Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

Friends Research Institute

Status: Completed

Conditions: Drug Dependence

Treatments: Behavioral: Intensive Outpatient; Behavioral: Outpatient

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01096550

1RC1DA028407-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 319 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnancy
• acute medical or psychiatric illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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319 participants in 2 patient groups

Intensive Outpatient

Experimental group

Description:

Buprenorphine patients receiving 9 or more hours of outpatient counseling.

Treatment:

Behavioral: Intensive Outpatient

Outpatient

Active Comparator group

Description:

Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.

Treatment:

Behavioral: Outpatient