Opioid-use DisorderNCT05075330
SMART Trial: Community Stigma Reduction
A study testing Opioid Use Disorder Stigma Reduction in people with Opioid-use Disorder and Stigma, Social, run by Karen Derefinko, PhD at 1 site in United States.
Trial summary
The goal of this project is to engage community members from two low-income African American communities (N=200) in a survey study that assesses stigma toward those with Opioid Use Disorder (OUD). Those from the intervention community will be subject to a stigma reduction campaign via billboards. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder, Stigma, Social
- What is being tested?
- Opioid Use Disorder Stigma Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2021to 19 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identify as African American or Mixed race
- Reside in Frayser or Orange Mound Communities
- Access to telephone for follow-up assessment
Who cannot join
- Unable to understand consent procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
About this study
Official title: SMART Trial: Reducing Stigma Towards Opioid Use Disorder at the Community Level
The goal of this project is to engage community members from two low-income African American communities (N=200) in a survey study that assesses stigma toward those with Opioid Use Disorder (OUD). Those from the intervention community will be subject to a stigma reduction campaign via billboards. Those from the control community will not. Stigma will be re-assessed following the period of the campaign.
- Conditions
- Opioid-use Disorder, Stigma, Social
- Being tested
- Opioid Use Disorder Stigma Reduction
- Keywords
- stigma, opioid use disorder, community
- Medical subject headings
- Opioid-Related Disorders, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Use Disorder Stigma ReductionBehavioural
Billboards with destigmatizing language regarding opioid use disorder placed in the community.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants who live in the Orange Mound community of Memphis. Billboards targeting stigma reduction were posted in the community for one month. Receives: Behavioral: Opioid Use Disorder Stigma Reduction |
| Control | No intervention | Participants who live in the Frayser community of Memphis. No billboards (intervention) were placed here. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stigma score
Pre- and post-intervention stigma assessments using the Exposure to Drug Users Index, Drug Use Stigmatization Scale, and the Stigma of Drug Users Scale
Measured: Change from baseline stigma score at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start16 Jun 2021
- Primary completion19 Aug 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants assigned to intervention or control based on zip code of primary residence.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Derefinko, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Karen Derefinko, PhD, University of Tennessee
- Investigators
- Karen Derefinko, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075330
- Sponsor's protocol ID
- 21-08181-XP
- Status last verified
- Mar 2022
- First submitted
- 14 Sep 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART Trial: Reducing Stigma Towards Opioid Use Disorder at the Community Level
- ClinicalTrials.gov ID
- NCT05075330
- Acronym / sponsor ID
- 21-08181-XP
- Conditions
- Opioid-use Disorder, Stigma, Social
- Keywords
- stigma, opioid use disorder, community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Karen Derefinko, PhDUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to engage community members from two low-income African American communities (N=200) in a survey study that assesses stigma toward those with Opioid Use Disorder (OUD). Those from the intervention community will be subject to a stigma reduction campaign via billboards. Those from the control community will not. Stigma will be re-assessed following the period of the campaign.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants assigned to intervention or control based on zip code of primary residence.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Opioid Use Disorder Stigma ReductionParticipants who live in the Orange Mound community of Memphis. Billboards targeting stigma reduction were posted in the community for one month. |
| Control | No intervention | –Participants who live in the Frayser community of Memphis. No billboards (intervention) were placed here. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Identify as African American or Mixed race
- Reside in Frayser or Orange Mound Communities
- Access to telephone for follow-up assessment
Key exclusion criteria (1 listed)
- Unable to understand consent procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Use Disorder Stigma ReductionBillboards with destigmatizing language regarding opioid use disorder placed in the community. | Behavioural | Intervention |
Primary outcome
Stigma score
Time frame: Change from baseline stigma score at 8 weeks
Pre- and post-intervention stigma assessments using the Exposure to Drug Users Index, Drug Use Stigmatization Scale, and the Stigma of Drug Users Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Derefinko, PhD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Use Disorder Stigma Reduction in people with Opioid-use Disorder and Stigma, Social, run by Karen Derefinko, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stigma score (time frame: Change from baseline stigma score at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022; AzTrials last refreshed its copy on 27 Oct 2026.