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NCT04693416 · ClinicalTrials.gov registry record · Phase 2

SMART Trial: Intrapersonal and Interpersonal Stigma Reduction

A Phase 2 study, sponsored by University of Tennessee.

Completed
Registry status
Phase 2
Development phase
71
Enrollment target

NCT04693416: Completed Phase 2 study, sponsored by University of Tennessee.

NCT04693416 is a Phase 2 study that has completed, run by University of Tennessee. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04693416, a Phase 2 study, has completed, sponsored by University of Tennessee.

COMPLETED
Registry status
Phase 2
Development phase
71 participants
Enrollment target

Study 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.

Primary Outcome

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 sti

Interventions

  • OTHER Intrapersonal Stigma Reduction
  • OTHER Interpersonal Stigma Reduction

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2021-03-08
Est. Completion 2021-08-30
Phase Phase 2
University of Tennessee

96 total trials

What the finished NCT04693416 record still lists

NCT04693416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 2 interventions - of which Intrapersonal Stigma Reduction is the first listed.

NCT04693416 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04693416 about?

NCT04693416 is a clinical study titled "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 Am...

What is the current status of trial NCT04693416?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2021-03-08. Estimated completion is 2021-08-30.

What interventions are being tested in trial NCT04693416?

The interventions under investigation include: Intrapersonal Stigma Reduction (OTHER), Interpersonal Stigma Reduction (OTHER).

Who is sponsoring clinical trial NCT04693416?

This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04693416's enrollment target sits among peer trials

71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04693416, the US trial registry maintained by the National Library of Medicine. NCT04693416 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.