Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

Drug Dependence Clinical Trial

Official title:

Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096550
• Other study ID #: 1RC1DA028407-01
• Secondary ID: 1RC1DA028407-01
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2020
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 319
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• heroin-dependent adults

• new admissions to buprenorphine outpatient treatment

Exclusion Criteria:

• pregnancy

• acute medical or psychiatric illness

Related Conditions & MeSH terms

• Drug Dependence
• Substance-Related Disorders

Intervention

Behavioral:
• Outpatient
Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
• Intensive Outpatient
Buprenorphine patients receiving 9 or more hours of outpatient counseling.

Locations

Country	Name	City	State
United States	Friends Research Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)		6 months post-baseline