Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence - Full Text View

Sponsor:	Yale University
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):	David Fiellin, Yale University
ClinicalTrials.gov Identifier:	NCT00555425

Purpose

The aim of the study is to determine whether buprenorphine/naloxone maintenance versus detoxification using buprenorphine/naloxone, in prescription opioid dependent patients receiving primary care management and drug counseling in an office-based setting, leads to decreased illicit opioid use.

Condition	Intervention	Phase
Opiate Dependence	Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn) Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

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 Yale University:

Primary Outcome Measures:

Illicit opioid use [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients protectively transferred [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Retention in treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Reduction in cocaine use [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Reductions in HIV risk [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Patient satisfaction [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Health status [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Utilization and costs of services [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	July 2008
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.	Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn) Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
Experimental: 2 Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.	Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx) Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.

Arms

Assigned Interventions

Active Comparator: 1

Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.

Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn)

Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.

Experimental: 2

Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.

Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx)

Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.

Detailed Description:

Prescription opioid dependence is increasing and creates a significant public health burden, but office-based physicians lack evidence-based guidelines to decide between maintenance or detoxification treatment with buprenorphine/naloxone. The proposed study compares buprenorphine/naloxone maintenance (Mtn) vs. detoxification (Dtx) in a 18-week randomized clinical trail in a heterogeneous population of prescription opioid dependent patients (N=120) in a primary care clinic. Patients are randomized to Mtn or Dtx after a 2-week induction period. Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, buprenorphine/naloxone will continue unchanged for the remainder of the study. In Dtx, the dosage of buprenorphine/naloxone will be tapered to zero over the next 3 weeks, and patients will not receive additional buprenorphine/naloxone for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup. The study will test the hypothesis that Mtn will lead to decreased illicit drug use and will demonstrate incremental cost-effectiveness compared to Dtx. Relevance to public health: The results of this study will help define the role of maintenance vs. detoxification with buprenorphine/naloxone in the care of prescription opioid dependent patients in primary care.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

opioid dependence

Exclusion Criteria:

current dependence on alcohol, cocaine, benzodiazepines or sedatives
current suicide or homicide risk
current psychotic disorder or untreated major depression
inability to read or understand English
life-threatening or unstable medical problems

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555425

Contacts

Contact: Christopher Cutter, PhD

203-781-4650 ext 277

christopher.cutter@yale.edu

Locations

United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06520
The APT Foundation, Inc. -- Welch Building	Recruiting
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

David A. Fiellin, MD

Yale University

More Information

No publications provided

Responsible Party:	David Fiellin, Professor of Medicine, Yale University
ClinicalTrials.gov Identifier:	NCT00555425 History of Changes
Obsolete Identifiers:	NCT00595400
Other Study ID Numbers:	1R01DA020576-01A1, 1R01DA020576-01A1, R01DA020576, DPMC
Study First Received:	November 6, 2007
Last Updated:	November 29, 2011
Health Authority:	United States: Federal Government

Keywords provided by Yale University:

Buprenorphine
Buprenorphine/naloxone
Counseling
Primary care

Additional relevant MeSH terms:

Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naloxone
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