Rationale and evidence
Rationale
Informed consent and treatment decision-making can be complicated in the field of addiction medicine where at times 'desperate' patients and/or their carers are attracted to treatment approaches that may not be supported by available evidence. In considering treatment options, it is our responsibility to present patients and carers with the available evidence regarding safety and effectiveness and to clearly identify where a proposed medication is not licensed for an indication.
There are several medications in the field of addiction medicine for which the evidence is still emerging, such as the use of baclofen or topiramate in the treatment of alcohol dependence, amphetamine-based medications in the treatment of methamphetamine dependence, flumazenil for benzodiazepine withdrawal, or nabiximols in treating cannabis dependence. Other products (e.g. long acting naltrexone implants, medical cannabis products) may not be licensed by local regulatory bodies (the Therapeutic Goods Administration in Australia and Medicines Control in AoNZ).
In these circumstances, clinicians should a) follow RACP guidance regarding off-label prescribing or relevant therapeutic advisory bodies such as the Council of Australian Therapeutic Advisory Groups, the TGA and Medicines Control’s medicine safety updates and procedures for unlicensed medications, b) provide clear and written information to patients and carers and c) consider such treatment approaches as ‘second line’ options for those not responding to conventional treatment approaches. A second opinion from another Addiction Medicine specialist is often advised.
Note: Naltrexone implants are unlicensed in either Australia or overseas. They should not be confused with depots, which are licensed in the US and Europe.
Evidence
Baandrup L, Ebdrup BH, Rasmussen JØ, Lindschou J, Gluud C, Glenthøj BY. Pharmacological interventions for benzodiazepine discontinuation in chronic benzodiazepine users. Cochrane Database Syst Rev. 2018;3(3):CD01148.
Council of Australian Therapeutic Advisory Groups, Rethinking medicines decision-making in Australian Hospitals: Guiding Principles for the quality use of off-label medicines (PDF), 2013.
Minozzi S, Saulle R, Rösner S. Baclofen for alcohol use disorder. Cochrane Database of Systematic Reviews 2018, Issue 11. Art. No.: CD012557.
Nielsen S, Gowing L, Sabioni P, Le Foll B. Pharmacotherapies for cannabis dependence. Cochrane Database Syst Rev. 2019;1(1):CD008940. 2019 Jan 28.
Pani PP, Trogu E, Pacini M, Maremmani I. Anticonvulsants for alcohol dependence. Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.: CD008544.
Royal Australasian College of Physicians, Guidelines for ethical relationships between health professionals and industry. Sydney:, 2018 https://www.racp.edu.au/news-and-events/faqs/guidelines-for-ethical-relationships-between-physicians-and-industry.
Siefried KJ, Acheson LS, Lintzeris N, Ezard N. Pharmacological Treatment of Methamphetamine/Amphetamine Dependence: A Systematic Review. CNS Drugs. 2020 Mar 17. doi: 10.1007/s40263-020-00711-x. PMID: 32185696.