NCT00078117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
516

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2003

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

January 12, 2017

Status Verified

April 1, 2010

Enrollment Period

1.9 years

First QC Date

February 19, 2004

Last Update Submit

January 11, 2017

Conditions

Keywords

opiate dependence

Outcome Measures

Primary Outcomes (1)

  • Opiate abstinence

Interventions

Eligibility Criteria

Age15 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Addiction Research & Treatment Services (ARTS)

Denver, Colorado, 80204, United States

Location

Denver Health & Hospitals Authority

Denver, Colorado, 80204, United States

Location

Hartford Dispensary

Hartford, Connecticut, 06120, United States

Location

Connecticut Counseling Centers

Waterbury, Connecticut, 06705, United States

Location

LI Jewish Health System

Glen Oaks, New York, 11004, United States

Location

New York VA Medical Center

New York, New York, 10010, United States

Location

South Light-Wakeview Clinic

Raleigh, North Carolina, 27610, United States

Location

Coastal Horizons Center, Inc.

Wilmington, North Carolina, 28412, United States

Location

CODA

Portland, Oregon, 97214, United States

Location

Norfolk CSB

Norfolk, Virginia, 23505, United States

Location

Providence Behavioral Health Services

Everett, Washington, 98201, United States

Location

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Walter Ling, M.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2004

First Posted

February 20, 2004

Study Start

June 1, 2003

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

January 12, 2017

Record last verified: 2010-04

Locations