- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00078117
Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules - 1
January 11, 2017 updated by: University of California, Los Angeles
Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules
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.
Study Overview
Study Type
Interventional
Enrollment
516
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Addiction Research & Treatment Services (ARTS)
-
Denver, Colorado, United States, 80204
- Denver Health & Hospitals Authority
-
-
Connecticut
-
Hartford, Connecticut, United States, 06120
- Hartford Dispensary
-
Waterbury, Connecticut, United States, 06705
- Connecticut Counseling Centers
-
-
New York
-
Glen Oaks, New York, United States, 11004
- LI Jewish Health System
-
New York, New York, United States, 10010
- New York VA Medical Center
-
-
North Carolina
-
Raleigh, North Carolina, United States, 27610
- South Light-Wakeview Clinic
-
Wilmington, North Carolina, United States, 28412
- Coastal Horizons Center, Inc.
-
-
Oregon
-
Portland, Oregon, United States, 97214
- CODA
-
-
Virginia
-
Norfolk, Virginia, United States, 23505
- Norfolk CSB
-
-
Washington
-
Everett, Washington, United States, 98201
- Providence Behavioral Health Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Opiate abstinence
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nielsen S, Hillhouse M, Thomas C, Hasson A, Ling W. A comparison of buprenorphine taper outcomes between prescription opioid and heroin users. J Addict Med. 2013 Jan-Feb;7(1):33-8. doi: 10.1097/ADM.0b013e318277e92e.
- Hillhouse M, Canamar CP, Ling W. Predictors of outcome after short-term stabilization with buprenorphine. J Subst Abuse Treat. 2013 Mar;44(3):336-42. doi: 10.1016/j.jsat.2012.08.016. Epub 2012 Sep 26.
- 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. doi: 10.3109/00952990.2011.596982.
- 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. doi: 10.1111/j.1360-0443.2008.02455.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
May 1, 2005
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
February 19, 2004
First Submitted That Met QC Criteria
February 19, 2004
First Posted (Estimate)
February 20, 2004
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Narcotic Antagonists
- Buprenorphine
Other Study ID Numbers
- NIDA-CTN-0003-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.