. There is not a lot of evidence for routine use of Naltrexone 16, but it may be very valuable in selected motivated patients 17. Compliance problems with oral Naltrexone can be overcome by using the depot formulation or implant 18. Naltrexone is unfortunately not registered in South Africa any more, but can be prescribed with MCC approval per patient and can then be ordered from overseas (e.g. using an online pharmacy).

(See appendix B for suggested guidelines on Naltrexone use)


Opioid dependence is a chronic relapsing disorder and relapse is common. Relapse can be used as a learning and growth opportunity. Many clients find that engaging in an aftercare program (for example a self-help support group like Narcotics Anonymous), provide them with a useful support structure and may reduce relapse. 


  1. Substitute opioid prescribing:

Some addicts are unable to give up their opioids, and interventions to reduce harm should be considered until such time that they are able to achieve total abstinence.


Given the chronic relapsing nature of opioid dependence and the frequently poor results of rapid detoxification and relapse prevention, reduction of drug-related harm has become the most important treatment modality in many countries. Although this strategy is not widely used and accepted in South Africa, substitution prescription of opioids is a well-established treatment option internationally. It is supported by a large body of research literature and clinical practice 19, 20. Cochrane reviews confirm that maintenance treatment with methadone 21 and buprenorphine 22 have proven effectiveness, provided that adequate dosages are prescribed and appropriate supervision is given.


Substitution is suitable for addicts who want to stop illicit opioid use, but who are unable to achieve abstinence from all opioids at that time. They receive a prescribed dose of methadone or buprenorphine at suitable doses to suppress withdrawal and craving, and in the case of buprenorphine, to block the ‘high’ if illicit opioids are used on top. This provides the person the opportunity to stabilise their life-style, develop insight and reduce harm from illicit drug use.


Methadone maintenance treatment has been shown to reduce morbidity 23, 24 (including HIV risk 25, incarceration 26, and other substance use 27) and mortality 28 associated with heroin dependence and improves treatment retention 23. When compared to detoxification and psychosocial interventions, methadone maintenance treatment has been shown have a better outcome 29. There is evidence that the same is true for buprenorphine 30.


The only formulation of methadone currently available in South Africa is Physeptone syrup ®, at a concentration of 2 mg/5 ml. This is a sweetened cough syrup, which has a high sugar content (prescribers should be aware of potential dental and other health implications) and high viscosity (makes accurate dispensing more difficult). Methadone is not currently registered for the management of opioid dependence in South Africa (substitution prescribing is thus an off-label use). Methadone generally has good oral bioavailability and its long half-life allows for daily oral dosing. Buprenorphine is available as a sublingual 2mg or 8mg tablet and its long half-life allows for once daily or even alternate day supervised consumption. Because it is a partial-agonist, with increasing dose the active effects plateau, making it safer and less likely to result in accidental overdose than full agonists like methadone. Individuals also report a 'clearer head' with buprenorphine, in contrast to the mental 'clouding' sometimes experienced with methadone. The choice of substitution drug rests with the prescribing physician. A higher level of tolerance, patient preference and contra-indications to use buprenorphine may be indications for choosing methadone. Ideally, the sugar-free 5 mg/5 ml elixir (not currently available in South Africa) should be used for substitution prescribing rather than the cough syrup. (See appendix B for suggested guidelines for buprenorphine and methadone substitution prescribing)


Substitution prescription does pose problems if unregulated, and these include the potential for unsafe or unethical practices by medical professionals. It is thus important that accreditation, guidelines and proper legislation be put into place to ensure that doctors who do substitution prescribing are properly trained and regulated in order to ensure patient safety. It is recommended that accredited prescribers only (medical practitioners who have attended an accredited training course in the management of opioid dependence) provide substitution treatment. It is suggested that a body of experts act as an interim accreditation committee until such time that this function can be taken over by a Professional Body of Addiction Practitioners.


Important elements of substitution prescribing include regular monitoring of patients, random drug screening to pick up relapse to illicit opioids and use of other addictive substances, and ongoing psychosocial interventions.


It is suggested that a remuneration package be negotiated for substitution prescribing with funders. Although over-servicing of patients should be avoided, flexibility is important. Some clients (especially those with co-morbid medical or mental health problems) may require more support, drug testing and supervision and the average number of doctor’s visits is likely to be higher in cases where no practice nurse or counsellors are available. 


Diversion of medication to the black market remains a valid concern and adequate supervision of patients with regard to opioid dispensing and consumption is essential. (See appendix C.)  A patient register would help to prevent “doctor-hopping”, but does not seem to be a feasible option at present.  It may be considered in the future.


The ultimate aim of opioid substitution treatment is eventual dose reduction and abstinence when the individual is ready, and treatment goals should be reviewed every 3-6 months.  Some argue that a small number of addicts require life-long substitution therapy due to a relative endogenous opioid deficiency. Better results are obtained when opioid substitution is continued for at least one year before attempts are made to reduce dose.



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Appendix A:


1. Signs and symptoms of opioid intoxication

2. Signs and symptoms of opioid withdrawal

3. Assessment of the opioid addict



1. Signs and symptoms of opioid intoxication

·        Euphoria, profound relief from anxiety and tension, followed by apathy

·        Initial mild brief increased energy, followed by psychomotor retardation

·        “nodding”- state between arousal and sleep, where individual is rousable

·        Pupillary constriction

·        Hypoactive bowels, constipation

·        Slow regular respiration, ň coughing, risk of respiratory depression

·        Slurred speech

·        ň judgement, concentration, memory

·        dulling of pain

·        difficult passing urine

·        nausea and vomiting

·        Sweating, warm flushing of the skin, itching

·        dry mouth

·        rarely convulsions

·        Large doses of heroin may result in a potentially lethal overdose


Various rating scales are available to estimate the severity of withdrawal. They are useful to ensure that the individual is in withdrawal prior to prescribing substitution medication, and to monitor progress. (See rating scales below, Appendix D)


2. Signs and symptoms of opioid withdrawal

 SYMPTOMS                                             SIGNS

Looks like a ‘flu-like’ illness

Abdominal cramps                                    Diarrhoea

Anxiety                                                    Increased blood pressure

Craving                                                    Increased pulse

Irritability, dysphoria                                 Lacrimation

Fatigue                                                    Muscle spasms

Hot and cold flushes                                  dilated pupils

Muscle aches                                            Pilo-erection

Nausea, sweating                                      Rhinorrhoea

Restlessness                                             Vomiting


The onset and duration of withdrawal depends on the half-life of the abused opioid.


Rough estimates of first appearance of withdrawal, peak and duration of withdrawal:


Time to withdrawal




4 – 6 hours

8 – 12 hours



6 – 12 hours

36 – 72 hours

5-10 days


8 – 20 hours




24 hours




36 – 72 hours

72 – 96 hours

up to 3 weeks


Methadone abstinence syndrome develops more slowly and is more prolonged but usually less intense than other opiate abstinence syndromes. These are average times only. In practice, it may take longer or shorter for withdrawal to start, peak or subside. Treat the withdrawal symptoms rather than the drug history.


3. Assessment of the opioid addict:

·        Every patient who requires an intervention for opioid dependence needs to have a detailed assessment, to identify complications and formulate treatment goals.

·         Enquire about what precipitated the consultation and the person's expectations.

·         Take a history to determine:

o        Opioids used: quantity, frequency, route, duration of current episode

o        The other substances used, including route, dosage, duration of use

o        Degree of dependence

o        Medical history, including diseases from drug use, other conditions,  current medications

o        Psychiatric history

o        Risk behaviour, Hepatitis A, B or C, and HIV status - if known

o        Forensic history, legal status

o        Social history – including employment, housing, financial, family

o        Previous treatment episodes/ rehabilitation centres attended, periods of abstinence

o        What precipitated the relapse (if relapsed)

o        Trigger for treatment, motivation to stop or change pattern of use

·         Examine for:

o        Evidence of drug use (e.g. needle tracks, signs of drug intoxication or withdrawal)

o        The presence of complications (e.g. poor nutrition, anaemia, skin abscess, thrombophlebitis, liver disease, HIV, chest infection, tuberculosis etc.)

·         Assess mental health and refer to a Psychiatrist if indicated

·         Discuss harm reduction:

o        Discuss safer sex

o        Risk of accidental overdose

o        Risk of blood-borne infections

o        Offer testing for infections i.e. hepatitis A, B, C and HIV (informed consent)

o        Offer hepatitis B vaccine

·         Do a urine or saliva drug test -results should be interpreted in the light of clinical findings, as false negatives and false positives can occur.

o        False positives can be caused by the use of loperamide, quinolones and over-the-counter medicines that contain codeine.

o        Negative results occur in people on synthetic opioids or may occur during pregnancy.

o        A negative result brings current dependence into doubt.

o        Repeat the urine test, as false negatives do occur.

§         On-site urine-testing strips provide a basic non-quantitative guide to the class of drugs currently used. If the test is positive and the person has obvious signs of opioid use (e.g. track marks, signs of withdrawal), it may be used as a confirmatory test for opioid use.

§         Mouth swab tests: Mouth swab tests (oral mucosal transudate) provide information about recent drug use, but there is a shorter detection window (when heroin has been taken, it can be detected up to 4 days later with urine tests but only up to 24-48 hours later with mouth swabs).

§         Urinalysis carried out in a laboratory is the most reliable confirmatory test and if there is any doubt about a result, it should be used. It is usually done by gas chromatography and although accurate, has the disadvantages of being more costly and takes longer before receiving a result.

·         Consider investigations to exclude complications. Choice of investigations is guided by clinical judgement, and may include:

o        Full blood count (to exclude anaemia, signs of infection)

o        Liver function tests (hepatitis or high intake of alcohol may cause abnormalities)

o        Electrolytes (to assess renal function)

o        Tests for hepatitis A, B, or C and HIV (pre-test and port test counselling required)

·         Is there convincing evidence of dependence? (Is the person taking drugs regularly? - daily use is an indicator of dependence)

·         Discuss the treatment options and agree on treatment goals and a management/treatment plan/programme

o        Detoxification and relapse prevention

o        Substitution therapy if appropriate


Appendix B:


1.  Guidelines for short detoxification from all opioids

          (i) Using Methadone (inpatient treatment recommended)

          (ii) Using Buprenorphine

                   Inpatient detoxification

                   Outpatient detoxification

          (iii) Using Clonidine

          (iv) Using symptomatic treatment

2.  Guidelines for the use of Naltrexone

3.  Guidelines for substitution prescribing

(i) Using buprenorphine

(ii) Using Methadone

4. Guidelines for transferring a patient from methadone to buprenorphine



1. Suggested short detoxification guidelines, with rapid total abstinence from all opioids:

·         Complete detailed assessment (see appendix A)

·         Outpatient detoxification should only be considered in selected cases where it is considered safe to do so (considering the risk of overdose and death). Other factors to consider include transport, level of motivation and social support. An infrastructure for daily supervised consumption of methadone or buprenorphine and regular follow-up and monitoring and random drug testing is required for outpatient detoxification. High levels of opioid tolerance, poly-drug use, and other co-morbidities indicate the need for inpatient detoxification.

·         Inpatient detoxification is particularly appropriate during pregnancy. Long-term supervised care is important during pregnancy and substitute prescribing may be appropriate.

·         Negotiate a treatment contract with the patient.

·         Patients should be educated that their level of tolerance is reduced during detoxification. The dose of illicit opioid that was used prior to detoxification may subsequently cause overdose.


1(i): Methadone:

·         Patients should present in early withdrawal – i.e. roughly 8-12 hours after last use

·         The baseline dose of methadone is determined by giving the patient small incremental doses of methadone until a dose is determined that alleviates signs of withdrawal without causing signs of intoxication. Once stabilised on this dose, it can then be gradually reduced.


Outpatient regime:

Outpatient methadone detoxification involves a risk of accidental overdose and thus requires skill and expertise. It is recommended that outpatient methadone detoxification is only used by doctors who have received appropriate training to ensure it is done safely. If used correctly, buprenorphine may be a safer choice.



Inpatient regime:

Day 1:

·                    VERY IMPORTANT: Ensure the patient is in withdrawal because of risk of overdose (if you are unsure, you can use a rating scale to ensure withdrawal, see below)

·                    Give Methadone 10 mg (=25 ml syrup) orally (supervise consumption) and watch for signs of intoxication (especially pinpoint pupils or drowsiness)

·                    If after 2 hours withdrawal symptoms are still present, give another 5-10 mg (12-25 ml syrup) orally

·                    Wait another 2 hours, if still symptomatic, repeat 5-10 mg for the last time

·                    Initial dose to suppress withdrawal symptoms can be repeated after 12 hours if symptoms re-emerge

Day 2 onwards until baseline dose is determined:

·                    Repeat total dose of day 1 as a single or divided doses (usually a twice daily dose)

·                    Watch for objective signs for withdrawal. If present, the daily dose may be increased by 5-10 mg. Watch for signs of intoxication

·                    This can be repeated daily (2-3 days) until the dose is determined that prevents symptoms of opiate abstinence syndrome

·                    The dose prescribed the previous day is then the baseline dose

From baseline dose onwards:

·                    Decrease by 10-20% of baseline dose daily or alternate days

·                    If patient’s withdrawal symptoms allow it, the withdrawal regime may be shortened

·                    Use non-substitute medication (see below) for any additional symptoms.


1(ii): Buprenorphine:

·        Buprenorphine dissociates slowly from the µ- opioid receptors giving it a long period of action. This helps to reduce withdrawal symptoms during dose reduction and blocks the effects of other opioids.

·        Buprenorphine is a safer alternative than other substitution drugs, but should not be used unsupervised with other sedative drugs, especially benzodiazepines, alcohol and other opioid drugs, as this can result in a potential overdose. Always warn patients about this risk.

·        It is recommended that consumption be supervised daily. (See appendix C)


Outpatient withdrawal:

Australian department of health recommend regime for short outpatient withdrawal

(Patients should be reviewed medically on a daily basis)


Proposed regime

Recommended lower and upper limits

Day 1

6 mg

4-8 mg

Day 2

8 mg

4-12 mg

Day 3

10 mg

4-16 mg

Day 4

8 mg

2-12 mg

Day 5

4 mg

0-8 mg

Day 6


0-4 mg

Day 7


0-2 mg

Day 8


0-1 mg


Total : 36 mg



Inpatient withdrawal:

Australian department of health recommend regime for inpatient withdrawal


Proposed regime

Total daily dose

Day 1

4 mg at onset of withdrawal and 2-4 mg evening dose PRN.

4-8 mg

Day 2

4 mg mane, 2-4 mg nocte PRN.

4-8 mg

Day 3

4 mg mane, 2 mg nocte PRN

4- 6 mg

Day 4

2 mg mane, 2 mg nocte PRN

2-4 mg

Day 5

2 mg PRN

0-2 mg

Day 6

No dose


Day 7

No dose




Total proposed dose 12-28 mg


Both these regimes are only rough guidelines. Some patients may require lower doses of medication. With high levels of tolerance, some patients require higher doses of buprenorphine (up to 16 mg /day). 



 Non-substitute medication for detoxification:   

·        Non-substitute prescribing is indicated in patients who choose a non-opioid withdrawal regime or who only experience mild withdrawal symptoms

·        Non-substitute, symptom relieving medications can be used in conjunction with substitution medications in order to reduce the daily opioid requirements


1(iii): Clonidine:

Clonidine (Dixarit®) is a medication marketed for the treatment of hypertension used for many years to treat the sympathetic hyperarousal that occurs in opioid withdrawal. It is most effective when used for detoxification in an inpatient setting because of potential side-effects.


Advantages include:

·        It is not a scheduled medication

·         The use of opioids can be discontinued immediately

·         It does not produce opioid euphoria and is not addictive


Although Clonidine alleviates some symptoms of opioid withdrawal, it is not effective for muscle aches, insomnia or drug craving. These symptoms require additional medication (see symptomatic medication below).


·        Ensure patient does not have blood pressure or cardiac abnormalities

·        Give a test dose of 50 micrograms orally or sublingually (75 micrograms may be used for patients weighing more than 80 kg)

·        Measure the patient's blood pressure after 30 minutes. If diastolic blood pressure is normal and there is orthostatic hypotension (a drop in systolic blood pressure of 10 mmHg upon standing), the patient may continue the regime

·        Clonidine 75-150 micrograms orally 6 hourly may be used

·        Taper this dose over 4-6 days


1(iv): Other symptomatic treatment:

·        Heroin withdrawal is highly uncomfortable, but it is not dangerous (except in physically compromised patients and during pregnancy). It is associated with various physical complaints and these can be treated symptomatically, providing they are not severe. Symptomatic treatment can also be used as an adjunct to substitute prescribing or Clonidine.


Examples include:

·        An antispasmodic like hyoscine butylbromide (Buscopan®) for the abdominal cramps

·        a non-steroidal anti-inflammatory drug like ibuprofen (Brufen®) for the muscle cramps and aches

·        Paracetamol for headaches

·        Diphenoxylate (Lomotil®) for diarrhea

·        Antacid for indigestion

·        Diazepam (Valium®), Oxazepam (Serepax®) or hydroxyzine (Aterax®) for cramps, irritability, dysphoria and anxiety (Important: Benzodiazepines should be used with great care in opioid dependence because of the risks of overdose with opioids and partial opioid agonists as well as the risk of comorbid abuse and dependence)

·        Temazepam, nitrazepam, hydroxyzine (Aterax®), Promethazine (Phenergan®), Trazadone 50-100mg  or Zopicone for insomnia

·        Prochlorperazine (Stemetil®) / Metochlopramide (maxalon®) for nausea and vomiting

·        Loperamide (Imodium®) for diarrhea

·        Octreotide (Sandostatin®) for withdrawal-induced nausea and diarrhea (off-label use)

·        Non-medications: hot/cold packs, relaxation, baths, massages, rubbing ointments, music, acupuncture, aromatherapy etc.


2. Suggested guidelines for the use of Naltrexone:

(Not currently registered in South Africa)


Naltrexone can be used as an aid to relapse prevention for individuals who have successfully detoxified from heroin and other opioids. This is termed Naltrexone maintenance or Antagonist-Assisted-Abstinence. Naltrexone works best in maintenance therapy if a nominated responsible carer is identified to supervise consumption (family/friend/GP/outpatient clinic). It is recommended that Naltrexone be prescribed by doctors experienced in treating substance disorders. Naltrexone is not registered in South Africa anymore and each patient needs MCC approval before it may be prescribed. Medication can be obtained from abroad (e.g. via an online pharmacy).

Naltrexone could be considered if:

·        The patient is completely opioid free for 5-10 days. This period can be shortened to as little as 72 hours in selected cases. This applies specifically to outpatients who cannot manage a week of being “clean” on their own.

·        The patient is willing to take a naltrexone.

·        The patient does not have severe or active liver or renal problems (typical guidelines suggest liver function tests no greater than 3 times the upper limits of normal and normal bilirubin).

·        The patient is not allergic to naltrexone.


Before taking the first tablet, request the following:

1.     Supervised urine test.

2.     Give a Naloxone challenge of 0,4 mg/ml SC. If signs or symptoms of withdrawal appear, the test is positive and no additional naloxone should be administered, and naltrexone should be delayed. If there are no signs or symptoms of withdrawal within 30 minutes, naltrexone tablets can be started.


Treatment regime for oral Naltrexone (Rivia®):

A maintenance dose of 50 mg (1 tablet) naltrexone daily produces an adequate block to all opioids. It is recommended that patients get into ‘a tablet a day’ routine, to prevent skipping or forgetting doses, though the following regimes are acceptable:

1.     50 mg daily Monday to Friday, 100 mg on Saturday

2.     100 mg every other day

3.     150 mg every third day

4.     100 mg on Monday & Wednesday & 150 mg on Friday

5.     150 mg Monday & 200 mg on Thursday



Naltrexone Implants

Naltrexone implants are currently only available under Section 21 Approval from the MCC. Individual applications are assessed and approved if deemed appropriate. Reasons for an implant include the desire to remain abstinent but inability to do so even after several inpatient rehabilitation admissions, and patients who have poor compliance to naltrexone tablets and no one to supervise administration of the tablets.


Length of treatment

In general, patients need a treatment period of at least 6 months to make the behavioural changes necessary to remain abstinent, but for many this process can take up to 2 years. Some patients may require it only during the initial transitional phase for a brief period. Some patients may require it only during periods of crisis.



1.     Accidental overdose when Naltrexone is stopped and clients relapse to illicit opioids because of reduced tolerance levels.

2.     Precipitation of severe opioid withdrawal symptoms (including seizures).


Other uses of naltrexone

Naltrexone is sometimes used to treat alcohol dependence as it appears to decrease the desire to drink in some people. It does not block the effects of alcohol unlike its ability to block heroin.


3. Suggested Guidelines for Substitution Prescribing:  


Aims of substitution prescribing:

·        Reduce or eliminate illicit opioid and other drug use

·        Improve the health and wellbeing of those in treatment

·        Facilitate psychosocial rehabilitation of those in treatment

·        Reduce the spread of blood-borne diseases associated with injecting drug use

·        Reduce the risk of death associated with opioid use

·        Reduce level of involvement in crime associated with opioid use



·         It is recommended that all prescribers be accredited (attend an accreditation course) in substitution prescribing, and that funders only fund such accredited practitioners.

·         Patients for substitution treatment should be carefully selected. Ideally, these patients should have had at least one failed attempt at standard detoxification and rehabilitation.

·         Patients need to have a diagnosis of opioid dependence and have evidence of physical dependence (tolerance, withdrawal).

·         Patients should be well motivated and give informed consent to substitution prescribing. 

·         Patients should ideally be 18 years or older. It is recommended that a specialist second opinion be obtained before starting youngsters younger than 18 years on substitution treatment.



·        Concomitant medical or mental health problems increase the complexity of management and may even increase risk of overdose and death.

·        High-risk poly-drug use, especially drugs that cause sedation like alcohol, anti-depressants or benzodiazepines.

·        Alcohol dependence – ensure if methadone liquid is used, that it does not contain alcohol, especially if concomitant disulfiram is used.

·        History of possible reduced tolerance (e.g. after a Naltrexone implant)

·        Individuals who are at risk of self-harm.


1.     Initial assessment: (See appendix A3 – “assessment of the opioid addict”)

·        Consider whether substitution therapy is appropriate. How does the person wish to change, and will substitution therapy encourage this?

·        Always perform a urine or saliva test to confirm opioid use. (Before initiating substitution therapy, it is usually best to ensure that at least one positive urine test for opioids was obtained).


  1. Initiating treatment and stabilization

·        Supervised consumption is required (at least initially, until the patient is stable and the prescribing doctor feels confident that the patient will comply) – see notes appendix C.

·        Drug testing: patients should be tested as often as indicated, at least weekly at first

o       Positive test: these individuals should be further evaluated. During the initiation and stabilization phase, illicit drug use may indicate an inadequate dose of substitution medication, and a dose increase should be considered. However, if the client remains disinterested and unmotivated to comply, substitution prescribing should be stopped.

·        Never increase the dose without a practitioner first seeing the person.

·        If possible, review the person daily during the first few days in order to titrate the dose against withdrawal symptoms, until the person is clinically stable on their substitution dose. If this is not possible, the person should be seen every 2-3 days and the dose increased only then.


  1. Maintenance phase

·        Supervised consumption, regular urine testing and weekly dispensing are required (at least initially). Care plans should be individualised. As a rough guide:

o       For 1st month: The person should come in for a urine/saliva drug test weekly and only be prescribed the next week’s supply if ‘clean’. Daily supervised consumption is advisable, especially initially; it may be decreased to alternate days and later weekly supervision when indicated. (Take-home doses can be used as a “reward” for good compliance; poor compliance or positive tests should be dealt with (without being punitive) and are indications for continued daily-supervised consumption).

o       For month 2 – 3: The person should come in for a urine/saliva drug test 2 weekly if stable, with the next 2 weeks supply prescribed if ‘clean’.

o       For month 3 – 6: The person should come in for a urine/saliva drug test every 4 weeks if stable, with the next 4 weeks supply prescribed if ‘clean’.

·        Erratic attendance should be confronted and dealt with (it usually indicates poor compliance). These patients may need to have a standard detoxification (see above) or may require inpatient treatment.

·        Any evidence of diversion of medication should lead to immediate termination of treatment. 

·        Missed doses:

o       If a person misses a daily dosage, it must not be replaced. The next dose should be taken at the usual time on the following day.

o       If the person misses 2 or 3 days in succession, the usual dose should be given providing there is no evidence of intoxication and the missed doses should not be replaced.  Confront poor compliance – it is most likely an indication of illicit drug use. If the person has used heroin in the intervening period, the dose may have to be re-titrated.       

o       If more than 3 consecutive days have been missed, tolerance will have been lost and therefore the dose should be re-titrated (see guidelines on initiating treatment).

·        A thorough review is indicated every 3 months and should include reassessing the treatment plan with respect to goals achieved and new goals aimed for.

·        Psychosocial interventions should be encouraged during treatment, which should include attempts at achieving greater life stability.


  1. Dose reduction and discontinuation of maintenance

·        Longer-term outcomes are enhanced by longer treatment periods (1-2 years) and dose reduction should only be attempted when the client is ready and motivated for this (e.g. has stable and supportive lifestyle).

·        Gradual reductions over weeks result in better outcomes than rapid reductions.

·        Patients may require more regular follow-up during the dose-reduction phase. Worsening in the patient’s feelings of wellbeing, or an increase in illicit drug use requires a temporary cessation or slowing down of the dose reduction.

·        Dose reductions should be made in consultation with the patient. Continued reductions in a distressed and uncomfortable patient are counter-productive.

·        Symptomatic medication (see above) may also be used during dose reduction.

·        Ongoing psychosocial support is necessary and structured aftercare reduce the risk of relapse and supportive care is advised for at least 6 months following cessation.


3 (i) Buprenorphine (Subutex®) substitution prescribing:


See general guidelines above.


1. Initial assessment:

·         Check liver function tests (LFTs) before starting buprenorphine substitution treatment. You may start treatment while waiting for the results, providing the patient is well.

o        In people who do not have liver disease, LFTs should be checked regularly, and some experts would advise at least every 6 months.

o        In people with mild alterations of LFTs, but who are well, monitor at least every 6 months (more frequently if clinically indicated) and monitor alcohol intake.

o        In people with symptomatic liver disease (e.g. hepatitis C positive, with alcohol misuse), seek specialist advice. LFTs need to be checked regularly: usually a minimum of every 2-3 months.

o        If there is evidence of a marked deterioration in LFTs, seek specialist advice.

o        Buprenorphine should never be started if the person has evidence of ascites or cirrhosis.


2. Initiating treatment and stabilization on buprenorphine

·         Withdrawal symptoms may be precipitated by the partial antagonist properties of buprenorphine. These typically occur 1-3 hours after the initial dose of buprenorphine. To avoid withdrawal when switching from heroin, delay the first dose of buprenorphine until at least 8 hours after the last dose of heroin and ensure there is clinical evidence of opioid withdrawal (a rating scale may be useful, see below).

·         If the person experiences severe precipitated withdrawal symptoms on switching to buprenorphine:

·         The usual recommended starting dose is 2- 4 mg. Most patients will require 4 mg. When starting buprenorphine, start low and titrate rapidly.

·         Rapidly titrate dose by 2-4 mg daily (usually 4 mg for severe withdrawal) according to clinical response over the next few days, up to a maximum of 16 mg. 


3. Maintenance phase with buprenorphine

·         The average daily maintenance substitution dose of buprenorphine is between 8 and 16 mg.

·         Buprenorphine should initially be prescribed for daily use; alternate-day dosing should not be considered until the person has been stable for at least 3 months. The effectiveness of alternate-day dosing may suit only 30-60% of people and should be considered only after consultation with an experienced prescriber. The dose should be titrated to clinical need, and the following is a guide only:


4. Dose reduction and discontinuation of maintenance buprenorphine:

·        Dose reductions are best negotiated with the patient.


Clinical drug interactions to be aware of:

·         Buprenorphine is extensively metabolized by the liver via the cytochrome P450 system, and blood levels can be affected by the concurrent use of drugs that either inhibit or induce liver enzymes.

·         Drugs that increase blood levels of buprenorphine include:

·         Drugs that decrease blood levels of  buprenorphine include:

·         Practitioners should be aware of these potential drug interactions. They are however rarely clinically significant.


3(ii) Methadone substitution prescribing


See general guidelines.


Note that the only formulation of methadone currently available in South Africa is Physeptone syrup®, at a concentration of 2 mg/5 ml. This is a sweetened cough syrup with a high sugar content and prescribers should be aware of potential dental and other health implications. The syrup’ high viscosity makes it difficult to accurately measure out (as opposed to the 5 mg/5 ml watery, sugar-free elixir used for substitution in other countries). Methadone is not currently registered for the management of opioid dependence in South Africa and substitution prescribing is thus an off-label use.


Contraindications for methadone substitution prescribing:

·        Severe liver impairment (methadone may precipitate hepatic encephalopathy)

·        Severe respiratory depression, acute asthma

·        Acute alcoholism

·        Head injury or raised intracranial pressure

·        Ulcerative colitis, biliary or renal tract spasm

·        Use of monoamine oxidase inhibitors or within 14 days of stopping this


1.  Initial assessment:

·        See general guidelines above

·        Methadone may increase the QT interval and this risk is increased with higher doses, concomitant use of a P450 3A4 inhibitor, hypokalemia and impaired hepatic function. ECG’s should be considered in these patients.


2. Initiating treatment

·        It is important to achieve a balance between adequate relief of withdrawal symptoms and avoidance of toxicity, sedation and even death.

·        Inadequate doses may lead to “topping up” with heroin, benzodiazepines or other opioids, with also potential lethal consequences.

·        The first dose of methadone should be determined for each patient based on the level of tolerance obtained through the history (including the quantity, route, frequency, money spent etc.). A definite period of observation for objective signs of withdrawal may also be helpful.

·        A dose of 20 mg for a 70 kg patient can be presumed safe. Extreme caution should be exercised for starting doses of 30 mg or higher.

·        Patients should be observed for 3-4 hours after the first dose for signs of toxicity or withdrawal.

·        If the patient experiences persistent withdrawal symptoms at 4 hours, a supplementary dose of 5 mg methadone may be considered.


3. Stabilisation on methadone

·        The aim of the stabilization phase is to determine a dose that allows the patient to stabilise without oscillating between intoxication and withdrawal.

·        The patient should be monitored daily for the first 2 weeks prior to dosing for signs of intoxication or withdrawal and preferable at least twice/ week by an experienced clinician.

·        Dose increases should only be considered subject to assessment by the prescriber.

·        The dose is titrated against the individual patient’s needs


 4. Maintenance phase

·        Maintenance doses are determined for individual patients, but generally a higher dose in required than during stabilisation phase

·        A slow and careful up-titration is required

·        Effective maintenance doses are typically 60- 100 mg.

·        At these doses, methadone ensures a substantial level of tolerance to the effects of illicit heroin in the majority of individuals.


5.                 Dose reduction and discontinuation of methadone:

·        Reduce dose by 10 mg/week to a level of 40 mg and then by 5 mg/week.

·        Negotiate each reduction with the patient and do not make changes more frequently than once per week.

·        Signs and symptoms of withdrawal will begin to rise as the methadone dose fall below 20 mg/day. Peak symptoms occur 2-3 days after cessation and may be slow to subside (up to 10-20 days).

·        Patients could be transferred on to buprenorhine with doses of 30 mg of lower.


From “Clinical guidelines and procedures for the Use of Methadone in the Maintenance Treatment of Opioid Dependence” Australian Government Drug Strategy, Aug 2003


4. Guidelines for transferring a patient from methadone to buprenorhine:


·        Reduce the dose of methadone as low as possible (preferable below 30 mg)

·        Cease methadone and commence buprenorphine > 24 hours after the last methadone dose –wait for objective signs of early withdrawal

·        The likelihood of precipitated withdrawal is reduced as the interval between last dose of methadone and first dose of buprenophine increases.


Last dose of methadone (mg)

First dose Buprenorphine (mg)

Day 2 dose of buprenorphine (mg)











·        Communication between prescriber, dispensing staff and client is important. Regular review, preferable daily for the first few days are advisable.

·        Clients may expect to feel uncomfortable for several days (up to 2 weeks) after transfer, and require frequent reviews.

·         Increase dose only after reviewing the clients and consider increments of 2-4 mg at a time if needed.

·        Alternate day dosing can be considered, once the client has been stable for 3 months as discussed under Appendix 3(i).

·        Follow guidelines for maintenance and discontinuation as discussed under Appendix 3(i).



Appendix C:


Information for prescribing opioid controlled drugs

Notes on supervised consumption



Information for prescribing opioid controlled drugs


Notes on supervised consumption:


Appendix D:


Rating scales for withdrawal symptoms:

1. Clinical Opiate Withdrawal scale

2. Clinical Institute Narcotic Assessment (CINA) Scale



1. Clinical Opiate Withdrawal Scale (COWS)

For each item, circle the number that best describes the patient's signs or symptoms. Rate just on the apparent relationship to opiate withdrawal. For example, if heart rate is increased because the patient was jogging just prior to assessment, the increased pulse rate would not add to the score.

Patient Name:



1. Resting pulse rate: ______ beats/minute Measured after the patient is sitting or lying for one minute.

0 Pulse rate 80 or below

1 Pulse rate 81 --100

2 Pulse rate 101 --120

4 Pulse rate greater than 120

7. GI upset: over last half hour

0 No GI symptoms

1 Stomach cramps

2 Nausea or loose stool

3 Vomiting or diarrhoea

5 Multiple episodes of diarrhoea or vomiting

2. Sweating: over past half hour not accounted for by room temperature of patient activity

0 No reports of chills or flushing

1 Subjective reports of chills or flushing

2 Flushed or observable moisture on face

3 Beads of sweat on brow or face

4 Sweat streaming off face

8. Tremor: observation of outstretched hands

0 No tremor

1 Tremor can be felt, but not observed

2 Slight tremor observable

4 Gross tremor or muscle twitching

3. Restlessness: observation during assessment

0 Able to sit still

1 Reports difficulty sitting still, but is able to do so

3 Frequent shifting or extraneous movements of legs/arms

5 Unable to sit still for more than a few seconds

9. Yawning: observation during assessment

0 No yawning

1 Yawning once or twice during assessment

2 Yawning three or more times during assessment

4 Yawning several times/minute

4. Pupil size

0 Pupils pinned or normal size for room light

1 Pupils possibly larger than normal for room light

2 Pupils moderately dilated

3 Pupils so dilated that only the rim of the iris is visible

10. Anxiety or irritability

0 None

1 Patient reports increasing irritability or anxiousness

2 Patient obviously irritable, anxious 4 Patient so irritable or anxious that participation in the assessment is difficult

5. Bone or joint aches: if patient was having pain previously, only the additional component attributed to opiate withdrawal is scored.

0 Not present

1 Mild diffuse discomfort

2 Patient reports severe diffuse aching of joints/muscles

4 Patient is rubbing joints or muscles and is unable to sit still because of discomfort

11. Gooseflesh skin

0 Skin is smooth

3 Piloerection of skin can be felt or hairs standing up on arms

5 Prominent piloerection

6. Runny nose or tearing: not accounted for by cold symptoms or allergies

0 Not present

1 Nasal stuffiness or unusually moist eyes

2 Nose running or tearing

4 Nose constantly running or tears streaming down cheeks

Total Score: _______________

[The total score is the sum of all 11 items.]

Initials of person completing assessment: _______________

Score: 5-12=Mild; 13-24=Moderate; 25-36=Moderately severe; >36=Severe withdrawal

Source: Adapted from Wesson et al. 1999.


2. The Clinical Institute Narcotic Assessment (CINA) Scale :

The Clinical Institute Narcotic Assessment (CINA) Scale for withdrawal symptoms measures 11 signs and symptoms commonly seen in patients during narcotic withdrawal. This can help to gauge the severity of the symptoms and to monitor changes in the clinical status over time.




Based on Questions and Observation:



(1) Abdominal changes: Do you have any pains in your abdomen?

No abdominal complaints; normal bowel sounds

Reports waves of crampy abdominal pain

Crampy abdominal pain; diarrhoea; active bowel sounds




(2) Changes in temperature: Do you feel hot or cold?

None reported

Reports feeling cold; hands cold and clammy to touch

Uncontrolled shivering




(3) Nausea and vomiting: Do you feel sick in your stomach? Have you vomited?

No nausea or vomiting

Mild nausea; no retching or vomiting

Intermittent nausea with dry heaves

Constant nausea; frequent dry heaves and/or vomiting





(4) Muscle aches: Do you have any muscle cramps?

No muscle aching reported; arm and neck muscles soft at rest

Mild muscle pains

Reports severe muscle pains; muscles in legs arms or neck in constant state of contraction




Based on Observation Alone:



(5) goose flesh

None visible

Occasional goose flesh but not elicited by touch; not permanent

Prominent goose flesh in waves and elicited by touch

Constant goose flesh over face and arms





(6) nasal congestion

No nasal congestion or sniffling

Frequent sniffling

Constant sniffling watery discharge




(7) restlessness

Normal activity

Somewhat more than normal activity; moves legs up and down; shifts position occasionally

Moderately fidgety and restless; shifting position frequently

Gross movement most of the time or constantly thrashes about






(8) tremor


Not visible but can be felt fingertip to fingertip Moderate with patient's arm extended

Severe even if arms not extended





(9) lacrimation


Eyes watering; tears at corners of eyes

Profuse tearing from eyes over face




(10) sweating

No sweat visible

Barely perceptible sweating; palms moist

Beads of sweat obvious on forehead

Drenching sweats over face and chest





(11) yawning


Frequent yawning

Constant uncontrolled yawning





[Sum of points for all 11 parameters]


Minimum score=0, Maximum score=31.

The higher the score, the more severe the withdrawal syndrome.

Percent of maximal withdrawal symptoms=((total score)/31) x 100%.

Source: Adapted from Peachey, J.E., and Lei, H. Assessment of opioid dependence with naloxone. British Journal of Addiction 83(2):193 --201, 1988.