Counseling for Primary Care Office-based Buprenorphine

Phase 4

Completed

• Conditions: Opiate Dependence
• Interventions: Behavioral: Manual-guided Physician Management (PM); Behavioral: Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)

• Registration Number: NCT00595764
• Lead Sponsor: Yale University

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 Timeline

• Study Start: 2005-08
• Study First Submitted: 2007-10-03
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-16
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2013-07-18
• Results First Submitted QC: 2014-09-30
• Results First Posted: 2014-10-06
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Manual-guided Physician Management (PM)	Physician Management
2	Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)	Physician Management plus Cognitive Behavioral Therapy

Primary Outcome Measures

Name	Time	Method
Illicit Opioid Abstinence	6 months	number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.

Secondary Outcome Measures

Name	Time	Method
Treatment Completion	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.
Overall Health- Short Form (36) Health Survey	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.
Cocaine Abstinence	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.	6 months	The ASI Legal Composite score ranges from 0 to 1 with higher scores corresponding to greater legal problems.

Trial Locations

Locations (2)

The APT Foundation, Inc. -- Welch Building; 🇺🇸 New Haven, Connecticut, United States

Yale New Haven Hospital Primary Care Center; 🇺🇸 New Haven, Connecticut, United States