Back to resultsIntensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans
Primary Purpose
Drug Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outpatient
Intensive Outpatient
Sponsored by
About this trial
This is an interventional treatment trial for Drug Dependence focused on measuring opioid dependence, outpatient treatment, intensive outpatient treatment
Eligibility Criteria
Inclusion Criteria:
- heroin-dependent adults
- new admissions to buprenorphine outpatient treatment
Exclusion Criteria:
- pregnancy
- acute medical or psychiatric illness
Sites / Locations
- Friends Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive Outpatient
Outpatient
Arm Description
Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.
Outcomes
Primary Outcome Measures
Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)
Secondary Outcome Measures
Full Information
NCT ID
NCT01096550
First Posted
March 30, 2010
Last Updated
March 31, 2020
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01096550
Brief Title
Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans
Official Title
Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 2 formerly "drug-free" programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Dependence
Keywords
opioid dependence, outpatient treatment, intensive outpatient treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
319 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive Outpatient
Arm Type
Experimental
Arm Description
Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Arm Title
Outpatient
Arm Type
Active Comparator
Arm Description
Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.
Intervention Type
Behavioral
Intervention Name(s)
Outpatient
Intervention Description
Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
Intervention Type
Behavioral
Intervention Name(s)
Intensive Outpatient
Intervention Description
Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Primary Outcome Measure Information:
Title
Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)
Time Frame
6 months post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
heroin-dependent adults
new admissions to buprenorphine outpatient treatment
Exclusion Criteria:
pregnancy
acute medical or psychiatric illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon G Mitchell, PhD
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
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Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans
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