Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules - 1

This study has been completed.

First Received on February 19, 2004. Last Updated on April 13, 2010 History of Changes

Sponsor:	University of California, Los Angeles
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00078117

Purpose

The purpose of this protocol is to to compare the clinical utility of two dosage tapering regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.

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

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules

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:

Opiate abstinence

Estimated Enrollment:	516
Study Start Date:	June 2003
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Females are not pregnant or lactating
Subjects meet DSM-IV criteria for opiate dependence, are medically and psychiatrically stable, and do not have a current history of benzodiazepine dependence abuse, dependence, or treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078117

Locations

United States, Colorado
Addiction Research & Treatment Services (ARTS)
Denver, Colorado, United States, 80204
Denver Health & Hospitals Authority
Denver, Colorado, United States, 80204
United States, Connecticut
Hartford Dispensary
Hartford, Connecticut, United States, 06120
Connecticut Counseling Centers
Waterbury, Connecticut, United States, 06705
United States, New York
LI Jewish Health System
Glen Oaks, New York, United States, 11004
New York VA Medical Center
New York, New York, United States, 10010
United States, North Carolina
South Light-Wakeview Clinic
Raleigh, North Carolina, United States, 27610
Coastal Horizons Center, Inc.
Wilmington, North Carolina, United States, 28412
United States, Oregon
CODA
Portland, Oregon, United States, 97214
United States, Virginia
Norfolk CSB
Norfolk, Virginia, United States, 23505
United States, Washington
Providence Behavioral Health Services
Everett, Washington, United States, 98201

Sponsors and Collaborators

University of California, Los Angeles

Investigators

Principal Investigator:

Walter Ling, M.D.

University of California, Los Angeles

More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Back SE, Payne RL, Wahlquist AH, Carter RE, Stroud Z, Haynes L, Hillhouse M, Brady KT, Ling W. Comparative profiles of men and women with opioid dependence: results from a national multisite effectiveness trial. Am J Drug Alcohol Abuse. 2011 Sep;37(5):313-23.

Ling W, Hillhouse M, Domier C, Doraimani G, Hunter J, Thomas C, Jenkins J, Hasson A, Annon J, Saxon A, Selzer J, Boverman J, Bilangi R. Buprenorphine tapering schedule and illicit opioid use. Addiction. 2009 Feb;104(2):256-65.

Responsible Party:	Walter Ling, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00078117 History of Changes
Other Study ID Numbers:	NIDA-CTN-0003-1
Study First Received:	February 19, 2004
Last Updated:	April 13, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012