A Stepwise Strategy Utilizing Buprenorphine and Methadone

Condition(s) targeted: Heroin Dependence

Intervention: methadone (Drug); buprenorphine / methadone sequence (Drug); Relapse prevention (Behavioral); Contingency management (Behavioral)

Phase: Phase 4

Status: Completed

Sponsored by: Karolinska University Hospital

Official(s) and/or principal investigator(s):
Markus Heilig, MD PhD, Principal Investigator, Affiliation: Karolinska Institute, Stockholm

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.

Official title: Graded Strategy for Pharmacological Treatment of Heroin Dependence

Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Retention in treatment

Secondary outcome:

Proportion urine samples free of illicit drugs

Problem severity as measured by Addiction Severity Index

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.

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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.

Dept of Clinical Neuroscience, Karolinska Inst, Stockholm 14176, Sweden

Starting date: August 2005
Ending date: March 2006
Last updated: October 23, 2006