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

Primary Purpose

Opioid-Related Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring opiate dependence

Eligibility Criteria

15 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Addiction Research & Treatment Services (ARTS)
  • Denver Health & Hospitals Authority
  • Hartford Dispensary
  • Connecticut Counseling Centers
  • LI Jewish Health System
  • New York VA Medical Center
  • South Light-Wakeview Clinic
  • Coastal Horizons Center, Inc.
  • CODA
  • Norfolk CSB
  • Providence Behavioral Health Services

Outcomes

Primary Outcome Measures

Opiate abstinence

Secondary Outcome Measures

Full Information

First Posted
February 19, 2004
Last Updated
January 11, 2017
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00078117
Brief Title
Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules - 1
Official Title
Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders
Keywords
opiate dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
516 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Primary Outcome Measure Information:
Title
Opiate abstinence

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addiction Research & Treatment Services (ARTS)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Denver Health & Hospitals Authority
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Hartford Dispensary
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06120
Country
United States
Facility Name
Connecticut Counseling Centers
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06705
Country
United States
Facility Name
LI Jewish Health System
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
New York VA Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
South Light-Wakeview Clinic
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Coastal Horizons Center, Inc.
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28412
Country
United States
Facility Name
CODA
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Norfolk CSB
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23505
Country
United States
Facility Name
Providence Behavioral Health Services
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23222095
Citation
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.
Results Reference
derived
PubMed Identifier
23021099
Citation
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.
Results Reference
derived
PubMed Identifier
21854273
Citation
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.
Results Reference
derived
PubMed Identifier
19149822
Citation
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.
Results Reference
derived

Learn more about this trial

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

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