A Stepwise Strategy Utilizing Buprenorphine and Methadone

Heroin Dependence Clinical Trial

Official title:

Graded Strategy for Pharmacological Treatment of Heroin Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310934
• Other study ID #: KarolinskaUH Regional 373/03
• Status: Completed
• Phase: Phase 4
• First received: April 3, 2006
• Last updated: October 23, 2006
• Start date: August 2005
• Est. completion date: March 2006

Study information

• Verified date: March 2006
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heroin Dependence

Intervention

Drug:
• methadone

• buprenorphine / methadone sequence

Behavioral:
• Relapse prevention

• Contingency management

Locations

Country	Name	City	State
Sweden	Dept of Clinical Neuroscience, Karolinska Inst	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska University Hospital	Schering-Plough, Stockholm County Council, Sweden, Swedish National Drug Policy Coordinator

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in treatment
Secondary	Proportion urine samples free of illicit drugs
Secondary	Problem severity as measured by Addiction Severity Index