Evaluation of Liquid vs. Tablet Buprenorphine - 6 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 1999

Last Updated Date

August 26, 2008

Start Date ^ICMJE

August 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Subjective and observer rater physiological effects of bup

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00000341 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Evaluation of Liquid vs. Tablet Buprenorphine - 6

Official Title ^ICMJE

Pharmacokinetics and Bioavailability of Liquid vs Tablet Buprenorphine

Brief Summary

The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Crossover Assignment

Condition ^ICMJE

Opioid-Related Disorders

Intervention ^ICMJE

Drug: Buprenorphine

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

August 2000

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

M/F ages 21-50. Meet DSM-IV criteria for opioid dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Gender

Both

Ages

21 Years to 50 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

NCT00000341

Responsible Party

Study ID Numbers ^ICMJE

NIDA-3-0010-6, Y01-3-0010-6

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

August 2008

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