Opiate-Related DisordersNCT06848504
MedSMA℞T Mobile ED
A study testing MedSMA℞T Mobile in people with Opiate-Related Disorders and Opiate Use Disorder, run by Olufunmilola Abraham at 3 sites in United States.
Trial summary
The goal of this clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. The main question it aims to answer is: Can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Opiate-Related Disorders, Opiate Use Disorder, Opioid
- What is being tested?
- MedSMA℞T Mobile
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2027to Dec 2027
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults who receive an opioid prescription from a study Emergency Department, AND
- who report having an adolescent, aged 12-18, living at home, AND
- who speak and understand English
- Each participant must have the ability to provide informed consent
Who cannot join
- Adults who do not receive an opioid prescription from a study Emergency Department AND/OR
- who do not have an adolescent, aged 12-18, living at home, AND/OR
- who do not speak or understand English
- Adults and/or adolescents who do not have the ability to provide informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
East Madison Hospital
Madison, Wisconsin, 53718
Melanie Hankes, 608-890-9098, MHankes@uwhealth.org
Kayla Zubke, 608-421-7367
University Hospital
Madison, Wisconsin, 53792
Allie Hurst, 608-263-3258, ahurst@medicine.wisc.edu
Allie Hurst, MD
Swedish American Hospital
Rockford, Illinois, 61104
Deanna Berg, 779-696-6152, DBerg3@uwhealth.org
Jessica Scott, 779-696-4243, JScott@uwhealth.org
About this study
Official title: Implementing MedSMA℞T Families in the Emergency Department Setting: A Game-based Approach for Improving Opioid Safety Among Adolescents and Parents
The goal of this clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. The main question it aims to answer is:
- Can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional opioid-related counseling alone?
Participants will, in addition to receiving opioid counseling:
- Join an online meeting with research staff to test the smartphone-based intervention
- Report demographic information
- Complete surveys about opioids
- Complete a family medication safety plan
- Complete surveys after 3, 6, and 9 months
- Conditions
- Opiate-Related Disorders, Opiate Use Disorder, Opioid
- Being tested
- MedSMA℞T Mobile
- Keywords
- Opioid Education, Opioid Use Disorder, Opiate-Related Disorders, Opiate, Opioid, Serious Game, Smartphone, Smartphone Game, Medication safety, Adolescent Health
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedSMA℞T MobileBehavioural
MedSMA℞T Mobile is an innovative mobile digital health intervention that integrates technology-based learning to facilitate family communication and creation of a personalized Family Medication Safety Plan. The Family Medication Safety Plan (FMSP) is a tool for families to record important information about their medications and create a plan for safe use, storage, and disposal. Participants will play MedSMA℞T Mobile for up to 30 minutes at the first study visit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This group will receive the intervention of interest, MedSMA℞T Mobile, in addition to standard opioid-related counseling. MedSMA℞T Mobile is a serious game (intended to educate while entertaining) focused on opioid safety. Receives: Behavioral: MedSMA℞T Mobile |
| Control | No intervention | This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study
The fourth factor of the Adolescent Opioid Safety and Learning (AOSL) scale, Opioid Harm, measures understanding of negative social and professional effects of opioid misuse. Scores range from 3-15, where 3 indicates the lowest level of overall opioid harm awareness and 15 is the highest level.
Measured: Baseline, 3, 6, and 9 months.
Secondary outcomes (4)
Change in Safe Opioid Storage Behaviour over 9 months
This outcome contains 4 items from the Wisconsin Strategic Prevention Framework Partnerships for Success Community Survey - V02, comprised of yes/no questions. The minimum score for this scale is 0 (indicating least safe opioid storage behaviour) and the maximum is 4 (indicating most safe opioid storage behaviour).
Measured: Baseline, 3, 6, and 9 months.
Change in Opioid Disposal Behaviour over 9 months
This outcome contains 6 items from the Wisconsin Strategic Prevention Framework Partnerships for Success Community Survey - V02, and includes yes/no questions. The minimum score for this scale is 0 (indicating least safe opioid disposal behaviour) and the maximum is 6 (indicating most safe opioid disposal behaviour).
Measured: Baseline, 3, 6, and 9 months.
Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months
This section covers the second factor, Learning About Medication, of the Medication Understanding and Use Self-Efficacy (MUSE) scale. This factor is comprised of 4 items, each scored 1-4. The minimum score is 4, and the maximum is 16. A score of 4 indicates lower understanding and self-efficacy in opioid use, whereas a score of 16 indicates highest level of understanding and self-efficacy in opioid use.
Measured: Baseline, 3, 6, and 9 months.
Change in Family Communication Behaviour Patterns over 9 months
This includes both the parent and child versions of the 26-item, 2-factor scales. The first factor, Conversation orientation, contains 15 items. The second factor, Conformity orientation, contains 11 items. Items are scored from 1-5, where 1 is "Disagree Strongly" and 5 is "Agree Strongly". Scale scores are averages for the two scales, with each item contributing equally. The minimum and maximum average scores, therefore, cannot exceed 1 and 5, respectively.
Measured: Baseline, 3, 6, and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study startAug 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate-Related DisordersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olufunmilola Abraham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olufunmilola Abraham, University of Kentucky
- Investigators
- Olufunmilola Abraham, PhD, Principal investigator, University of Kentucky College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848504
- Sponsor's protocol ID
- 98853
- Other IDs
- R18HS030202
- Status last verified
- Oct 2026
- First submitted
- 21 Feb 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing MedSMA℞T Families in the Emergency Department Setting: A Game-based Approach for Improving Opioid Safety Among Adolescents and Parents
- ClinicalTrials.gov ID
- NCT06848504
- Acronym / sponsor ID
- 98853
- Conditions
- Opiate-Related Disorders, Opiate Use Disorder, Opioid
- Keywords
- Opioid Education, Opioid Use Disorder, Opiate-Related Disorders, Opiate, Opioid, Serious Game, Smartphone, Smartphone Game
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Olufunmilola AbrahamUniversity, hospital or other
- Study start
- Aug 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Feb 2025 (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 clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. The main question it aims to answer is:
- Can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional opioid-related counseling alone?
Participants will, in addition to receiving opioid counseling:
- Join an online meeting with research staff to test the smartphone-based intervention
- Report demographic information
- Complete surveys about opioids
- Complete a family medication safety plan
- Complete surveys after 3, 6, and 9 months
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MedSMA℞T MobileThis group will receive the intervention of interest, MedSMA℞T Mobile, in addition to standard opioid-related counseling. MedSMA℞T Mobile is a serious game (intended to educate while entertaining) focused on opioid safety. |
| Control | No intervention | –This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adults who receive an opioid prescription from a study Emergency Department, AND
- who report having an adolescent, aged 12-18, living at home, AND
- who speak and understand English
- Each participant must have the ability to provide informed consent
Key exclusion criteria (4 listed)
- Adults who do not receive an opioid prescription from a study Emergency Department AND/OR
- who do not have an adolescent, aged 12-18, living at home, AND/OR
- who do not speak or understand English
- Adults and/or adolescents who do not have the ability to provide informed consent
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 |
|---|---|---|
| MedSMA℞T MobileMedSMA℞T Mobile is an innovative mobile digital health intervention that integrates technology-based learning to facilitate family communication and creation of a personalized Family Medication Safety Plan. The Family Medication Safety Plan (FMSP) is a tool for families to record important information about their medications and create a plan for safe use, storage, and disposal. Participants will play MedSMA℞T Mobile for up to 30 minutes at the first study visit. | Behavioural | Intervention |
Primary outcome
Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study
Time frame: Baseline, 3, 6, and 9 months.
The fourth factor of the Adolescent Opioid Safety and Learning (AOSL) scale, Opioid Harm, measures understanding of negative social and professional effects of opioid misuse. Scores range from 3-15, where 3 indicates the lowest level of overall opioid harm awareness and 15 is the highest level.
4 secondary outcomes
Change in Safe Opioid Storage Behaviour over 9 months
Time frame: Baseline, 3, 6, and 9 months.
Change in Opioid Disposal Behaviour over 9 months
Time frame: Baseline, 3, 6, and 9 months.
Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months
Time frame: Baseline, 3, 6, and 9 months.
Change in Family Communication Behaviour Patterns over 9 months
Time frame: Baseline, 3, 6, and 9 months.
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 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Olufunmilola Abraham, PhD principal investigator
University of Kentucky College of Pharmacy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedSMA℞T Mobile in people with Opiate-Related Disorders and Opiate Use Disorder, run by Olufunmilola Abraham at 3 sites 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 4 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Joseph Strong (859-562-2766, jmstrong@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study (time frame: Baseline, 3, 6, and 9 months.). 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 9 Oct 2026.