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Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01096550
First Posted: March 31, 2010
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Friends Research Institute, Inc.
  Purpose
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.

Condition Intervention Phase
Drug Dependence Behavioral: Outpatient Behavioral: Intensive Outpatient Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Outpatient v. Outpatient Treatment With Buprenorphine Among African Americans

Resource links provided by NLM:


Further study details as provided by Friends Research Institute, Inc.:

Primary Outcome Measures:
  • Percentage of Participants Meeting Diagnosis of Opioid Dependence on Composite International Diagnostic Interview-2 (CIDI-2) [ Time Frame: 6 months post-baseline ]

Enrollment: 319
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive Outpatient
Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Behavioral: Intensive Outpatient
Buprenorphine patients receiving 9 or more hours of outpatient counseling.
Active Comparator: Outpatient
Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.
Behavioral: Outpatient
Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • acute medical or psychiatric illness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096550


Locations
United States, Maryland
Friends Research Institute
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Friends Research Institute, Inc.
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Shannon G Mitchell, PhD Friends Research Institute, Inc.
  More Information

Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01096550     History of Changes
Other Study ID Numbers: 1RC1DA028407-01 ( U.S. NIH Grant/Contract )
First Submitted: March 30, 2010
First Posted: March 31, 2010
Results First Submitted: August 13, 2013
Results First Posted: October 17, 2013
Last Update Posted: April 15, 2015
Last Verified: March 2015

Keywords provided by Friends Research Institute, Inc.:
opioid dependence
outpatient treatment
intensive outpatient treatment

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists