A Stepwise Strategy Utilizing Buprenorphine and Methadone

Phase 4

Completed

• Conditions: Heroin Dependence

• Registration Number: NCT00310934
• Lead Sponsor: Karolinska University Hospital

Brief Summary

The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy, where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.

Detailed Description

The objective of this study is to compare optimally given methadone maintenance treatment (MMT) for heroin dependence with a novel, sequential strategy (STEP), where patients are offered buprenorphine as first line treatment, allowed dose adjustments as needed, and switched to methadone if the maximal dose of buprenorphine is insufficient.

For this purpose, 96 subjects at two centers (Uppsala and Stockholm) are randomized to MMT or STEP and followed for 6 months. Retention in treatment is the primary outcome. Secondary outcomes in completers are proportion urine samples free of illicit opiates on app. twice weekly sampling, and problem severity as measured by a semistructured interview, the Addiction Severity Index (ASI) at baseline and after 3 and 6 months.

Study Timeline

• Study Start: 2005-08
• Status Verified: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2006-04-03
• Study First Submitted QC: 2006-04-03
• Study First Posted: 2006-04-05
• Last Update Submitted: 2006-10-23
• Last Update Posted: 2006-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Heroin dependence according to DSM IV > 1year
• Age > 20 years
• Acceptance of the stated treatment principles.

Exclusion Criteria

• Severe psychiatric illness such as dementia or psychosis compromising the patient's ability to provide informed consent
• Other clinically significant psychiatric illness unless stable under treatment
• Severe medical condition such as advanced lung disease, unstable cardiovascular disease, severe liver disease
• Other clinically significant medical condition unless stable under treatment
• Treatment with anti-seizure drugs or disulfiram
• Pregnancy or intent to become pregnant within the next year
• Ongoing nursing
• Patients involuntarily discharged from a methadone or buprenorphine maintenance program within the last 3 months not eligible.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retention in treatment

Secondary Outcome Measures

Name	Time	Method
Proportion urine samples free of illicit drugs
Problem severity as measured by Addiction Severity Index

Trial Locations

Locations (1)

Dept of Clinical Neuroscience, Karolinska Inst; 🇸🇪 Stockholm, Sweden