Young AdultsNCT06469749
Theory-based Social Media Intervention for Non-medical Use of Prescription Opioids in Young Adults
A study testing Theory-based and peer-led intervention on Instagram in people with Young Adults and Past-3-month Non-medical Use of Prescription Opioids, run by University of South Carolina at 1 site in United States.
Trial summary
Brief Summary The purposes of this study are to develop and implement a peer-led intervention program on Instagram for promoting prescription opioid use management and fostering psychosocial skills among young adults who engage in non-medical use of prescription opioids in the United State. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Young Adults, Past-3-month Non-medical Use of Prescription Opioids, Without Substance Use Disorders
- What is being tested?
- Theory-based and peer-led intervention on Instagram
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-25 years
- from the U.S.
- can read and speak English
- engage in non-medical use of prescription opioids in the past three months: taking prescription opioids without a doctor's prescription/taking more doses of prescription opioids than what a prescription allows/using prescription opioid for reasons other than a medical purpose
- use Instagram three times a week or more in the past three months
Who cannot join
- receiving substance use interventions in the past three months
- are diagnosed with substance use disorders
- are not proficient in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaoming Li contact
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
Cheuk Chi Tam, Ph.D., 803-777-6883, ctam@mailbox.sc.edu
Cheuk Chi Tam, Ph.D.
About this study
Brief Summary
The purposes of this study are to develop and implement a peer-led intervention program on Instagram for promoting prescription opioid use management and fostering psychosocial skills among young adults who engage in non-medical use of prescription opioids in the United State. The specific aims of the study include:
Read more
(1) To implement and test the feasibility of the 12-week peer-led intervention modules on Instagram among young adults who are randomly assigned to either receive the intervention (intervention group) or not receive the intervention (control group)
Participants who are assigned to the intervention group will be paired with a peer leader and attend to peer-guided interactive modules on Instagram over 12 weeks. They will complete an online survey at 1st week and 12th week, as well as brief evening surveys every two days during the intervention. The control group will not take part in intervention activities but will complete an online survey at 1st week and 12th week.
Read the detailed description
Non-medical use of prescription opioids (NMUPO) is a timely and significant public health issue in the United States (US). Young adults are the key population vulnerable to NMUPO. Existing literature indicates that NMUPO in young adults is influenced by a robust array of psychosocial factors. Tailored interventions guided by a psychosocial theory, such as the information-motivation-behavioral skills (IMB) model, are urgently needed for addressing NMUPO in young adults. One innovative approach is to reach out to and deliver psychosocial interventions to young adults via social media technology, yet limited efforts have sought to develop such interventions for NMUPO among young adults. Thus the scientific objective of this study is to develop a peer-led social media intervention designed to reduce NMUPO among young adults. The objective of this study is to obtain intensive mentored training essential to improving the theoretical and practical expertise needed to develop innovative and implementable peer-led psychosocial interventions for NMUPO in high-risk populations. This study aims to develop a theory-based social media intervention and evaluate the feasibility, acceptability, usability, and preliminary efficacy on NMUPO reduction and psychosocial changes of the intervention through a 12-week pilot randomized controlled trial among 70 NMUPO engaging young adults (35 for intervention and 35 for control) via pre-test, 12-week ecological momentary assessment (during the intervention), and post-tests (12-month follow-ups). The intervention development will be informed by formative findings on psychosocial aspects of NMUPO in young adults. This project will contribute to future largescale and fully-powered psychosocial interventions for NMUPO among young adults or other high-risk populations using innovative technology that can address challenges in traditional substance use interventions.
- Conditions
- Young Adults, Past-3-month Non-medical Use of Prescription Opioids, Without Substance Use Disorders, Social Media Users
- Being tested
- Theory-based and peer-led intervention on Instagram
- Keywords
- opioids, Young Adults, Information-Motivation-Behavioral skills Model, Psychosocial factors, social media, Resilience, Mental health, Peer role model
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theory-based and peer-led intervention on InstagramBehavioural
Also called Information-motivation-behavioral skills model guided intervention, peer-led intervention, social media intervention, psychosocial intervention
A pilot randomized controlled trial of the 12-weeks social media intervention for non-medical use of prescription opioids (NMUPO) among young adults will be developed upon the formative research (Aim 1) grounded in the information-motivation-behavioral-skills (IMB) model. Intervention will be delivered by peer leaders, who are well-trained recovery coaches, via private groups on Instagram. Intervention contents will be tailored to psychosocial factors contributing to NMUPO.
Intervention components. Incorporating Instagram functions, the intervention is planned to include four intervention modules: (1) NMUPO knowledge module, (2) self-care module, (3) virtual goal setting/monitoring module, (4) peer support module. Intervention will be delivered by peer leaders (assisted by clinical psychology trainees a) via private groups operated by their Instagram accounts. The process will be overseen by certificated experts in clinical psychology and addiction treatment.
| Study group | Role | What they receive |
|---|---|---|
| 12-week peer-led intervention group on Instagram | Experimental | Participants in the intervention group will receive 12-week peer-led intervention interactive modules on Instagram. Receives: Behavioral: Theory-based and peer-led intervention on Instagram |
| Control group | No intervention | Participants in the control group will not engage in any intervention activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement
Paradata (e.g., frequencies of shares, comments, likes, and posts) on particular intervention contents)
Measured: Once in every two days for 12 weeks
Acceptability
Likert items that rate how helpful the particular intervention module is (1 = not at all to 5 = extremely). This will be measured in the ecological momentary assessment surveys.
Measured: Once in every two days for 12 weeks
Feasibility of the intervention
Feasibility will be assessed via the post-intervention interviews in terms of the reactions to the contents, format, concepts, and visual presentation of modules.
Measured: Immediately at 12-week post-intervention
Usability
Usability will be measured using the Usefulness, Satisfaction, and Ease of use-Lite (USE-Lite) questionnaire which assesses perceived usefulness and satisfaction for specific intervention modules. This will be measured in the ecological momentary assessment surveys. The scale comprises a total of 15 items, with 8 items for usefulness and 7 for satisfaction. Items are rated on a 7-point scale (1=strong disagree to 7=strong agree). The sum score for each component will be generated, with a higher score indicating a greater level of usefulness (ranging from 8 to 56) or satisfaction (ranging from 7 to 49).
Measured: Once in every two days for 12 weeks
Dose
Guided by dose operationalization for mHealth intervention, dose of intervention will be collected in three domains: (1)intervention actions (if viewing a post); (2) participant actions (if practicing a skill/completing an assignment); (3) behavioral target actions (if adopting skills outside of the intervention). This will be measured in the ecological momentary assessment surveys.
Measured: Once in every two days for 12 weeks
Non-medical use of prescription opioids
Any behaviors to indicate (1) taking a prescription opioid without a prescription; (2) taking prescription opioids more doses than what a prescription allows; (3) using prescription opioids for reasons other than a medical purpose. The frequency of such behaviors in the past 30 days will be assessed using the Tobacco, Alcohol, Prescription medication, and other Substance use Tool (TAPS) tool.
Measured: Immediately at pre-intervention and 12-week post-intervention
Secondary outcomes (8)
Outcome expectancies
Beliefs on positive or negative consequences of engaging in non-medical use of prescription opioids. This will be assessed using a scale adapted from the Behaviors, Expectancies, Attitudes and College Health Questionnaire (BEACH-Q). A total of 50 Items will be scored on a five-point Likert-type scale ranging from 0 (Not at all) to 4 (Very often or always) with higher sum scores standing for the greater level of expectancies. The sum scores range from 0 to 200. The scale consists of eight dimensions related to specific expectancies of opioids, including pain reduction, tension reduction, academic preference, emotion enhancement, social enhancement, guilt and dependence, cognitive impairment, and physical discomfort.
Measured: immediately at pre-intervention and 12-week post-intervention
Risk perception
Perceived vulnerability and severity of engaging in non-medical use of prescription opioids. This will be assessed using the Perceived Risk Scale for Prescription Drug Abuse. This scale includes 5 items on a four-option scale (1="strongly disagree" to 4 = "strongly agree". The sum score will be generated (range = 5 to 20), with higher score indicating a greater level of perception risk for non-medical use of prescription opioids.
Measured: immediately at pre-intervention and 12-week post-intervention
Action self-efficacy and coping self-efficacy
Perceived control on making actions to stop/reduce NMUPO or confidence on coping with barriers against the actions. This will be assessed using an adapted version of Self-Efficacy Scale. A total of six Items will be rated on a 5-point Likert scale (1 = strong disagree, 5 = strongly agree) and can be organized into 2 subscales (coping self-efficacy and action self-efficacy) with 3 items each. The maximum obtainable score for each subscale will be 15 points, and the minimum obtainable score is 3 points. The sum scores will be generated for each subscale, with higher scores indicating greater levels of self-efficacy.
Measured: immediately at pre-intervention and 12-week post-intervention
Depression
Experiences of depressive symptoms in the past two weeks. This will be assessed using the Patient Health Questionnaire-9 (PHQ-9). Nine items will be rated on a 4-option scale (0 = not at all, 3 = nearly every day) with a minimum possible score of 0 and a maximum score of 27. The sum score will be generated, with a higher score indicating a higher level of depression.
Measured: immediately at pre-intervention and 12-week post-intervention
Anxiety
Anxious symptom experiences in the past two weeks. This will be assessed using the General Anxiety Disorder-7 (GAD 7). Seven items will be rated on a 4-option scale (0 = not at all, 3 = nearly every day) with a minimum possible score of 0 and a maximum score of 21. The sum score will be generated, with a higher score indicating a higher level of anxiety.
Measured: immediately at pre-intervention and 12-week post-intervention
Resilience
Personal capacities in response to stress such as tenacity, tolerance of negative affect, positive acceptance of change, and positive view of adversities. This will be assessed using the Connor-Davidson resilience scale (CD-RISD). The scale comprises of 25 items, with each rated on a 5-point scale (0 to 4). The sum score will be generated, with a higher score indicating a greater level of resilience. The possible sum score ranges from 0 to 100.
Measured: immediately at pre-intervention and 12-week post-intervention
Other substance use
Engagement in the use of alcohol, illicit drugs, and cigarette in the past three months. This will be assessed using the NIDA-Modified Alcohol, Smoking and Substance Involvement Screening (NIDA-ASSIST). The scale includes 12 dichotomous items (0= No, 1 = Yes) asking if a participant has engaged in using or misusing any of 12 individual substances.
Measured: immediately at pre-intervention and 12-week post-intervention
Non-medical use of prescription opioids knowledge
Information about non-medical use of prescription opioids and relevant topics, such as misconceptions, the role of fentanyl, naloxone, and Xyalazine. This scale will be developed according to the measure in POP4Teens and the formative study. This scale is proposed to include 15 statements related to opioids or non-medical use of prescription opioids. Participant will be asked to determine if a statement is true or not (0 = False, 1 = True). Responses will then be rated by the research team, with higher scores indicating better knowledge of non-medical use of prescription opioids.
Measured: immediately at pre-intervention and 12-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Young AdultsStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will be a pilot trial, conducted through a Randomized controlled trial design.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Cheuk Chi Tam, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469749
- Sponsor's protocol ID
- Pro00135306
- Other IDs
- 1K01DA058768-01A1
- Status last verified
- Feb 2026
- First submitted
- 11 Jun 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tam CC, Young SD, Harrison S, Li X, Litwin AH. Theory-Based Social Media Intervention for Nonmedical Use of Prescription Opioids in Young Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 26;14:e65847. doi: 10.2196/65847.
PubMed 40139213
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory-based Social Media Intervention for Non-medical Use of Prescription Opioids in Young Adults
- ClinicalTrials.gov ID
- NCT06469749
- Acronym / sponsor ID
- Pro00135306
- Conditions
- Young Adults, Past-3-month Non-medical Use of Prescription Opioids, Without Substance Use Disorders, Social Media Users
- Keywords
- opioids, Young Adults, Information-Motivation-Behavioral skills Model, Psychosocial factors, social media, Resilience, Mental health, Peer role model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 24 Jun 2024 (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.
Brief Summary
The purposes of this study are to develop and implement a peer-led intervention program on Instagram for promoting prescription opioid use management and fostering psychosocial skills among young adults who engage in non-medical use of prescription opioids in the United State. The specific aims of the study include:
(1) To implement and test the feasibility of the 12-week peer-led intervention modules on Instagram among young adults who are randomly assigned to either receive the intervention (intervention group) or not receive the intervention (control group)
Participants who are assigned to the intervention group will be paired with a peer leader and attend to peer-guided interactive modules on Instagram over 12 weeks. They will complete an online survey at 1st week and 12th week, as well as brief evening surveys every two days during the intervention. The control group will not take part in intervention activities but will complete an online survey at 1st week and 12th week.
Detailed description
Non-medical use of prescription opioids (NMUPO) is a timely and significant public health issue in the United States (US). Young adults are the key population vulnerable to NMUPO. Existing literature indicates that NMUPO in young adults is influenced by a robust array of psychosocial factors. Tailored interventions guided by a psychosocial theory, such as the information-motivation-behavioral skills (IMB) model, are urgently needed for addressing NMUPO in young adults. One innovative approach is to reach out to and deliver psychosocial interventions to young adults via social media technology, yet limited efforts have sought to develop such interventions for NMUPO among young adults. Thus the scientific objective of this study is to develop a peer-led social media intervention designed to reduce NMUPO among young adults. The objective of this study is to obtain intensive mentored training essential to improving the theoretical and practical expertise needed to develop innovative and implementable peer-led psychosocial interventions for NMUPO in high-risk populations. This study aims to develop a theory-based social media intervention and evaluate the feasibility, acceptability, usability, and preliminary efficacy on NMUPO reduction and psychosocial changes of the intervention through a 12-week pilot randomized controlled trial among 70 NMUPO engaging young adults (35 for intervention and 35 for control) via pre-test, 12-week ecological momentary assessment (during the intervention), and post-tests (12-month follow-ups). The intervention development will be informed by formative findings on psychosocial aspects of NMUPO in young adults. This project will contribute to future largescale and fully-powered psychosocial interventions for NMUPO among young adults or other high-risk populations using innovative technology that can address challenges in traditional substance use interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will be a pilot trial, conducted through a Randomized controlled trial design.
| Arm | Type | Receives |
|---|---|---|
| 12-week peer-led intervention group on Instagram | Experimental | Behavioral: Theory-based and peer-led intervention on InstagramParticipants in the intervention group will receive 12-week peer-led intervention interactive modules on Instagram. |
| Control group | No intervention | –Participants in the control group will not engage in any intervention activities. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 18-25 years
- from the U.S.
- can read and speak English
- engage in non-medical use of prescription opioids in the past three months: taking prescription opioids without a doctor's prescription/taking more doses of prescription opioids than what a prescription allows/using prescription opioid for reasons other than a medical purpose
- use Instagram three times a week or more in the past three months
Key exclusion criteria (3 listed)
- receiving substance use interventions in the past three months
- are diagnosed with substance use disorders
- are not proficient in English
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 |
|---|---|---|
| Theory-based and peer-led intervention on InstagramAlso: Information-motivation-behavioral skills model guided intervention, peer-led intervention, social media intervention, psychosocial interventionA pilot randomized controlled trial of the 12-weeks social media intervention for non-medical use of prescription opioids (NMUPO) among young adults will be developed upon the formative research (Aim 1) grounded in the information-motivation-behavioral-skills (IMB) model. Intervention will be delivered by peer leaders, who are well-trained recovery coaches, via private groups on Instagram. Intervention contents will be tailored to psychosocial factors contributing to NMUPO. Intervention components. Incorporating Instagram functions, the intervention is planned to include four intervention modules: (1) NMUPO knowledge module, (2) self-care module, (3) virtual goal setting/monitoring module, (4) peer support module. Intervention will be delivered by peer leaders (assisted by clinical psychology trainees a) via private groups operated by their Instagram accounts. The process will be overseen by certificated experts in clinical psychology and addiction treatment. | Behavioural | 12-week peer-led intervention group on Instagram |
Primary outcome
Engagement
Time frame: Once in every two days for 12 weeks
Paradata (e.g., frequencies of shares, comments, likes, and posts) on particular intervention contents)
Acceptability
Time frame: Once in every two days for 12 weeks
Likert items that rate how helpful the particular intervention module is (1 = not at all to 5 = extremely). This will be measured in the ecological momentary assessment surveys.
Feasibility of the intervention
Time frame: Immediately at 12-week post-intervention
Feasibility will be assessed via the post-intervention interviews in terms of the reactions to the contents, format, concepts, and visual presentation of modules.
Usability
Time frame: Once in every two days for 12 weeks
Usability will be measured using the Usefulness, Satisfaction, and Ease of use-Lite (USE-Lite) questionnaire which assesses perceived usefulness and satisfaction for specific intervention modules. This will be measured in the ecological momentary assessment surveys. The scale comprises a total of 15 items, with 8 items for usefulness and 7 for satisfaction. Items are rated on a 7-point scale (1=strong disagree to 7=strong agree). The sum score for each component will be generated, with a higher score indicating a greater level of usefulness (ranging from 8 to 56) or satisfaction (ranging from 7 to 49).
Dose
Time frame: Once in every two days for 12 weeks
Guided by dose operationalization for mHealth intervention, dose of intervention will be collected in three domains: (1)intervention actions (if viewing a post); (2) participant actions (if practicing a skill/completing an assignment); (3) behavioral target actions (if adopting skills outside of the intervention). This will be measured in the ecological momentary assessment surveys.
Non-medical use of prescription opioids
Time frame: Immediately at pre-intervention and 12-week post-intervention
Any behaviors to indicate (1) taking a prescription opioid without a prescription; (2) taking prescription opioids more doses than what a prescription allows; (3) using prescription opioids for reasons other than a medical purpose. The frequency of such behaviors in the past 30 days will be assessed using the Tobacco, Alcohol, Prescription medication, and other Substance use Tool (TAPS) tool.
8 secondary outcomes
Outcome expectancies
Time frame: immediately at pre-intervention and 12-week post-intervention
Risk perception
Time frame: immediately at pre-intervention and 12-week post-intervention
Action self-efficacy and coping self-efficacy
Time frame: immediately at pre-intervention and 12-week post-intervention
Depression
Time frame: immediately at pre-intervention and 12-week post-intervention
Anxiety
Time frame: immediately at pre-intervention and 12-week post-intervention
Resilience
Time frame: immediately at pre-intervention and 12-week post-intervention
Other substance use
Time frame: immediately at pre-intervention and 12-week post-intervention
Non-medical use of prescription opioids knowledge
Time frame: immediately at pre-intervention and 12-week post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Derived from this study: PubMed 40139213Tam CC, Young SD, Harrison S, Li X, Litwin AH. Theory-Based Social Media Intervention for Nonmedical Use of Prescription Opioids in Young Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Mar 26;14:e65847. doi: 10.2196/65847.
- Individual participant dataSharing planned: No
Related trials for Young Adults
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
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.
Xiaoming Li contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theory-based and peer-led intervention on Instagram in people with Young Adults and Past-3-month Non-medical Use of Prescription Opioids, run by University of South Carolina 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 23 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheuk Chi Tam, Ph.D. (803-777-6883, ctam@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement (time frame: Once in every two days for 12 weeks). The study lists 6 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 NCT06469749, which also lists 1 linked publication.
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 23 Feb 2026.