A randomised controlled trial of unsupervised buprenorphine-naloxone versus wait list contol for heroin addiction

INTERVENTION: Patients randomised to the treatment group will receive daily buprenorphine naloxone for a period of 3 months administered as tablets of Suboxone delviered sublingually. During week 1 of dosing, the daily dose will be escalated from 4mg up to 16mg per day and tolerability to the dose will be determined, The maximum tolerable daily dose level will then be given for the duration of the treatment period. Dose tolerability will also be continually reviewed and doses modfied as required during this period. Half of the initial dose of Suboxone tablets on the first day of treatment will be delivered to the patient in the clinic. For the remainder of the treatment period patients will be supplied with enough Suboxone tablets to enable them to self administer their own daily doses for the following week. At the commencement of each week during the treatment period patients will return to the clinic and be reviewed and receive enough take home doses for the following week of treatment. CONDITION: heroin addiction PRIMARY OUTCOME: To determine if heroin users randomised to receive buprenorphine‐naloxone have a greater reduction in heroin use compared to patients on a waiting list for methadone or buprenorphine maintenance treatment. Heroin use will be determined by self report using the Opiate Treatment Index Questionnaire (OTI), urine analysis for drugs of abuse content and hair analysis (conducted at baseline and 3 months only) for drugs of abuse content. SECONDARY OUTCOME: Compare differences in Psychosocial functioning between the two groups. Pyschosocial functioning in all study participants will be determined using the Short Form 12 (SF12) interview‐style questionnaire. Psychological distress will be measured using the Kessler 10 (K10) questionnaire. Compare differences in the Quality of Life evaluation between the two groups. This will be assessed using the World Health Organisation Abbreviated Quality of Life Questionnaire (WHOQOL‐BREF). Compare the blood borne virus risk practices between the two groups using the Injecting and Sexual Practises domain of the Opiate Treatment Index (OTI) Questionnaire. INCLUSION CRITERIA: Diagnostic and Statistical manual of Mental Disorders, Fourth Edition (DSM IV) diagnosis of heroin dependence disorder. Recent heroin use (at least 20 days in the last month. Stable accomodation within the local geographical area. If female, willing to use contraception during the trial.