Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2

This study has been completed.

First Received: September 20, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Drug Information available for: Naltrexone Naltrexone hydrochloride Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	NIDA-09260-2, P50-09260-2
Study First Received:	September 20, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000299 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
Buprenorphine
Mental Disorders

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

ClinicalTrials.gov processed this record on November 27, 2009