Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07780097

TRTME: Improving Outpatient Initiation of Medication for Opioid Use Disorder Following Hospitalization

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Narcotic-Related Disorders Neoplasms Neoplasms by Histologic Type Opioid Use Disorder, Moderate Opioid Use Disorder, Severe Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati Addiction Sciences Division

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older;
  • A good candidate for methadone or buprenorphine treatment according to a member of the UCMC Addiction Consult Team

Exclusion criteria

  • 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

Treatment and study plan

TRTME

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. MOUD knowledge score

    Time frame: Immediately after the intervention

    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

  2. MOUD Stigma

    Time frame: Immediately after the intervention

    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.

  3. Drug Self-efficacy

    Time frame: Immediately after the intervention

    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.

  4. Opioid-overdose knowledge score

    Time frame: Immediately after the intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ben Kropp Kropp, MSLS

CONTACT

[email protected]

5135858287

Lindsay Bybee, MS

CONTACT

[email protected]

5135858282

Sponsors and collaborators

Lead sponsor

T. John Winhusen, PhD

Other

Registry information

Official study 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

Acronym: TRTME

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.