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Counseling for Primary Care Office-based Buprenorphine

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ClinicalTrials.gov Identifier: NCT00595764
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : October 6, 2014
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE October 3, 2007
First Posted Date  ICMJE January 16, 2008
Results First Submitted Date  ICMJE July 18, 2013
Results First Posted Date  ICMJE October 6, 2014
Last Update Posted Date April 3, 2020
Study Start Date  ICMJE August 2005
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2014)
Illicit Opioid Abstinence [ Time Frame: 6 months ]
number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
Illicit opioid use [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2014)
  • Treatment Completion [ Time Frame: 6 months ]
    The number of patients who completed the study (did not meet the criteria for protective transfer baseed on drug use, did not miss medication for more than seven days, or did not miss three or more Physician Management sessions) at 24 weeks.
  • Cocaine Abstinence [ Time Frame: 6 months ]
    Total weeks of cocaine abstinence as documented by weekly urine toxicology analysis. Range from 0 to 24.
  • Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score. [ Time Frame: 6 months ]
    The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.
  • Overall Health- Short Form (36) Health Survey [ Time Frame: 6 months ]
    Short Form (36) Health Survey overall score ranges from 0 to 100. Computed as the mean of all SF-36 subscales. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Lower scores are greater disability and higher scores are greater health functioning.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
  • Retention in treatment [ Time Frame: 6 months ]
  • Reductions in cocaine use and HIV risk [ Time Frame: 6 months ]
  • Decreased criminal activity [ Time Frame: 6 months ]
  • Improved health and employment status [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Counseling for Primary Care Office-based Buprenorphine
Official Title  ICMJE Counseling for Primary Care Office-based Buprenorphine
Brief Summary The major goal is to determine whether adding cognitive behavioral therapy to physician management will increase the efficacy of buprenorphine/naloxone treatment in an office-based primary care setting.
Detailed Description To evaluate the need for drug counseling aimed at reducing illicit drug use and increasing buprenorphine/naloxone adherence, the proposed study compares manual-guided Physician Management (PM) and PM combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) in a 24 week randomized clinical trial of buprenorphine/naloxone in a heterogeneous population of opioid dependent patients (N=140) in a primary care clinic. PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services. CBT will be provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing buprenorphine/naloxone adherence. The study will test the hypothesis that that the addition of CBT to PM will lead to decreased illicit drug use, durable effects after counseling has been discontinued, improved buprenorphine/naloxone adherence and will demonstrate incremental cost-effectiveness in patients receiving buprenorphine/naloxone maintenance in primary care. Primary outcome measures include reductions in illicit opioid use and abstinence achievement, as assessed by weekly urine toxicology testing and self report. Secondary outcome measures include retention in treatment, reductions in cocaine use and HIV risk, decreased criminal activity and improved health and employment status. Utilization and costs of services, spillover effects in the PCC, and patient and staff perceptions of benefits and problems associated with primary care agonist maintenance treatment will also be evaluated. The results of this study will help define the role of professional evidence-based drug counseling in expanding access to treatment with buprenorphine/naloxone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opiate Dependence
Intervention  ICMJE
  • Behavioral: Manual-guided Physician Management (PM)
    Manual-guided Physician Management (PM) PM, consistent with federal regulations, is designed to reflect usual care by primary care physicians and includes referral to ancillary services.
  • Behavioral: Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)
    CBT is provided by skilled psychologists in weekly sessions for the first 12 weeks and focuses on reducing illicit drug use and increasing Buprenorphine adherence.
Study Arms  ICMJE
  • Active Comparator: 1
    Physician Management
    Intervention: Behavioral: Manual-guided Physician Management (PM)
  • Experimental: 2
    Physician Management plus Cognitive Behavioral Therapy
    Intervention: Behavioral: Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)
Publications * Fiellin DA, Barry DT, Sullivan LE, Cutter CJ, Moore BA, O'Connor PG, Schottenfeld RS. A randomized trial of cognitive behavioral therapy in primary care-based buprenorphine. Am J Med. 2013 Jan;126(1):74.e11-7. doi: 10.1016/j.amjmed.2012.07.005.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2012)
141
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2008)
140
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00595764
Other Study ID Numbers  ICMJE 0504027657
5R01DA019511 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: David A. Fiellin, MD Yale University
PRS Account Yale University
Verification Date April 2020

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