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A Stepwise Strategy Utilizing Buprenorphine and Methadone

This study has been completed.
Sponsor:
Collaborators:
Swedish National Drug Policy Coordinator
Stockholm County Council, Sweden
Schering-Plough
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT00310934
First received: April 3, 2006
Last updated: October 23, 2006
Last verified: March 2006
History of Changes
  Purpose

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
Heroin Dependence
 Drug: methadone
Drug: buprenorphine / methadone sequence
Behavioral: Relapse prevention
Behavioral: Contingency management
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Graded Strategy for Pharmacological Treatment of Heroin Dependence

Resource links provided by NLM:

MedlinePlus related topics: Heroin
U.S. FDA Resources

Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Retention in treatment

Secondary Outcome Measures:
  • Proportion urine samples free of illicit drugs
  • Problem severity as measured by Addiction Severity Index

Estimated Enrollment: 96
Study Start Date: August 2005
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310934

Locations
Sweden
Dept of Clinical Neuroscience, Karolinska Inst
Stockholm, Sweden, 14176
Sponsors and Collaborators
Karolinska University Hospital
Swedish National Drug Policy Coordinator
Stockholm County Council, Sweden
Schering-Plough
Investigators
Principal Investigator: Markus Heilig, MD PhD Karolinska Institute, Stockholm
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00310934     History of Changes
Other Study ID Numbers: KarolinskaUH Regional 373/03
Study First Received: April 3, 2006
Last Updated: October 23, 2006
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
heroin dependence
methadone
buprenorphine
contingency management
relapse prevention

Additional relevant MeSH terms:
Heroin Dependence
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Methadone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 16, 2013