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

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

November 3, 2005

Start Date ^ICMJE

July 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Drug use
Retention
Opioid agonist rating
Opioid antagonist rating
Compliance
Medication identification
ASI Composite Score Rating

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000328 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III

Brief Summary

The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.

Detailed Description

S/A brief "Summary for the Public"

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Heroin Dependence
Opioid-Related Disorders

Intervention ^ICMJE

Drug: Opioid-Related Disorders

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000328

Responsible Party

Study ID Numbers ^ICMJE

NIDA-11160-3, R01-11160-3

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

University of Colorado at Denver and Health Sciences Center

Investigators ^ICMJE

Principal Investigator:

Leslie Amass, Ph.D.

University of Colorado at Denver and Health Sciences Center

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

July 1997

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP