SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693416
• Other study ID #: 20-07852
• Secondary ID: 3R61AT010604-01S
• Status: Completed
• Phase: Phase 2
• Start date: March 8, 2021
• Est. completion date: August 30, 2021

Study information

• Verified date: March 2023
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Opioid Use
• Opioid-Related Disorders
• Opioid-use Disorder
• Stigma, Social
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• Intrapersonal Stigma Reduction
Brief intervention for stigma reduction
• Interpersonal Stigma Reduction
Brief intervention for support persons of intrapersonal intervention participants.

Locations

Country	Name	City	State
United States	University of Tennessee Health Science Center	Memphis	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
University of Tennessee	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Palamar JJ, Kiang MV, Halkitis PN. Development and psychometric evaluation of scales that assess stigma associated with illicit drug users. Subst Use Misuse. 2011;46(12):1457-67. doi: 10.3109/10826084.2011.596606. Epub 2011 Jul 18. — View Citation

Palamar JJ. An examination of beliefs and opinions about drug use in relation to personal stigmatization towards drug users. J Psychoactive Drugs. 2013 Nov-Dec;45(5):367-73. doi: 10.1080/02791072.2013.843044. — View Citation

Smith LR, Earnshaw VA, Copenhaver MM, Cunningham CO. Substance use stigma: Reliability and validity of a theory-based scale for substance-using populations. Drug Alcohol Depend. 2016 May 1;162:34-43. doi: 10.1016/j.drugalcdep.2016.02.019. Epub 2016 Feb 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enacted Stigma (Intrapersonal)	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.	Immediately before and 2-weeks post-intervention delivery
Primary	Anticipated Stigma (Intrapersonal)	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.	Immediately before and 2-weeks post-intervention delivery
Primary	Internalized Stigma (Intrapersonal)	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.	Immediately before and 2-weeks post-intervention delivery
Primary	Exposure to Drug Users Index Score	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).	Pre/post intervention (week 0)
Primary	Drug Use Stigmatization Scale Score	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.	Pre/post intervention (week 0: post-test immediately followed intervention)
Primary	Stigma of Drug Users Scale Score	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.	Pre/post intervention (week 0: post-test immediately followed intervention)
Secondary	Engagement in Treatment	Number of participants in intrapersonal arm who made an appointment for treatment after receiving the intervention.	2-weeks post-intervention

External Links

•   Lab website