Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Fiellin, Yale University
ClinicalTrials.gov Identifier:
NCT00555425
First received: November 6, 2007
Last updated: July 19, 2013
Last verified: July 2013

November 6, 2007
July 19, 2013
July 2008
May 2013   (final data collection date for primary outcome measure)
Illicit opioid use [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Illicit opioid use [ Time Frame: 18 weeks ]
Complete list of historical versions of study NCT00555425 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Proportion of patients protectively transferred [ Time Frame: 18 weeks ]
  • Retention in treatment [ Time Frame: 18 weeks ]
  • Reduction in cocaine use [ Time Frame: 18 weeks ]
  • Reductions in HIV risk [ Time Frame: 18 weeks ]
  • Patient satisfaction [ Time Frame: 18 weeks ]
  • Health status [ Time Frame: 18 weeks ]
  • Utilization and costs of services [ Time Frame: 18 weeks ]
Not Provided
Not Provided
 
Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence
Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Opiate Dependence
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn)
  • 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.
    Intervention: Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00555425
1R01DA020576-01A1, 1R01DA020576-01A1, R01DA020576, DPMC
No
David Fiellin, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: David A. Fiellin, MD Yale University
Yale University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP