A Stepwise Strategy Utilizing Buprenorphine and Methadone

Study Overview
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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.

Official Title
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Graded Strategy for Pharmacological Treatment of Heroin Dependence

Conditions
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Heroin Dependence

Intervention / Treatment
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* Drug: methadone
* Drug: buprenorphine / methadone sequence
* Behavioral: Relapse prevention
* Behavioral: Contingency management


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: methadone|nan|
|Drug: buprenorphine / methadone sequence|nan|
|Behavioral: Relapse prevention|nan|
|Behavioral: Contingency management|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention in treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion urine samples free of illicit drugs |  |  | 
| Problem severity as measured by Addiction Severity Index |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heroin dependence, methadone, buprenorphine, contingency management, relapse prevention