Intensive Outpatient Versus Outpatient Treatment With Buprenorphine Among African Americans

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shannon Gwin Mitchell, Ph.D., Friends Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01096550
First received: March 30, 2010
Last updated: August 13, 2013
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096550

Locations
United States, Maryland
Friends Research Institute
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Friends Research Institute, Inc.
Investigators
Principal Investigator: Shannon G Mitchell, PhD Friends Research Institute, Inc.
  More Information

No publications provided

Responsible Party: Shannon Gwin Mitchell, Ph.D., Senior Research Scientist, Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01096550     History of Changes
Other Study ID Numbers: 1RC1DA028407-01, 1RC1DA028407-01
Study First Received: March 30, 2010
Results First Received: August 13, 2013
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014