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Counseling for Primary Care Office-based Buprenorphine

NCT00595764 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2020-04-03

Study results available
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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.

Conditions

  • Opiate Dependence

Interventions

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • David A. Fiellin, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00595764 on ClinicalTrials.gov