Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

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:	NCT00000299

Purpose

The purpose of this study is to develop a clinical protocol to detoxify patients from opiates to naltrexone using buprenorphine and to develop pilot data for a grant application for a controlled study of the efficacy of the new clinical protocol for outpatients.

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

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Rapid Opiate Detoxification & Naltrexone Induction Using Bup.

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

Primary Outcome Measures:

Opiate craving
Opiate withdrawal symptoms

Estimated Enrollment:

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. Dependent 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: NCT00000299

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-09260-2, P50-09260-2
Study First Received:	September 20, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000299
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Buprenorphine
Mental Disorders
Naltrexone

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