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Completed

NCT Number: NCT01096550

Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

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.

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Key information

Conditions

Drug Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friends Research Institute

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnancy
  • acute medical or psychiatric illness

Treatment and study plan

Outpatient

Behavioral

Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.

Intensive Outpatient

Behavioral

Buprenorphine patients receiving 9 or more hours of outpatient counseling.

Primary outcomes

  1. Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2)

    Time frame: 6 months post-baseline

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2010
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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