Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

Not Applicable

Completed

• Conditions: Drug Dependence
• Interventions: Behavioral: Intensive Outpatient; Behavioral: Outpatient

• Registration Number: NCT01096550
• Lead Sponsor: Friends Research Institute, Inc.

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2013-08-13
• Results First Submitted QC: 2013-08-13
• Results First Posted: 2013-10-17
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

Inclusion Criteria

• heroin-dependent adults
• new admissions to buprenorphine outpatient treatment

Exclusion Criteria

• pregnancy
• acute medical or psychiatric illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Outpatient	Intensive Outpatient	Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Outpatient	Outpatient	Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)	6 months post-baseline

Trial Locations

Locations (1)

Friends Research Institute; 🇺🇸 Baltimore, Maryland, United States