Buprenorphine Combination Tablet Feasibility - 1

This study has been completed.

First Received: September 20, 1999 Last Updated: August 16, 2005 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Placebo Control
Official Title:	Buprenorphine Combination Tablet Feasibility

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Naloxone hydrochloride Naloxone

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	NIDA-09260-1, P50-09260-1
Study First Received:	September 20, 1999
Last Updated:	August 16, 2005
ClinicalTrials.gov Identifier:	NCT00000298 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Naloxone
Buprenorphine

Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009