Overview

A Stepwise Strategy Utilizing Buprenorphine and Methadone

Status:
Completed
Trial end date:
2006-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Karolinska University Hospital
Collaborators:
Region Stockholm
Schering-Plough
Stockholm County Council, Sweden
Swedish National Drug Policy Coordinator
Treatments:
Buprenorphine
Methadone
Criteria
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.