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Clinical Trials/NCT04693416
NCT04693416
Completed
Phase 2

SMART Trial: Reducing Stigma Towards Opioid Use Disorder on the Intrapersonal and Interpersonal Levels

University of Tennessee1 site in 1 country71 target enrollmentMarch 8, 2021

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Stigma, Social
Sponsor
University of Tennessee
Enrollment
71
Locations
1
Primary Endpoint
Enacted Stigma (Intrapersonal)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The goal of this project is to develop a multicomponent stigma reduction intervention to address intrapersonal (individual) stigma regarding Opioid Use Disorder (OUD). The intervention will address this cost/benefit evaluation among individuals known to face intersecting stigma of OUD and African American race, with treatment elements chosen explicitly to increase the value of treatment using salient forms of reward, and to ease perceived costs through explicit services in an effort to encourage the occurrence of the first treatment visit for OUD.

Registry
clinicaltrials.gov
Start Date
March 8, 2021
End Date
August 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Derefinko, PhD

Assistant Professor

University of Tennessee

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older
  • Identify as African American, Black, or mixed race
  • Identify as someone with a substance use disorder who is not currently in treatment OR a support person of someone enrolled
  • Access to a telephone for follow-up assessment
  • Reside in the Memphis, TN area

Exclusion Criteria

  • Unable to understand consent procedures

Outcomes

Primary Outcomes

Enacted Stigma (Intrapersonal)

Time Frame: Immediately before and 2-weeks post-intervention delivery

Change in Enacted Stigma subscore from Substance Use Stigma Mechanisms Scale (SU-SMS) pre- and post-intervention. All responses are given on a 5-point Likert-type scale, with higher scores indicating greater endorsement of substance use stigma. Enacted (6 items) scale can be created by taking the average of the item responses given. Minimum score = 6, Maximum score = 30. Reported mean is the change in these scores (pre score - post score), so a positive number for the mean is a reduction in stigma using average scores from the Enacted Stigma subscore.

Internalized Stigma (Intrapersonal)

Time Frame: Immediately before and 2-weeks post-intervention delivery

Change in Internalized Stigma subscore from Substance Use Stigma Mechanisms Scale (SU-SMS) pre- and post-intervention. All responses are given on a 5-point Likert-type scale, with higher scores indicating greater endorsement of substance use stigma. Enacted (6 items) scale can be created by taking the average of the item responses given. Minimum score = 6, Maximum score = 30. Reported mean is the change in these scores (pre score - post score), so a positive number for the mean is a reduction in stigma using average scores from the Internalized Stigma subscore.

Stigma of Drug Users Scale Score

Time Frame: Pre/post intervention (week 0: post-test immediately followed intervention)

The Stigma of Drug Users Scale measures stigma. There are 10 items scored on a 5-point likert scale. Higher scores indicate higher stigma. The score is the average of the 10 items (Min score = 1, Max score = 5). The reported mean for this outcome measure is the change in this score pre and post intervention (pre score - post score). A positive mean indicates a reduction in stigma.

Anticipated Stigma (Intrapersonal)

Time Frame: Immediately before and 2-weeks post-intervention delivery

Change in Anticipated Stigma subscore from Substance Use Stigma Mechanisms Scale (SU-SMS) pre- and post-intervention. All responses are given on a 5-point Likert-type scale, with higher scores indicating greater endorsement of substance use stigma. Enacted (6 items) scale can be created by taking the average of the item responses given. Minimum score = 6, Maximum score = 30. Reported mean is the change in these scores (pre score - post score), so a positive number for the mean is a reduction in stigma using average scores from the Anticipated Stigma subscore.

Exposure to Drug Users Index Score

Time Frame: Pre/post intervention (week 0)

Exposure to drug users index includes questions regarding if a participant has been exposed to a drug user at home, at work, at school, etc. (7 items; No = 0, Yes = 1). Score is total count (min score = 0, max score = 7). Higher scores indicate more exposure to drug users. Reported mean is the change in this score pre and post intervention (post score - pre score).

Drug Use Stigmatization Scale Score

Time Frame: Pre/post intervention (week 0: post-test immediately followed intervention)

The Drug Use Stigmatization Scale measures stigma against drug users. The scale contains 7 items scored on a 5-point likert scale with higher scores representing higher stigma. The score is the average score of the seven items. Min score = 1, Max score = 5. Reported mean is the change in these scores (pre score - post score), so a positive number for the mean is a reduction in stigma.

Secondary Outcomes

  • Engagement in Treatment(2-weeks post-intervention)

Study Sites (1)

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