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Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III) - 3

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: September 20, 1999
Last updated: May 5, 2016
Last verified: December 2013
The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.

Condition Intervention Phase
Heroin Dependence
Opioid-Related Disorders
Drug: Opioid-Related Disorders
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Drug use
  • Retention
  • Opioid agonist rating
  • Opioid antagonist rating
  • Compliance
  • Medication identification
  • Addiction Severity Index (ASI) Composite Score Rating

Estimated Enrollment: 0
Study Start Date: July 1997
Study Completion Date: August 1997
Primary Completion Date: August 1997 (Final data collection date for primary outcome measure)
Detailed Description:
S/A brief "Summary for the Public"

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Individuals must be at least 18 years of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.

Exclusion Criteria:

Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00000328

United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Drug Abuse (NIDA)
Principal Investigator: Leslie Amass, Ph.D. University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver Identifier: NCT00000328     History of Changes
Other Study ID Numbers: NIDA-11160-3  1R01DA011160  R01-11160-3 
Study First Received: September 20, 1999
Last Updated: May 5, 2016
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
drug dependence

Additional relevant MeSH terms:
Opioid-Related Disorders
Heroin Dependence
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Buprenorphine, Naloxone Drug Combination
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on October 21, 2016