Opioid UsePhase 2NCT07673380
Leveraging mHealth to Promote Opioid Use Recovery and Mental Health Among Residents of a Medium-Sized Midwestern City
A Phase 2 study testing uMAT-R + enhanced community engagement and Original uMAT-R supplementary mHealth recovery intervention in people with Opioid Use and Stimulant Use, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The sequential trial compares recovery and mHealth engagement outcomes among Black participants who participated in the mHealth intervention uMAT-R or uMAT-R + enhanced community engagement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Stimulant Use, Depression and Anxiety Symptoms
- What is being tested?
- uMAT-R + enhanced community engagement and Original uMAT-R supplementary mHealth recovery intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2025to 28 Feb 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a history of opioid and/or stimulant use
- Identify as Black and/or African American
- Seek treatment at local substance use treatment centers
- Fluent in English
- U.S. resident
- 18 years of age or older at the time of data collection.
Who cannot join
- Self-reported cognitive impairment that would limit ability to participate in research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elecia Worley contact
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Hannah Szlyk, PhD, 917-836-4225, szlyk@wustl.edu
About this study
Official title: Leveraging mHealth to Promote Recovery From Opioid Use Disorder and Commonly Occurring Mental Health Disorders Among Residents of a Medium-Sized Midwestern City
The sequential trial compares recovery and mHealth engagement outcomes among Black participants who participated in the mHealth intervention uMAT-R or uMAT-R + enhanced community engagement. The mHealth intervention seeks to support people in various stages of recovery who are also seeking other forms of substance use treatment. Participants are recruited from community-based substance use treatment facilities and recovery services. Participants must be adults who have or are currently using opioids and/or stimulants.
- Conditions
- Opioid Use, Stimulant Use, Depression and Anxiety Symptoms
- Being tested
- uMAT-R + enhanced community engagement, Original uMAT-R supplementary mHealth recovery intervention
- Keywords
- Digital health, Community engagement
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uMAT-R + enhanced community engagementBehavioural
uMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team. This involves in-person interactions with eligible participants and recruitment sites.
Original uMAT-R supplementary mHealth recovery interventionBehavioural
uMAT-R supplementary mHealth recovery intervention is the original intervention without optimization of the community engagement approach.
| Study group | Role | What they receive |
|---|---|---|
| uMAT-R + enhanced community engagement | Experimental | uMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team. Receives: Behavioral: uMAT-R + enhanced community engagement |
| Original uMAT-R supplementary mHealth recovery intervention | Active comparator | uMAT-R supplementary mHealth recovery intervention is the original intervention disseminated without optimization of the community engagement approach. Receives: Behavioral: Original uMAT-R supplementary mHealth recovery intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence/ Changes in Substance Use
Frequency of opioid use, stimulant, and/or other substance use (e.g., discordant with prescribed usage) or other substances (e.g., stimulants, other non-opioid illicit drugs) in the past 30-day will be assessed by items from the National Survey on Drug Use and Health (NSDUH) questionnaire. The score indicates days on using any substance listed above over past 30-day, ranging from 0 to 30, with a higher score reflecting more frequent substance use.
Measured: Time 0 (Baseline) and Time 1 (One Month)
Opioid use/ Stimulant use disorder symptoms
The number of DSM-5-TR diagnostic criteria met for opioid use disorder (OUD) and stimulant use disorder (StUD) will be assessed. Scores range from 0 to 11, with higher scores indicating that more diagnostic criteria are met for the disorder.
Measured: Time 0 (Baseline) and Time 1 (One Month)
Secondary outcomes (5)
Depression symptoms
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depression symptoms. The potential scale scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Continuous variables will be created to assess the total scores at baseline and the 1-month follow-up, respectively.
Measured: Time 0 (Baseline) and Time 1 (One-Month)
Anxiety Symptoms
The Generalized Anxiety Disorder Assessment-7 (GAD-7) will be used to assess anxiety symptoms. Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), allowing for a comprehensive evaluation of anxiety symptoms in the past 2 weeks, such as 'Feeling nervous, anxious, or on edge' or 'Becoming easily annoyed or irritable...' The potential scale scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. To examine the changes in GAD-7 scores from baseline to the 1-month follow-up, continuous variables will be created to assess the scores at the respective time points.
Measured: Time 0 (Baseline) and Time 1 (One-Month)
Basic needs
The adapted Wellbeing and Basic Needs Survey will be used to assess confidence in meeting their basic needs. Participants were asked to rate their confidence in meeting their basic needs on a Likert scale ranging from "very confident" (1) to "not confident at all" (8). To examine changes in scores continuous variables were created to capture the baseline and 1-month follow-up scores, respectively. Scores may range from 8 to 64, which higher scores indicating less confidence in attending to basic needs.
Measured: Time 0 (Baseline) and Time 1 (One-Month)
Medication for Opioid Use Disorder (MOUD) Attitudes
We will measure Medication for Opioid Use Disorder (MOUD) attitudes using an 8-item subscale to evaluate participants' attitudes towards MOUD modified from the Attitudes of Methadone Scale. Participants will provide responses on a 5-point Likert scale, ranging from 'strongly disagree' (1) to 'strongly agree' (5). Sample items include: 'Taking MOUD is only replacing one addiction with another,' 'A person is better off taking MOUD than opioids,' and 'MOUD is as dangerous as opioids.' The total score will be calculated by summing all items, resulting in a potential scoring range of 8 to 40 with higher scores indicating greater negative attitudes toward MOUD use.
Measured: Time 0 (Baseline), and Time 1 (One-Month)
Substance Use Disorder (SUD) Treatment Engagement
Participants will be asked if they are enrolled and receive specialty substance use care, and/or medication for Opioid Use Disorder, assessed by self-report. "Are you currently enrolled in a treatment plan or program for substance use care?" "Are you currently being prescribed medication for opioid use disorder (MOUD)"
Response options will include "yes" or "no." If a participant responds "yes" to at least one question, the final outcome for substance use treatment engagement will be coded as "yes." "No" responses to both questions will be coded as "No."
Measured: Time 0 (Baseline), and Time 1 (One-Month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start31 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673380
- Sponsor's protocol ID
- 202308065
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging mHealth to Promote Recovery From Opioid Use Disorder and Commonly Occurring Mental Health Disorders Among Residents of a Medium-Sized Midwestern City
- ClinicalTrials.gov ID
- NCT07673380
- Acronym / sponsor ID
- 202308065
- Conditions
- Opioid Use, Stimulant Use, Depression and Anxiety Symptoms
- Keywords
- Digital health, Community engagement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 31 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 29 Jun 2026 (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 sequential trial compares recovery and mHealth engagement outcomes among Black participants who participated in the mHealth intervention uMAT-R or uMAT-R + enhanced community engagement. The mHealth intervention seeks to support people in various stages of recovery who are also seeking other forms of substance use treatment. Participants are recruited from community-based substance use treatment facilities and recovery services. Participants must be adults who have or are currently using opioids and/or stimulants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| uMAT-R + enhanced community engagement | Experimental | Behavioral: uMAT-R + enhanced community engagementuMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team. |
| Original uMAT-R supplementary mHealth recovery intervention | Active comparator | Behavioral: Original uMAT-R supplementary mHealth recovery interventionuMAT-R supplementary mHealth recovery intervention is the original intervention disseminated without optimization of the community engagement approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a history of opioid and/or stimulant use
- Identify as Black and/or African American
- Seek treatment at local substance use treatment centers
- Fluent in English
- U.S. resident
Key exclusion criteria (1 listed)
- Self-reported cognitive impairment that would limit ability to participate in research.
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 |
|---|---|---|
| uMAT-R + enhanced community engagementuMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team. This involves in-person interactions with eligible participants and recruitment sites. | Behavioural | uMAT-R + enhanced community engagement |
| Original uMAT-R supplementary mHealth recovery interventionuMAT-R supplementary mHealth recovery intervention is the original intervention without optimization of the community engagement approach. | Behavioural | Original uMAT-R supplementary mHealth recovery intervention |
Primary outcome
Abstinence/ Changes in Substance Use
Time frame: Time 0 (Baseline) and Time 1 (One Month)
Frequency of opioid use, stimulant, and/or other substance use (e.g., discordant with prescribed usage) or other substances (e.g., stimulants, other non-opioid illicit drugs) in the past 30-day will be assessed by items from the National Survey on Drug Use and Health (NSDUH) questionnaire. The score indicates days on using any substance listed above over past 30-day, ranging from 0 to 30, with a higher score reflecting more frequent substance use.
Opioid use/ Stimulant use disorder symptoms
Time frame: Time 0 (Baseline) and Time 1 (One Month)
The number of DSM-5-TR diagnostic criteria met for opioid use disorder (OUD) and stimulant use disorder (StUD) will be assessed. Scores range from 0 to 11, with higher scores indicating that more diagnostic criteria are met for the disorder.
5 secondary outcomes
Depression symptoms
Time frame: Time 0 (Baseline) and Time 1 (One-Month)
Anxiety Symptoms
Time frame: Time 0 (Baseline) and Time 1 (One-Month)
Basic needs
Time frame: Time 0 (Baseline) and Time 1 (One-Month)
Medication for Opioid Use Disorder (MOUD) Attitudes
Time frame: Time 0 (Baseline), and Time 1 (One-Month)
Substance Use Disorder (SUD) Treatment Engagement
Time frame: Time 0 (Baseline), and Time 1 (One-Month)
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 29 Jun 2026.
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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.
Elecia Worley contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing uMAT-R + enhanced community engagement and Original uMAT-R supplementary mHealth recovery intervention in people with Opioid Use and Stimulant Use, run by Washington University School of Medicine 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 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: looking for participants now, as of the sponsor's last update on 29 Jun 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hannah Szlyk (917-836-4225, szlyk@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence/ Changes in Substance Use (time frame: Time 0 (Baseline) and Time 1 (One Month)). The study lists 2 primary outcomes in all. 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 29 Jun 2026.