Buprenorphine Combination Tablet Feasibility - 1 - Full Text View

Buprenorphine Combination Tablet Feasibility - 1

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:	NCT00000298

Purpose

The purpose of this study is to determine target dose range of buprenorphine/naloxone combination tablet that provides therapeutic response in opiate addicts with low to moderate dependence, and to identify appropriate initial induction dose in opiate addicts with low to moderate dependence."

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

ChemIDplus related topics:

Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Placebo Control

Official Title:	Buprenorphine Combination Tablet Feasibility

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

Primary Outcome Measures:

Withdrawal symptoms
Opiate use
Opiate craving

Estimated Enrollment:	0
Study Start Date:	August 1995

Eligibility

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

Criteria

Inclusion Criteria:

Males/Females ages 21-50, opiate dependence according to DSM-IV criteria, self-reported use within the last 30 days, agreeable to conditions of study and signed informed consent

Exclusion Criteria:

Psychiatric disorder that requires medication therapy, history of seizures, pregnant and/or nursing women, dependence on etoh or benzodiazepines or other sedative-hypnotics, acute hepatitis, other medical conditions that deem participation to be unsafe.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000298

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-09260-1, P50-09260-1
First Received:	September 20, 1999
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00000298
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

Naloxone

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