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Randomized Controlled Trial
. 2013 Mar 1;128(3):222-9.
doi: 10.1016/j.drugalcdep.2012.08.027. Epub 2012 Sep 20.

A randomized trial of intensive outpatient (IOP) vs. standard outpatient (OP) buprenorphine treatment for African Americans

Shannon Gwin Mitchell  1 , Jan Gryczynski, Robert P Schwartz, Kevin E O'Grady, Yngvild K Olsen, Jerome H Jaffe
Affiliations
Randomized Controlled Trial

A randomized trial of intensive outpatient (IOP) vs. standard outpatient (OP) buprenorphine treatment for African Americans

Shannon Gwin Mitchell et al. Drug Alcohol Depend. .

Erratum in

Abstract

Background: Buprenorphine is increasingly being used in community-based treatment programs, but little is known about the optimal level of psychosocial counseling in these settings. The aim of this study was to compare the effectiveness of OP and IOP level counseling when provided as part of buprenorphine treatment for opioid-dependent African Americans.

Methods: Participants were African American men and women starting buprenorphine treatment at one of two community-based clinics (N=300). Participants were randomly assigned to OP or IOP. Measures at baseline, 3- and 6-month included the primary outcome of DSM-IV opioid and cocaine dependence criteria, as well as additional outcomes of illicit opioid and cocaine use (urine test and self-report), criminal activity, retention in treatment, Quality of Life, Addiction Severity Index composite scores, and HIV risk behaviors.

Results: Participants assigned to OP received, on average, 3.67 (SD=1.30)h of counseling per active week in treatment. IOP participants received an average of 5.23 (SD=1.68)h of counseling per active week (less than the anticipated 9h per week of counseling). Both groups showed substantial improvement over a 6-month period on nearly all measures considered. There were no significant differences between groups in meeting diagnostic criteria for opioid (p=.67) or cocaine dependence (p=.63). There were no significant between group differences on any of the other outcomes. A secondary analysis restricting the sample to participants meeting DSM-IV criteria for baseline cocaine dependence also revealed no significant between-group differences (all ps>.05).

Conclusions: Buprenorphine patients receiving OP and IOP levels of care both show short-term improvements.

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Conflict of interest statement

Conflict of Interest

Dr. Olsen was the BSAS Medical Director from 2009 to 2011. Dr. O’Grady has consulted with Reckitt Benckiser Pharmaceuticals, Inc. Other authors report no conflicts of interest.

Figures

Figure 1
Figure 1. Study flow

  1. Passive declines included failure to keep enrollment appointments after expressing initial interest in the study.

  2. Active declines included direct verbal refusal to participate after discussing the study with research personnel.

  3. Comprehension Difficulties included severe cognitive impairment/inability to respond to basic questions.

  4. Randomization was conducted through a block random assignment procedure, such that in each block of 4 participants 2 were assigned to each condition. Participants and interviewers were blind to assignment during the baseline interview.

  5. Follow-up rates:

    3 months: 95.7% (overall); 96.1% (OP condition); 95.2% (IOP condition).

    6 months: 93.0% (overall); 94.2% (OP condition); 91.7% (IOP condition).

See this image and copyright information in PMC

References

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