NCT00310934

A Stepwise Strategy Utilizing Buprenorphine and Methadone

Graded Strategy for Pharmacological Treatment of Heroin Dependence

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (planned)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heroin Dependence

Interventions

Type	Name	Description
DRUG	methadone
DRUG	buprenorphine / methadone sequence
BEHAVIORAL	Relapse prevention
BEHAVIORAL	Contingency management

Timeline

• Start date: 2005-08-01
• Completion: 2006-03-01
• First posted: 2006-04-05
• Last updated: 2006-10-24

Locations

1 site across 1 country: Sweden