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

Phase 4

Completed

• Conditions: heroin addiction; Mental Health - Addiction

• Registration Number: ACTRN12609000138280
• Lead Sponsor: Hunter New England Area Health Service, Drug and Alcohol Clinical Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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.

Exclusion Criteria

Current pregnancy or breat feeding.
Children under 16 years at home with current Department of Community Services(DOCS) involvement.
Pending court hearings with a risk of custodial sentence.
Current DSMIV substance dependence to alcohol, benzodiazepines, amphetamines or cocaine.
Any Opiate Substitution Thearpy (OST) in the previous 4 weeks or more than 2 weeks consecutive OST in the previous 12 weeks.
Co-existing major medical or psychiatiric condistions where immediate OST and / or otehr treaments are warranted.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Baseline, end of one, two and three months.]

Secondary Outcome Measures

Name	Time	Method
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).[Baseline, end of one, two and three months];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.[Baseline, end of one, two and three months];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.[Baseline, end of one, two and three months]