Injectable versus oral opioid maintenance treatment for heroin addicts currently failing to benefit from standard treatment: a three way Randomised Controlled Trial (RCT) of injectable heroin versus injectable methadone versus oral methadone maintenance

Completed

• Conditions: Opiate dependence/addiction; Mental and Behavioural Disorders; Opioid dependence

• Registration Number: ISRCTN01338071
• Lead Sponsor: South London and Maudsley NHS Foundation Trust and Kings College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

The selection criteria targets heroin users with a long-standing history of injecting heroin use who continue to inject heroin frequently whilst in their current episode of methadone treatment. Selection criteria include:
1. History of injecting heroin use sufficient to meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
2. Aged between 18 and 65 years at recruitment to study
3. In continuous methadone treatment for at least 6 months this episode
4. Regular injecting heroin use

Exclusion Criteria

1. No active significant medical (e.g., hepatic failure) or psychiatric condition (active psychosis, severe affective state) as determined by study medical officer
2. Not alcohol dependent or abusing benzodiazepines according to DSM-IV revised criteria
3. Not pregnant, breast feeding, or planning to become pregnant during the study period
4. Able and willing to participate in the study procedures (e.g., no impending prison sentence) and provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified