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Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555425
First Posted: November 8, 2007
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
David Fiellin, Yale University
November 6, 2007
November 8, 2007
January 25, 2016
January 24, 2017
March 7, 2017
July 2008
May 2013   (Final data collection date for primary outcome measure)
Illicit Opioid Use [ Time Frame: 18 weeks ]
Urinalysis based on scheduled weekly urine screenings during treatment period
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 ]
    >= 2 consecutive weeks of daily illicit opioid use and opioid positive urine samples after completion of the first 6 weeks of the study
  • Retention in Treatment [ Time Frame: 18 weeks ]
    Mean number of days from randomization to last clinical contact
  • Reduction in Cocaine Use [ Time Frame: 18 weeks ]
    As measured by the percent of provided urines positive for cocaine
  • Changes in HIV Risk [ Time Frame: Baseline and 18 weeks ]

    As measured by the AIDS Risk Inventory. The AIDS Risk Inventory (ARI) is a 166 item structured interview that assesses the number and frequency of drug-related and sexual risk behaviors in the preceding 3 months. Calculation of the ARI total score is based on the frequency of occurrence of a given behavior and on the recency of this behavior, with recency being weighted more than a life-time occurrence of the same behavior. Higher values are associated with greater risk of HIV transmission (worse).

    There are 10 subscales comprised of between 8 and 24 items. Subscales scores are based on the sum of the individual items and the overall ARI total score is the sum of the subscales.

    Scores can range from 0 to 350, although among opioid dependent patients most values are below 100 with means between 50 and 60 depending on characteristics of the patients and treatment status.

  • Patient Satisfaction [ Time Frame: 18 weeks ]
    Patient satisfaction as measured by survey. Primary Care Buprenorphine Satisfaction Scale (PCBSS). Comprises of 19 items evaluating satisfaction with staff expertise, concern, and responsiveness. Range of scores from 15-95. I higher score indicates greater satisfaction.
  • Health Status [ Time Frame: 18 weeks ]
    Measured by the SF-36 overall transformed measure. In the SF-36 all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
  • 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
Intervention Model: Parallel Assignment
Masking: None (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)
Fiellin DA, Schottenfeld RS, Cutter CJ, Moore BA, Barry DT, O'Connor PG. Primary care-based buprenorphine taper vs maintenance therapy for prescription opioid dependence: a randomized clinical trial. JAMA Intern Med. 2014 Dec;174(12):1947-54. doi: 10.1001/jamainternmed.2014.5302.

*   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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00555425
1R01DA020576-01A1( U.S. NIH Grant/Contract )
1R01DA020576-01A1 ( U.S. NIH Grant/Contract )
R01DA020576 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
No
Not Provided
Not Provided
David Fiellin, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: David A. Fiellin, MD Yale University
Yale University
January 2017

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