Buprenorphine Formulation Comparison: Sublingual Tablet Vs. Solution - 1 - Full Text View

Buprenorphine Formulation Comparison: Sublingual Tablet Vs. Solution - 1

This study is ongoing, but not recruiting participants.

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000320

Purpose

The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."

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

ChemIDplus related topics:

Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Crossover Assignment

Official Title:	Buprenorphine Formulation Comparison: Sublingual Tablet Vs. Solution

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

Primary Outcome Measures:

Craving
Drug use
Withdrawal symptoms

Estimated Enrollment:	0
Study Start Date:	October 1997

Detailed Description:

1) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000320

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-10068-1, R01-10068-1
First Received:	September 20, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000320
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 September 05, 2008