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

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Yale University
Information provided by:	National Institute on Drug Abuse (NIDA)
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

Drug Information available for: Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

Further study details as provided by National Institute on Drug Abuse (NIDA):

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:	April 2012
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Experimental 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

1: Active Comparator

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.

2: Experimental

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: Declan T. Barry, PhD

203-781-4650 ext 268

declan.barry@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

National Institute on Drug Abuse (NIDA)

Yale University

Investigators

Principal Investigator:

David A. Fiellin, MD

Yale University

More Information

Responsible Party:	Yale University School of Medicine ( David A. Fiellin, M.D. )
Study ID Numbers:	1R01DA020576-01A1
Study First Received:	November 6, 2007
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00555425
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Buprenorphine
Buprenorphine/naloxone
Counseling
Primary care

Study placed in the following topic categories:

Buprenorphine
Mental Disorders
Naltrexone
Substance-Related Disorders

Disorders of Environmental Origin
Opioid-Related Disorders
Naloxone

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 15, 2009