Evaluation of Liquid vs. Tablet Buprenorphine - 6

This study has been completed.

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000341

Purpose

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

Condition	Intervention	Phase
Opioid-Related Disorders	Drug: Buprenorphine	Phase II

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment
Official Title:	Pharmacokinetics and Bioavailability of Liquid vs Tablet Buprenorphine

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Subjective and observer rater physiological effects of bup

Estimated Enrollment:	1
Study Start Date:	August 1996
Study Completion Date:	August 2000

Eligibility

Ages Eligible for Study:	21 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000341

Locations

United States, California
Friends Research Institute
Los Angeles, California, United States, 90025

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Walter Ling, M.D.

Friends Research Institute, Inc.

More Information

Study ID Numbers:	NIDA-3-0010-6, Y01-3-0010-6
Study First Received:	September 20, 1999
Last Updated:	August 26, 2008
ClinicalTrials.gov Identifier:	NCT00000341
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Buprenorphine
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Opioid-Related Disorders

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 15, 2009