Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans
Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans
1 other identifier
interventional
319
1 country
1
Brief Summary
The purpose of this study is to compare the effectiveness of different levels of counseling (intensive outpatient versus standard outpatient) on treatment outcomes for African American adult patients receiving buprenorphine in 2 formerly "drug-free" programs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 30, 2010
CompletedFirst Posted
Study publicly available on registry
March 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
October 17, 2013
CompletedApril 8, 2020
March 1, 2020
1.6 years
March 30, 2010
August 13, 2013
March 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)
6 months post-baseline
Study Arms (2)
Intensive Outpatient
EXPERIMENTALBuprenorphine patients receiving 9 or more hours of outpatient counseling.
Outpatient
ACTIVE COMPARATORBuprenorphine patients receiving between 2 and 8 hours of outpatient counseling.
Interventions
Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Eligibility Criteria
You may qualify if:
- heroin-dependent adults
- new admissions to buprenorphine outpatient treatment
You may not qualify if:
- pregnancy
- acute medical or psychiatric illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Friends Research Institute
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
OP condition participants received more counseling services at the clinics as part of their regular care than was initially expected and IOP condition participants received slightly less that 9 hours of counseling, on average.
Results Point of Contact
- Title
- Dr. Shannon Gwin Mitchell
- Organization
- Friends Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon G Mitchell, PhD
Friends Research Institute, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2010
First Posted
March 31, 2010
Study Start
March 1, 2010
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
April 8, 2020
Results First Posted
October 17, 2013
Record last verified: 2020-03