NCT00595764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2007

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

October 6, 2014

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

5.5 years

First QC Date

October 3, 2007

Results QC Date

July 18, 2013

Last Update Submit

April 1, 2020

Conditions

Opiate Dependence

Keywords

BuprenorphineBuprenorphine/naloxoneCounselingPrimary care

Outcome Measures

Primary Outcomes (1)

  • Illicit Opioid Abstinence

    number of weeks of abstinence from illicit opioids, as documented by urine toxicology and self-report. Range 0 - 24.

    6 months

Secondary Outcomes (4)

  • Treatment Completion

    6 months

  • Cocaine Abstinence

    6 months

  • Criminal Activity- Addiction Severity Index (ASI) Legal Composite Score.

    6 months

  • Overall Health- Short Form (36) Health Survey

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Physician Management

Behavioral: Manual-guided Physician Management (PM)

2

EXPERIMENTAL

Physician Management plus Cognitive Behavioral Therapy

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

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.

1
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.

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • opioid dependence

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The APT Foundation, Inc. -- Welch Building

New Haven, Connecticut, 06519, United States

Location

Yale New Haven Hospital Primary Care Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (2)

  • 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.

    PMID: 23260506RESULT

  • McHugh RK, Bailey AJ, McConaghy BA, Weiss RD, Fiellin DA, Hillhouse M, Moore BA, Fitzmaurice GM. Behavioral Therapy as an Adjunct to Buprenorphine Treatment for Opioid Use Disorder: A Secondary Analysis of 4 Randomized Clinical Trials. JAMA Netw Open. 2025 Aug 1;8(8):e2528529. doi: 10.1001/jamanetworkopen.2025.28529.

    PMID: 40833692DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. David Fiellin
Organization
Yale University
david.fiellin@yale.edu
203-737-3347

Study Officials

  • David A. Fiellin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2007

First Posted

January 16, 2008

Study Start

August 1, 2005

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

April 3, 2020

Results First Posted

October 6, 2014

Record last verified: 2020-04

Locations

US(2)