Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1
Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic
3 other identifiers
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM enhanced with additional education about addiction and recovery (Enhanced Medical Management, EMM)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2000
Typical duration for phase_2
1 active site
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, 2000
CompletedFirst Submitted
Initial submission to the registry
August 30, 2001
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedJune 29, 2020
June 1, 2020
3.3 years
August 30, 2001
June 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Self-reported frequency of illicit opioid use
6 months
Percentage of opioid-negative urine specimens
6 months
Maximum number of weeks abstinent from illicit opioids
6 months
Study Arms (3)
1
EXPERIMENTALStandard Medical Management with once-weekly medication dispensing
2
EXPERIMENTALStandard Medical Management with thrice-weekly medication dispensing
3
EXPERIMENTALEnhanced Medical Management with thrice-weekly medication dispensing
Interventions
1. Experimental Standard Medical Management with once-weekly medication dispensing 2. Experimental Standard Medical Management with thrice-weekly medication dispensing 3. Experimental Enhanced Medical Management with thrice-weekly medication dispensing
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
APT Residential Services Division
New Haven, Connecticut, 06519, United States
Related Publications (3)
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: 40833692DERIVEDSullivan LE, Moore BA, Chawarski MC, Pantalon MV, Barry D, O'Connor PG, Schottenfeld RS, Fiellin DA. Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. J Subst Abuse Treat. 2008 Jul;35(1):87-92. doi: 10.1016/j.jsat.2007.08.004. Epub 2007 Oct 15.
PMID: 17933486DERIVEDFiellin DA, Pantalon MV, Chawarski MC, Moore BA, Sullivan LE, O'Connor PG, Schottenfeld RS. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006 Jul 27;355(4):365-74. doi: 10.1056/NEJMoa055255.
PMID: 16870915DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Schottenfeld, M.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 30, 2001
First Posted
August 31, 2001
Study Start
August 1, 2000
Primary Completion
December 1, 2003
Study Completion
February 1, 2004
Last Updated
June 29, 2020
Record last verified: 2020-06