Clinical Trials Directory

Trials / Completed

CompletedNCT01096550

Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
319 (actual)
Sponsor
Friends Research Institute, Inc. · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALOutpatientBuprenorphine patients receiving 2 to 8 hours of outpatient counseling.
BEHAVIORALIntensive OutpatientBuprenorphine patients receiving 9 or more hours of outpatient counseling.

Timeline

Start date
2010-03-01
Primary completion
2011-10-01
Completion
2011-10-01
First posted
2010-03-31
Last updated
2020-04-08
Results posted
2013-10-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01096550. Inclusion in this directory is not an endorsement.