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
Study 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 January 15, 2009