Clinical trial NCT00078117: Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules - 1
Official title: Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-Related Disorders
Keywords: opiate dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-02-20
Enrollment: 516
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Opiate abstinence
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Addiction Research & Treatment Services (ARTS)
state: Colorado
city: Denver
country: United States
facility: Denver Health & Hospitals Authority
state: Colorado
city: Hartford
country: United States
facility: Hartford Dispensary
state: Connecticut
city: Waterbury
country: United States
facility: Connecticut Counseling Centers
state: Connecticut
city: Glen Oaks
country: United States
facility: LI Jewish Health System
state: New York
city: New York
country: United States
facility: New York VA Medical Center
state: New York
city: Raleigh
country: United States
facility: South Light-Wakeview Clinic
state: North Carolina
city: Wilmington
country: United States
facility: Coastal Horizons Center, Inc.
state: North Carolina
city: Portland
country: United States
facility: CODA
state: Oregon
city: Norfolk
country: United States
facility: Norfolk CSB
state: Virginia
city: Everett
country: United States
facility: Providence Behavioral Health Services
state: Washington
Study officials:
affiliation: University of California, Los Angeles
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.