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

This study has been completed.

Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
University of Colorado at Denver and Health Sciences Center
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00000328
  Purpose

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 II

MedlinePlus related topics:   Heroin   

Drug Information available for:   Naloxone    Naloxone hydrochloride    Buprenorphine    Buprenorphine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:   Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Drug use
  • Retention
  • Opioid agonist rating
  • Opioid antagonist rating
  • Compliance
  • Medication identification
  • ASI Composite Score Rating

Estimated Enrollment:   0
Study Start Date:   July 1997

Detailed Description:

S/A brief "Summary for the Public"

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Individuals must be at least 18 years of age, currently opioid dependent and meet FDA critera 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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000328

Locations
United States, Colorado
University of Colorado Health Sciences Center    
      Denver, Colorado, United States, 80206

Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of Colorado at Denver and Health Sciences Center

Investigators
Principal Investigator:     Leslie Amass, Ph.D.     University of Colorado at Denver and Health Sciences Center    
  More Information


Study ID Numbers:   NIDA-11160-3, R01-11160-3
First Received:   September 20, 1999
Last Updated:   November 3, 2005
ClinicalTrials.gov Identifier:   NCT00000328
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Buprenorphine
Mental Disorders
Heroin Dependence
Substance-Related Disorders
Disorders of Environmental Origin
Opioid-Related Disorders
Naloxone

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on October 31, 2008




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