Stigma, SocialNCT06281548
Feasibility and Acceptability of a Stigma Text Message Intervention for People Who Use Drugs
A study testing RESTART in people with Stigma, Social and Substance Use, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stigma, Social, Substance Use
- What is being tested?
- RESTART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2024to 14 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 and older at enrollment
- Residing in Scioto County, Ohio at time of enrollment
- Able to speak and read English
- Reliable daily access to smart phone with a data plan capable of sending and receiving text messages during the intervention period (4 weeks)
- Self-reported past 30-day use of illicit opioids (e.g., heroin, fentanyl), prescription opioids not as prescribed (e.g., oxycodone, buprenorphine), methamphetamine, or cocaine
- Willing to provide informed consent
Who cannot join
- Unable to be consented due to cognitive impairment
- Planning to move out of the study area during the study period
- Unwilling or unable to comply with protocol requirements
- Currently incarcerated in a correctional facility
Trial locations and contacts
1 site in 1 country.
United States1 site
SHRPS Syringe Service Program
Portsmouth, Ohio, 45662
About this study
Official title: Determining the Feasibility and Acceptability of a Novel Stigma Resistance Text Message Intervention for People Who Use Drugs
Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use.
This study is a single-group pilot trial to determine whether the intervention is feasible and acceptable to participants. All participants will receive the intervention. The primary outcomes are changes in stigma resistance and self-stigma from baseline to 4-week follow-up using self-report. Implementation and process outcomes will be measured to inform future intervention refinement.
Read the detailed description
Nearly 850,000 Americans have died from overdose in the past two decades, and mortality reached an all-time high during the COVID-19 pandemic. Substance use disorders (SUD) are more highly stigmatized than other health conditions (e.g., HIV, mental illness). SUD stigma prevents uptake of treatment and harm reduction among people who use drugs (PWUD), contributing to needless morbidity (e.g., infectious disease) and mortality (e.g., overdose), and explains in part why only 6.5% of Americans with SUD received past year treatment. Though key federal agencies have identified stigma as a strategic priority in the epidemic, little is known about how to conceptualize and address SUD stigma compared with other health conditions.
Strategies to address SUD self-stigma, in particular, are severely lacking. Self-stigma manifests in PWUD as internalized stereotypes and fear of experienced stigma, leading to the so-called 'why try' phenomenon in which the stigmatized are disempowered from pursuing life goals. SUD self-stigma is associated with numerous psychosocial outcomes including depression, anxiety, diminished quality of life, maladaptive coping and leads to delays in treatment and harm reduction seeking and retention. To date, SUD interventions have overwhelmingly targeted public stigma such as treatment provider attitudes, while there is a remarkable dearth of evidence-based interventions for addressing self-stigma in PWUD.
Stigma resistance, a coping strategy that promotes resilience through empowerment and positive identity formation, is a promising approach to reducing self-stigma. Stigma resistance is associated with multiple psychosocial outcomes, including reductions in self-stigma and improvements in quality of life, self-efficacy, hope, help-seeking, and recovery. Stigma resistance includes both cognitive and behavioral strategies, such as catching and challenging stigmatizing thoughts, forming positive alternative identities, and empowering oneself through learning about substance use. These strategies align directly with techniques used in the HIV/AIDS and mental illness self-stigma intervention literature. Stigma resistance thus serves as an ideal conceptual framework and menu of strategies for the present study's self-stigma reduction intervention.
Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use.
The specific aim of this study is to evaluate feasibility, acceptability, and preliminary effectiveness of the text message intervention to increase stigma resistance and reduce self-stigma. We will conduct a single-group pilot trial of the intervention among 30 rural Ohio PWUD in active use and collect quantitative and qualitative data at baseline and four-week follow-up.
- Conditions
- Stigma, Social, Substance Use
- Being tested
- RESTART
- Keywords
- people who use drugs, rural health, stigma, behavioral interventions, mobile health, mental health
- Medical subject headings
- Social Stigma, Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESTARTBehavioural
Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants in the intervention arm will receive 56 text messages over 4-weeks. Receives: Behavioral: RESTART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stigma Resistance Scale (SRS) Score
This is a 20-item Likert-type scale that assesses participants' capacity to resist stigma in five domains (self-other differentiation, personal identity, personal cognitions, peer stigma resistance, public stigma resistance).
All items are scored such that higher scores reflect greater stigma resistance. Total scale score ranges from 20-100.
Measured: Baseline, 4-week follow-up visit
Change in Substance Abuse Self-Stigma Scale (SASSS) Score
This is a 40-item Likert-type scale that assesses degree to which participants internalize judgment for their substance use and fear experiencing stigma from others. The scale includes four subscales: self-devaluation (8 items), fear of enacted stigma (9 items), stigma avoidance (13 items), and values disengagement (10 items).
Total scale score ranges from 40-200, where higher scores reflect higher levels of self-stigma. The self-devaluation, fear of enacted stigma, and stigma avoidance subscales are scored normally, while the values disengagement subscale is reverse scored.
Measured: Baseline, 4-week follow-up visit
Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment)
Percentage of potential participants screened for study eligibility who are eligible for participation.
Measured: From first recruitment visit to last recruitment visit (up to 4 weeks)
Percentage of Prospective Participants Recruited Into Study (Feasibility - Enrollment)
Percentage of potential participants screened for study eligibility who enroll in the study.
Measured: From first recruitment visit to last enrollment visit (up to 4 weeks)
Time to Sample Saturation (Feasibility - Recruitment)
Time in days to enroll the full sample size (n=30), starting from the first recruitment visit
Measured: From first recruitment visit to last enrollment visit (up to 4 weeks)
Percentage of Participants Retained in Study (Feasibility - Retention)
Percentage of participants enrolled in the study who are retained through study completion (i.e., complete 4-week follow-up survey).
Measured: From first enrollment visit to study completion date (up to 8 weeks)
Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User)
This is a 16-item Likert-type questionnaire designed to assess acceptability of the intervention from the participants' perspective along the eight dimensions of the Theoretical Framework of Acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy, and general acceptability.
Total score ranges from 16-64, with higher scores indicating greater acceptability of the intervention.
Measured: 4-week follow-up visit
Percentage of Participants With High Text Message Frequency (Feasibility - User)
Percentage of participants who report "every day" to the 5-point Likert-type survey question "Before the start of this program, how often did you send or receive text messages?"
Measured: 4-week follow-up visit
Percentage of Participants With High Text Messaging Comfort (Feasibility - User)
Percentage of participants who report "very comfortable" or "comfortable" to the 5-point Likert-type survey question "Before the start of this program, how comfortable were you with sending or receiving text messages?"
Measured: 4-week follow-up visit
Percentage of Participants With Cell Phone Device Challenges (Feasibility - User)
Percentage of participants who respond "yes" to the binary survey question "Between the start of the program and now, did you experience any challenges or changes with your phone (e.g., lost, broken) that prevented you from receiving or reading text messages?"
Measured: 4-week follow-up visit
Percentage of Participants With Cell Phone Plan Challenges (Feasibility - User)
Percentage of participants who respond "yes" to the binary survey question "Between the start of the program and now, did you experience any challenges or changes with your phone number or phone plan (e.g., changed number, ran out of minutes) that prevented you from receiving or reading text messages?"
Measured: 4-week follow-up visit
Percentage of Participants Who Read Messages Daily (Feasibility - User)
Percentage of participants who respond "As soon as I saw them" or "Later that day" to the 5-point Likert-type survey question "On average, when would you read the text message you received?"
Measured: 4-week follow-up visit
Secondary outcomes (2)
Change in Adult Dispositional Hope Scale Score
This is a 12-item Likert-type scale that assesses participants' hope (i.e., positive attitude toward the future).
Total scale score ranges from 12-96, where higher scores indicate greater hope.
Measured: Baseline, 4-week follow-up visit
Change in Rosenberg Self-Esteem Scale Score
This is a 10-item Likert-type scale that assesses participants' self-esteem.
Total scale score range from 10-40, where higher scores indicate greater self-esteem.
Measured: Baseline, 4-week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start29 Feb 2024
- Primary completion14 Apr 2024
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stigma, SocialStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Adams L Sibley, MPH, Principal investigator, Doctoral Candidate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281548
- Sponsor's protocol ID
- 23-2937
- Other IDs
- 1F31DA058452
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification, may be provided to researchers who provide a methodologically sound proposal to achieve the proposal's aims.
Publications
Sibley AL, Muessig KE, Noar SM, Gottfredson O'Shea N, Miller WC, Go VF. Promoting substance use stigma resistance through an automated text message intervention (project RESTART): Outcomes of a pilot feasibility trial. J Subst Use Addict Treat. 2025 May;172:209671. doi: 10.1016/j.josat.2025.209671. Epub 2025 Mar 6.
PubMed 40057241Sibley AL, Noar SM, Muessig KE, O'Shea NG, Paquette CE, Spears AG, Miller WC, Go VF. An Automated Text Messaging Intervention to Reduce Substance Use Self-Stigma (Project RESTART): Protocol for a Feasibility and Acceptability Pilot Study. JMIR Res Protoc. 2024 Aug 9;13:e59224. doi: 10.2196/59224.
PubMed 39121478
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Feasibility and Acceptability of a Novel Stigma Resistance Text Message Intervention for People Who Use Drugs
- ClinicalTrials.gov ID
- NCT06281548
- Acronym / sponsor ID
- 23-2937
- Conditions
- Stigma, Social, Substance Use
- Keywords
- people who use drugs, rural health, stigma, behavioral interventions, mobile health, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 14 Apr 2024 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use.
This study is a single-group pilot trial to determine whether the intervention is feasible and acceptable to participants. All participants will receive the intervention. The primary outcomes are changes in stigma resistance and self-stigma from baseline to 4-week follow-up using self-report. Implementation and process outcomes will be measured to inform future intervention refinement.
Detailed description
Nearly 850,000 Americans have died from overdose in the past two decades, and mortality reached an all-time high during the COVID-19 pandemic. Substance use disorders (SUD) are more highly stigmatized than other health conditions (e.g., HIV, mental illness). SUD stigma prevents uptake of treatment and harm reduction among people who use drugs (PWUD), contributing to needless morbidity (e.g., infectious disease) and mortality (e.g., overdose), and explains in part why only 6.5% of Americans with SUD received past year treatment. Though key federal agencies have identified stigma as a strategic priority in the epidemic, little is known about how to conceptualize and address SUD stigma compared with other health conditions.
Strategies to address SUD self-stigma, in particular, are severely lacking. Self-stigma manifests in PWUD as internalized stereotypes and fear of experienced stigma, leading to the so-called 'why try' phenomenon in which the stigmatized are disempowered from pursuing life goals. SUD self-stigma is associated with numerous psychosocial outcomes including depression, anxiety, diminished quality of life, maladaptive coping and leads to delays in treatment and harm reduction seeking and retention. To date, SUD interventions have overwhelmingly targeted public stigma such as treatment provider attitudes, while there is a remarkable dearth of evidence-based interventions for addressing self-stigma in PWUD.
Stigma resistance, a coping strategy that promotes resilience through empowerment and positive identity formation, is a promising approach to reducing self-stigma. Stigma resistance is associated with multiple psychosocial outcomes, including reductions in self-stigma and improvements in quality of life, self-efficacy, hope, help-seeking, and recovery. Stigma resistance includes both cognitive and behavioral strategies, such as catching and challenging stigmatizing thoughts, forming positive alternative identities, and empowering oneself through learning about substance use. These strategies align directly with techniques used in the HIV/AIDS and mental illness self-stigma intervention literature. Stigma resistance thus serves as an ideal conceptual framework and menu of strategies for the present study's self-stigma reduction intervention.
Project RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages are designed to address four components of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use.
The specific aim of this study is to evaluate feasibility, acceptability, and preliminary effectiveness of the text message intervention to increase stigma resistance and reduce self-stigma. We will conduct a single-group pilot trial of the intervention among 30 rural Ohio PWUD in active use and collect quantitative and qualitative data at baseline and four-week follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: RESTARTParticipants in the intervention arm will receive 56 text messages over 4-weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18 and older at enrollment
- Residing in Scioto County, Ohio at time of enrollment
- Able to speak and read English
- Reliable daily access to smart phone with a data plan capable of sending and receiving text messages during the intervention period (4 weeks)
- Self-reported past 30-day use of illicit opioids (e.g., heroin, fentanyl), prescription opioids not as prescribed (e.g., oxycodone, buprenorphine), methamphetamine, or cocaine
Key exclusion criteria (4 listed)
- Unable to be consented due to cognitive impairment
- Planning to move out of the study area during the study period
- Unwilling or unable to comply with protocol requirements
- Currently incarcerated in a correctional facility
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 |
|---|---|---|
| RESTARTProject RESTART (Resisting STigma And Revaluating your Thoughts) is a theory-informed, 4-week automated text message intervention to address self-stigma in people who use drugs. The intervention delivers two daily messages to participants for four weeks (56 messages total). Messages address the four components of the personal level of Stigma Resistance Theory: Not believing stigma/catching and challenging stigmatizing thoughts; empowering oneself through learning about substance use and one's own recovery; maintaining one's recovery and proving stigma wrong; and developing a meaningful identity and purpose apart from one's substance use. Content is informed by evidence-based psychotherapeutic approaches (e.g., Acceptance and Commitment Therapy) and health communication theory (e.g., Elaboration Likelihood Model). Messages include psychoeducation about substance use and stigma, coping advice, and suggestions for how to set personal goals, identify values, and build self-esteem. | Behavioural | Intervention arm |
Primary outcome
Change in Stigma Resistance Scale (SRS) Score
Time frame: Baseline, 4-week follow-up visit
This is a 20-item Likert-type scale that assesses participants' capacity to resist stigma in five domains (self-other differentiation, personal identity, personal cognitions, peer stigma resistance, public stigma resistance). All items are scored such that higher scores reflect greater stigma resistance. Total scale score ranges from 20-100.
Change in Substance Abuse Self-Stigma Scale (SASSS) Score
Time frame: Baseline, 4-week follow-up visit
This is a 40-item Likert-type scale that assesses degree to which participants internalize judgment for their substance use and fear experiencing stigma from others. The scale includes four subscales: self-devaluation (8 items), fear of enacted stigma (9 items), stigma avoidance (13 items), and values disengagement (10 items). Total scale score ranges from 40-200, where higher scores reflect higher levels of self-stigma. The self-devaluation, fear of enacted stigma, and stigma avoidance subscales are scored normally, while the values disengagement subscale is reverse scored.
Percentage of Prospective Participants Eligible for Participation (Feasibility - Recruitment)
Time frame: From first recruitment visit to last recruitment visit (up to 4 weeks)
Percentage of potential participants screened for study eligibility who are eligible for participation.
Percentage of Prospective Participants Recruited Into Study (Feasibility - Enrollment)
Time frame: From first recruitment visit to last enrollment visit (up to 4 weeks)
Percentage of potential participants screened for study eligibility who enroll in the study.
Time to Sample Saturation (Feasibility - Recruitment)
Time frame: From first recruitment visit to last enrollment visit (up to 4 weeks)
Time in days to enroll the full sample size (n=30), starting from the first recruitment visit
Percentage of Participants Retained in Study (Feasibility - Retention)
Time frame: From first enrollment visit to study completion date (up to 8 weeks)
Percentage of participants enrolled in the study who are retained through study completion (i.e., complete 4-week follow-up survey).
Theoretical Framework of Acceptability (TFA) User Questionnaire Score (Acceptability - User)
Time frame: 4-week follow-up visit
This is a 16-item Likert-type questionnaire designed to assess acceptability of the intervention from the participants' perspective along the eight dimensions of the Theoretical Framework of Acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy, and general acceptability. Total score ranges from 16-64, with higher scores indicating greater acceptability of the intervention.
Percentage of Participants With High Text Message Frequency (Feasibility - User)
Time frame: 4-week follow-up visit
Percentage of participants who report "every day" to the 5-point Likert-type survey question "Before the start of this program, how often did you send or receive text messages?"
Percentage of Participants With High Text Messaging Comfort (Feasibility - User)
Time frame: 4-week follow-up visit
Percentage of participants who report "very comfortable" or "comfortable" to the 5-point Likert-type survey question "Before the start of this program, how comfortable were you with sending or receiving text messages?"
Percentage of Participants With Cell Phone Device Challenges (Feasibility - User)
Time frame: 4-week follow-up visit
Percentage of participants who respond "yes" to the binary survey question "Between the start of the program and now, did you experience any challenges or changes with your phone (e.g., lost, broken) that prevented you from receiving or reading text messages?"
Percentage of Participants With Cell Phone Plan Challenges (Feasibility - User)
Time frame: 4-week follow-up visit
Percentage of participants who respond "yes" to the binary survey question "Between the start of the program and now, did you experience any challenges or changes with your phone number or phone plan (e.g., changed number, ran out of minutes) that prevented you from receiving or reading text messages?"
Percentage of Participants Who Read Messages Daily (Feasibility - User)
Time frame: 4-week follow-up visit
Percentage of participants who respond "As soon as I saw them" or "Later that day" to the 5-point Likert-type survey question "On average, when would you read the text message you received?"
2 secondary outcomes
Change in Adult Dispositional Hope Scale Score
Time frame: Baseline, 4-week follow-up visit
Change in Rosenberg Self-Esteem Scale Score
Time frame: Baseline, 4-week follow-up visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40057241Sibley AL, Muessig KE, Noar SM, Gottfredson O'Shea N, Miller WC, Go VF. Promoting substance use stigma resistance through an automated text message intervention (project RESTART): Outcomes of a pilot feasibility trial. J Subst Use Addict Treat. 2025 May;172:209671. doi: 10.1016/j.josat.2025.209671. Epub 2025 Mar 6.
- Derived from this study: PubMed 39121478Sibley AL, Noar SM, Muessig KE, O'Shea NG, Paquette CE, Spears AG, Miller WC, Go VF. An Automated Text Messaging Intervention to Reduce Substance Use Self-Stigma (Project RESTART): Protocol for a Feasibility and Acceptability Pilot Study. JMIR Res Protoc. 2024 Aug 9;13:e59224. doi: 10.2196/59224.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification, may be provided to researchers who provide a methodologically sound proposal to achieve the proposal's aims.
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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.
Adams L Sibley, MPH principal investigator
Doctoral Candidate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESTART in people with Stigma, Social and Substance Use, run by University of North Carolina, Chapel Hill 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 6 inclusion and 4 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 10 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Stigma Resistance Scale (SRS) Score (time frame: Baseline, 4-week follow-up visit). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06281548, which also lists 2 linked publications.
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 10 Jul 2024.