Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

April 18, 2001

Last Updated Date

November 3, 2005

Start Date ^ICMJE

April 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Craving
Drug use
Retention
Opioid withdrawal
Subjective rating

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00015171 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Buprenorphine and Naloxone for the Treatment of Opiate Dependence - 1

Official Title ^ICMJE

CS1008 A&B Eff/Safety Trial of BUP/NX for the Treatment of Opiate Dependence

Brief Summary

The purpose of this study is the use of buprenorphine/naloxone in treatment of opioid dependence.

Detailed Description

The objective of this study is to determine the safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Heroin Dependence
Substance-Related Disorders

Intervention ^ICMJE

Drug: Buprenorphine/naloxone

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:

DSM-IV diagnosis of current opiate dependence males and non-pregnant, non-nursing female 18-59 yrs of age

Exclusion Criteria:

Any significant medical condition AST or ALT levels greater than 3x's the upper limit of normal level Current Axis I diagnosis other than opiate, caffeine or nicotine dependence

Gender

Both

Ages

18 Years to 59 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

NCT00015171

Responsible Party

Study ID Numbers ^ICMJE

NIDA-5-0013-1, Y01-5-0013-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

New York MDRU

Investigators ^ICMJE

Principal Investigator:

John Rotrosen, M.D.

New York MDRU

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

January 1999

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