CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 141 enrolled
Drug / intervention
Manual-guided Physician Management (PM) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00595764
NCT00595764Phase 4Completed
CompareCT.gov

Counseling for Primary Care Office-based Buprenorphine

Yale University·interventional·Posted Jan 16, 2008·Updated Apr 3, 2020

In Brief

A Phase 4 clinical trial evaluating Manual-guided Physician Management (PM) and Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT) for Opiate Dependence. Completed, enrolled 141 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpiate Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 16, 2008
Enrollment StartAug 1, 2005
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 18.5 years ago

Interventions

Manual-guided Physician Management (PM)behavioral

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.

Physician Management (PM) combined with on-site manual-guided Cognitive Behavioral Therapy (CBT)behavioral

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.