Back to resultsA Stepwise Strategy Utilizing Buprenorphine and Methadone
Primary Purpose
Heroin Dependence
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
methadone
buprenorphine / methadone sequence
Relapse prevention
Contingency management
Sponsored by
About this trial
This is an interventional treatment trial for Heroin Dependence focused on measuring heroin dependence, methadone, buprenorphine, contingency management, relapse prevention
Eligibility 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.
Sites / Locations
- Dept of Clinical Neuroscience, Karolinska Inst
Outcomes
Primary Outcome Measures
Retention in treatment
Secondary Outcome Measures
Proportion urine samples free of illicit drugs
Problem severity as measured by Addiction Severity Index
Full Information
NCT ID
NCT00310934
First Posted
April 3, 2006
Last Updated
October 23, 2006
Sponsor
Karolinska University Hospital
Collaborators
Swedish National Drug Policy Coordinator, Region Stockholm, Schering-Plough
1. Study Identification
Unique Protocol Identification Number
NCT00310934
Brief Title
A Stepwise Strategy Utilizing Buprenorphine and Methadone
Official Title
Graded Strategy for Pharmacological Treatment of Heroin Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Karolinska University Hospital
Collaborators
Swedish National Drug Policy Coordinator, Region Stockholm, Schering-Plough
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence
Keywords
heroin dependence, methadone, buprenorphine, contingency management, relapse prevention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
96 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
methadone
Intervention Type
Drug
Intervention Name(s)
buprenorphine / methadone sequence
Intervention Type
Behavioral
Intervention Name(s)
Relapse prevention
Intervention Type
Behavioral
Intervention Name(s)
Contingency management
Primary Outcome Measure Information:
Title
Retention in treatment
Secondary Outcome Measure Information:
Title
Proportion urine samples free of illicit drugs
Title
Problem severity as measured by Addiction Severity Index
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Heilig, MD PhD
Organizational Affiliation
Karolinska Institute, Stockholm
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Clinical Neuroscience, Karolinska Inst
City
Stockholm
ZIP/Postal Code
14176
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Stepwise Strategy Utilizing Buprenorphine and Methadone
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