Skip to main content
OpenTrials
Completed

NCT Number: NCT04693416

SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stigma, Social Behavior Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Use Opioid-Related Disorders Opioid-use Disorder Social Behavior Social Stigma Substance Use Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrapersonal Stigma Reduction

Other

Brief intervention for stigma reduction

Interpersonal Stigma Reduction

Other

Brief intervention for support persons of intrapersonal intervention participants.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

Secondary outcomes

  1. Engagement in Treatment

    Time frame: 2-weeks post-intervention

    Number of participants in intrapersonal arm who made an appointment for treatment after receiving the intervention.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.