A Stepwise Strategy Utilizing Buprenorphine and Methadone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-03-31

Brief Summary

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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

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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

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Heroin Dependence

Keywords

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heroin dependence methadone buprenorphine contingency management relapse prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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methadone

Intervention Type DRUG

buprenorphine / methadone sequence

Intervention Type DRUG

Relapse prevention

Intervention Type BEHAVIORAL

Contingency management

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Markus Heilig, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institute, Stockholm

Locations

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Dept of Clinical Neuroscience, Karolinska Inst

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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KarolinskaUH Regional 373/03

Identifier Type: -

Identifier Source: org_study_id