Opioid Use DisorderTRTMENCT07780097
TRTME: Improving Outpatient Initiation of Medication for Opioid Use Disorder Following Hospitalization
A study testing TRTME in people with Opioid Use Disorder and Opioid Use Disorder, Moderate, run by T. John Winhusen, PhD at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the ability of TRTME to increase initiation of MOUD outpatient treatment and MOUD knowledge in hospitalized patients with OUD deemed to be good candidates for MOUD by the UCMC Addiction Consult Team (ACT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
- What is being tested?
- TRTME
- 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
- 19 Aug 2026to 28 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- A good candidate for methadone or buprenorphine treatment according to a member of the UCMC Addiction Consult Team
Who cannot join
- Have a current planned discharge to a nursing facility
- be currently in jail, prison, or any inpatient overnight facility as required by court of law or have pending legal action with high probability of incarceration or court-mandated inpatient treatment
- Unable to demonstrate adequate understanding of study procedures during the consent process
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Cincinnati Addiction Sciences Division
Cincinnati, Ohio, 45229
About this study
Official title: A Pilot Randomized Controlled Trial to Improve Outpatient Initiation of Medication for Opioid Use Disorder (MOUD) Following Hospitalization: The TRTME (Tailored Overdose Risk Feedback, Testimonials for MOUD Treatment, and Education on MOUD and Opioid Overdose) Trial
The primary objective of this study is to evaluate the ability of TRTME to increase initiation of MOUD outpatient treatment and MOUD knowledge in hospitalized patients with OUD deemed to be good candidates for MOUD by the UCMC Addiction Consult Team (ACT). The secondary objective is to evaluate the ability of TRTME to decrease stigma and increase drug self-efficacy.
Read the detailed description
This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to TRTME or Control. Participants will receive the assigned intervention following randomization, will complete a post-assessment following treatment receipt, and will complete a follow-up phone call at approximately one month posthospital discharge.
All participants will complete assessments of their opioid-overdose and MOUD knowledge and their risk for experiencing an opioid-overdose during baseline. TRTME participants will be offered a 15-minute intervention in which a trained research staff member reviews personal feedback reports with the recipient to provide information on: 1) the items missed on the knowledge assessment; and 2) their personal overdose risk factors. TRTME participants will also have the opportunity to view short videos from patients talking about their experiences with methadone or buprenorphine treatment. Control participants will be offered two SAMHSA handouts.
Enrollment is expected to take place over a period of approximately 7.5 months. Duration of study participation will be approximately 5 weeks.
- Being tested
- TRTME
- Keywords
- opioid, Opioid Use Disorder, MOUD, buprenorphine, methadone
- Medical subject headings
- Opioid-Related Disorders, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRTMEBehavioural
The TRTME intervention includes three elements that have all been previously studied by our research team: 1) brief, personally-tailored education to correct inaccurate, common misconceptions about MOUD and to address knowledge gaps about opioid-overdose; 2) with personally-tailored feedback on the individual's risk factors for experiencing an opioid-overdose; and 3) review of MOUD testimonial videos.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control participants will be offered two SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; and 2) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically. |
| TRTME | Experimental | TRTME participants will be offered a 15-minute intervention in which a trained research staff member reviews personal feedback reports with the recipient to provide information on: 1) the items missed on the knowledge assessment; and 2) their personal overdose risk factors. TRTME participants will also have the opportunity to view short videos from patients talking about their experiences with methadone or buprenorphine treatment. Receives: Behavioral: TRTME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outpatient MOUD initiation
The primary outcome is verified enrollment in outpatient MOUD within 30 days post-discharge.
Participants will be asked about their enrollment in MOUD approximately 30 days after their discharge from the hospital. Participants reporting having enrolled in treatment will be asked to provide a release of information for the treatment program to verify date of treatment enrollment.
Measured: 30 days
Secondary outcomes (4)
MOUD knowledge score
The key secondary outcome is MOUD knowledge as measured by the Opioid Overdose and Treatment Awareness Survey (OOTAS) knowledge evaluation. The OOTAS is comprised of 4 sections: 1) opioid-overdose risk factors; 2) signs of an opioid-overdose; 3) how to respond to an opioid-overdose; and 4) misconceptions about MOUD. The OOTAS has been successfully used to measure MOUD knowledge and knowledge change in three studies. The OOTAS includes 10 true-false questions to assess MOUD knowledge, yielding a potential score of 0-10.Secondary Outcome Measures
Measured: Immediately after the intervention
MOUD Stigma
There are no existing validated measures for assessing MOUD stigma in patients who are good candidates for MOUD but have not yet entered treatment. The Medication for Opioid Use Disorder Attitudes Scale (MOUD-AS) was created by OpenEvidence based on stigmatizing beliefs about MOUD among patients considering treatment. The MOUD-AS includes 16 items scored from
1 (strongly disagree) to 5 (strongly agree). The total score, which has a potential range of 16-80, is the outcome of interest.
Measured: Immediately after the intervention
Drug Self-efficacy
Self-efficacy in quitting drug use will be assessed with the Thoughts about abstinence (TAA) instrument. This measure assesses the participant's desire to quit, expected success in quitting and estimated difficulty in avoiding drug use. Our MOUD education intervention has been found to increase expected success in quitting drug use as measured by the TAA.
Measured: Immediately after the intervention
Opioid-overdose knowledge score
Opioid-overdose knowledge will be measured by the first three sections of the OOTAS. The OOTAS has been successfully used to measure opioid-overdose knowledge and knowledge change in three prior studies conducted with individuals with OUD. The OOTAS includes 31 true-false questions to assess opioid-overdose knowledge, yielding a potential score of 0-31.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start19 Aug 2026
- Primary completion28 Feb 2027 (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 Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- T. John Winhusen, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, T. John Winhusen, PhD, University of Cincinnati
- Investigators
- T. John Winhusen, PhD., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780097
- Sponsor's protocol ID
- 2026-0331
- Acronym
- TRTME
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 28 Sep 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial to Improve Outpatient Initiation of Medication for Opioid Use Disorder (MOUD) Following Hospitalization: The TRTME (Tailored Overdose Risk Feedback, Testimonials for MOUD Treatment, and Education on MOUD and Opioid Overdose) Trial
- ClinicalTrials.gov ID
- NCT07780097
- Acronym / sponsor ID
- TRTME / 2026-0331
- Keywords
- opioid, Opioid Use Disorder, MOUD, buprenorphine, methadone
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- T. John Winhusen, PhDUniversity, hospital or other
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 21 Aug 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 primary objective of this study is to evaluate the ability of TRTME to increase initiation of MOUD outpatient treatment and MOUD knowledge in hospitalized patients with OUD deemed to be good candidates for MOUD by the UCMC Addiction Consult Team (ACT). The secondary objective is to evaluate the ability of TRTME to decrease stigma and increase drug self-efficacy.
Detailed description
This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to TRTME or Control. Participants will receive the assigned intervention following randomization, will complete a post-assessment following treatment receipt, and will complete a follow-up phone call at approximately one month posthospital discharge.
All participants will complete assessments of their opioid-overdose and MOUD knowledge and their risk for experiencing an opioid-overdose during baseline. TRTME participants will be offered a 15-minute intervention in which a trained research staff member reviews personal feedback reports with the recipient to provide information on: 1) the items missed on the knowledge assessment; and 2) their personal overdose risk factors. TRTME participants will also have the opportunity to view short videos from patients talking about their experiences with methadone or buprenorphine treatment. Control participants will be offered two SAMHSA handouts.
Enrollment is expected to take place over a period of approximately 7.5 months. Duration of study participation will be approximately 5 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control participants will be offered two SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; and 2) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically. |
| TRTME | Experimental | Behavioral: TRTMETRTME participants will be offered a 15-minute intervention in which a trained research staff member reviews personal feedback reports with the recipient to provide information on: 1) the items missed on the knowledge assessment; and 2) their personal overdose risk factors. TRTME participants will also have the opportunity to view short videos from patients talking about their experiences with methadone or buprenorphine treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older;
- A good candidate for methadone or buprenorphine treatment according to a member of the UCMC Addiction Consult Team
Key exclusion criteria (3 listed)
- Have a current planned discharge to a nursing facility
- be currently in jail, prison, or any inpatient overnight facility as required by court of law or have pending legal action with high probability of incarceration or court-mandated inpatient treatment
- Unable to demonstrate adequate understanding of study procedures during the consent process
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 |
|---|---|---|
| TRTMEThe TRTME intervention includes three elements that have all been previously studied by our research team: 1) brief, personally-tailored education to correct inaccurate, common misconceptions about MOUD and to address knowledge gaps about opioid-overdose; 2) with personally-tailored feedback on the individual's risk factors for experiencing an opioid-overdose; and 3) review of MOUD testimonial videos. | Behavioural | TRTME |
Primary outcome
Outpatient MOUD initiation
Time frame: 30 days
The primary outcome is verified enrollment in outpatient MOUD within 30 days post-discharge. Participants will be asked about their enrollment in MOUD approximately 30 days after their discharge from the hospital. Participants reporting having enrolled in treatment will be asked to provide a release of information for the treatment program to verify date of treatment enrollment.
4 secondary outcomes
MOUD knowledge score
Time frame: Immediately after the intervention
MOUD Stigma
Time frame: Immediately after the intervention
Drug Self-efficacy
Time frame: Immediately after the intervention
Opioid-overdose knowledge score
Time frame: Immediately after the 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 28 Sep 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.
T. John Winhusen, PhD. principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRTME in people with Opioid Use Disorder and Opioid Use Disorder, Moderate, run by T. John Winhusen, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 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: enrolling by invitation, as of the sponsor's last update on 28 Sep 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?
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?
Outpatient MOUD initiation (time frame: 30 days). 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 28 Sep 2026.