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Sponsors and Collaborators: |
Karolinska University Hospital Swedish National Drug Policy Coordinator Stockholm County Schering-Plough |
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Information provided by: | Karolinska University Hospital |
ClinicalTrials.gov Identifier: | NCT00310934 |
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.
Condition | Intervention | Phase |
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Heroin Dependence |
Drug: methadone Drug: buprenorphine / methadone sequence Behavioral: Relapse prevention Behavioral: Contingency management |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Graded Strategy for Pharmacological Treatment of Heroin Dependence |
Estimated Enrollment: | 96 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | March 2006 |
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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Sweden | |
Dept of Clinical Neuroscience, Karolinska Inst | |
Stockholm, Sweden, 14176 |
Principal Investigator: | Markus Heilig, MD PhD | Karolinska Institute, Stockholm |
Study ID Numbers: | KarolinskaUH Regional 373/03 |
Study First Received: | April 3, 2006 |
Last Updated: | October 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00310934 History of Changes |
Health Authority: | Sweden: Regional Ethical Review Board |
heroin dependence methadone buprenorphine contingency management relapse prevention |
Heroin Dependence Heroin Narcotic Antagonists Disorders of Environmental Origin Central Nervous System Depressants Narcotics Opioid-Related Disorders Naphazoline Methadone |
Buprenorphine Guaifenesin Mental Disorders Substance-Related Disorders Phenylpropanolamine Analgesics Peripheral Nervous System Agents Analgesics, Opioid |
Respiratory System Agents Heroin Dependence Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Disorders of Environmental Origin Narcotics Opioid-Related Disorders Pharmacologic Actions Methadone |
Buprenorphine Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Analgesics Peripheral Nervous System Agents Antitussive Agents Central Nervous System Agents Analgesics, Opioid |