Clinical Trial: A Stepwise Strategy Utilizing Buprenorphine and Methadone
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Graded Strategy for Pharmacological Treatment of Heroin Dependence
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 Summary:
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.
Sponsor: Karolinska University Hospital
Current Primary Outcome: Retention in treatment
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion urine samples free of illicit drugs
- Problem severity as measured by Addiction Severity Index
Original Secondary Outcome: Same as current
Information By: Karolinska University Hospital
Dates:
Date Received: April 3, 2006
Date Started: August 2005
Date Completion: March 2006
Last Updated: October 23, 2006
Last Verified: March 2006
