A Stepwise Strategy Utilizing Buprenorphine and Methadone

Graded Strategy for Pharmacological Treatment of Heroin Dependence

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00310934

Enrollment

Registered

2006-04-05

Start date

2005-08-31

Completion date

2006-03-31

Last updated

2006-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heroin Dependence

Keywords

heroin dependence, methadone, buprenorphine, contingency management, relapse prevention

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 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.

Interventions

DRUGmethadone

DRUGbuprenorphine / methadone sequence

BEHAVIORALRelapse prevention

BEHAVIORALContingency management

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Retention in treatment	—

Secondary

Measure	Time frame
Proportion urine samples free of illicit drugs	—
Problem severity as measured by Addiction Severity Index	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026