Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

NCT ID: NCT01096550

Last Updated: 2020-04-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

319 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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

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Drug Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive Outpatient

Buprenorphine patients receiving 9 or more hours of outpatient counseling.

Group Type EXPERIMENTAL

Intensive Outpatient

Intervention Type BEHAVIORAL

Buprenorphine patients receiving 9 or more hours of outpatient counseling.

Outpatient

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

Group Type ACTIVE_COMPARATOR

Outpatient

Intervention Type BEHAVIORAL

Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.

Interventions

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Outpatient

Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.

Intervention Type BEHAVIORAL

Intensive Outpatient

Buprenorphine patients receiving 9 or more hours of outpatient counseling.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* acute medical or psychiatric illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Friends Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shannon G Mitchell, PhD

Role: PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Locations

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Friends Research Institute

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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1RC1DA028407-01

Identifier Type: NIH

Identifier Source: secondary_id

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1RC1DA028407-01

Identifier Type: NIH

Identifier Source: org_study_id

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