Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

December 17, 2008

Start Date ^ICMJE

December 1994

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Opioid and cocaine use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Social and psychological functioning [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
AIDS risk behavior [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Opioid and cocaine use
Social and psychological functioning
AIDS risk behavior
Depression
Withdrawal symptoms
Opiate withdrawal symptoms

Change History

Complete list of historical versions of study NCT00000318 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1

Official Title ^ICMJE

Buprenorphine Maintenance Dose Schedule and Treatment Setting: Pilot

Brief Summary

The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly schedule in a pilot clinical trial.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Endpoint Classification:  Efficacy Study
Intervention Model:  Factorial Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Opioid-Related Disorders
Substance-Related Disorders

Intervention ^ICMJE

Drug: Buprenorphine

Experimental Maintenance treatment with daily medication
Experimental Maintenance treatment with thrice-weekly medication

Study Arms / Comparison Groups

1: Experimental
Maintenance treatment with daily medication

Intervention: Drug: Buprenorphine
2: Experimental
Maintenance treatment with thrice-weekly medication

Intervention: Drug: Buprenorphine

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

202

Completion Date

August 2007

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Please contact site for information.

Gender

Both

Ages

21 Years to 55 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

NCT00000318

Responsible Party

Richard S. Schottenfeld, MD, Yale University School of Medicine

Study ID Numbers ^ICMJE

NIDA-09803-1, R01-09803-1

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Yale University

Investigators ^ICMJE

Principal Investigator:

Richard Schottenfeld, M.D.

Yale University

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

December 2008

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