- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00310934
A Stepwise Strategy Utilizing Buprenorphine and Methadone
Graded Strategy for Pharmacological Treatment of Heroin Dependence
Study Overview
Status
Conditions
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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Stockholm, Sweden, 14176
- Dept of Clinical Neuroscience, Karolinska Inst
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Retention in treatment
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Secondary Outcome Measures
Outcome Measure |
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Proportion urine samples free of illicit drugs
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Problem severity as measured by Addiction Severity Index
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Markus Heilig, MD PhD, Karolinska Institute, Stockholm
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Heroin Dependence
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Respiratory System Agents
- Antitussive Agents
- Buprenorphine
- Methadone
Other Study ID Numbers
- KarolinskaUH Regional 373/03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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