Alternate-Day Buprenorphine Administration. Phase I - 3 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

April 1992

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Drug use
Opioid withdrawal
Opioid agonist effects
Dose identification
Pupil diameter

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000221 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Alternate-Day Buprenorphine Administration. Phase I - 3

Official Title ^ICMJE

Alternate-Day Buprenorphine Administration. Phase I

Brief Summary

The purpose of this study is to determine if two times a subject's daily maintenance dose will hold for 48 hours without changes in agonist and antagonist effects.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Double-Blind, Placebo Control, Crossover Assignment

Condition ^ICMJE

Opioid-Related Disorders

Intervention ^ICMJE

Drug: Buprenorphine

Study Arms / Comparison Groups

Publications *

Amass L, Bickel WK, Higgins ST, Badger GJ. Alternate-day dosing during buprenorphine treatment of opioid dependence. Life Sci. 1994;54(17):1215-28.

* 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

Please contact site for information.

Gender

Both

Ages

28 Years to 45 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

NCT00000221

Responsible Party

Study ID Numbers ^ICMJE

NIDA-06969-3, R01-06969-3

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

University of Vermont

Investigators ^ICMJE

Principal Investigator:

Warren Bickel, Ph.D.

University of Vermont

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

November 1993

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