An interventional study of Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) and Control in Opioid Use Disorder, Pregnancy Related and Substance Use, sponsored by T. John Winhusen, PhD. Completed at 6 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by T. John Winhusen, PhD · Not applicable, Interventional, and Treatment
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Among 1,222 studies in Opioid-Related Disorders with a site in United States — 245 open to participants now, 315 under way, 18 of them phase 3. Opioid-Related Disorders · United States.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, this one is the 327th largest by enrollment of the 1,097 interventional ones that give a count, is one of 87 that started in 2024, is one of 570 with no phase, and was the 981st registered.
1,473 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →245 of the 1,222 studies in Opioid-Related Disorders with a site in United States are open now. Recruiting first, the newest first:
Washington State University · Sites in United States
Ages 18+
University of Massachusetts, Worcester · Sites in United States
Ages 18+ · Healthy volunteers
Baylor College of Medicine · Sites in United States
Ages 18–64
Yale University · Sites in United States
Ages 25–65 · Healthy volunteers
Adneuris Therapeutics, Inc. · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 53 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,222 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 162 · Phase 2 245 · Phase 3 99 · Phase 4 79
First in 1988; this study’s year is marked. 87 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 131 is above the median of 63 across 1,167 interventional studies indexed under Opioid-Related Disorders.
Median enrollment 56 across the 1,097 interventional studies, 85 across the 122 observational. Of the 834 that completed or were terminated, 331 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
132 of 1,222 have an industry lead sponsor. The 10 most frequent:
T. John Winhusen, PhD is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
T. John Winhusen, PhD has 6 studies filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
128 of the studies in Opioid-Related Disorders with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05011266Phase 3New York State Psychiatric InstituteEfficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder | 2027-01-01 |
| NCT05834478Phase 3Emory UniversityNon-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3 | 2027-02 |
| NCT05033028Phase 3NYU Langone HealthSmartphones for Opiate Addiction Recovery | 2027-06-01 |
| NCT05459402Phase 3University of Maryland, BaltimoreDivided or Single Exposure (DOSE) Study | 2027-06-01 |
| NCT05766631Phase 3Friends Research Institute, Inc.Treating Polysubstance Use Using a Novel Digital Technology | 2027-06-30 |
Add all 128 to your calendar (.ics) → With an account.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, from their registry updates:
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The primary objective of this study is to evaluate the ability of TOME to increase Medication for Opioid Use Disorder (MOUD) and opioid-overdose knowledge in pregnant and postpartum persons.
This is an intent-to-treat, two-arm, open-label, randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to TOME or Control, balancing on site. Participants will receive the assigned intervention following randomization and will complete a three week follow-up assessment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Potential participants must be:
Exclusion Criteria:
Potential participants must not:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Naloxone kit Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose. Behavioral: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME) TOME entails a trained RA: 1) administering a REDCap survey to assess an individual's opioid-overdose/MOUD knowledge; and 2) reviewing the personal feedback reports with the recipient.
Behavioral: Personally-Tailored Opioid-overdose and Medication for opioid use disorder (MOUD) Education (TOME)
Drug: Naloxone kit Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to participants, which may be useful in the event of a future opioid overdose. Behavioral: SAMHSA handouts SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; 2) "Opioid Overdose Prevention Toolkit: Recovering from Opioid Overdose"; and 3) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.
Behavioral: Control
The TOME intervention is a modified version of the personally-tailored opioid overdose prevention education and naloxone distribution (PTOEND) intervention (Winhusen et al. Evaluation of a personally-tailored opioid overdose prevention education and naloxone distribution intervention to promote harm reduction and treatment readiness in individuals actively using illicit opioids. Drug Alcohol Depend. Nov 1 2020;216:108265). Modifications include updating the knowledge assessment/education to reflect changes in the drug supply (i.e., the current high prevalence of fentanyl and increasing prevalence of xylazine) and the addition of items specific to pregnancy. Like PTOEND, TOME is a computer-guided intervention which utilizes REDCap to complete assessments and automatically generate personally-tailored feedback reports.
Participants randomized to the control condition will be offered three SAMHSA handouts.
Medication for Opioid Use Disorder (MOUD) Knowledge Score
This outcome is measured by the Opioid Overdose and Treatment Awareness Survey (OOTAS) knowledge evaluation: MOUD knowledge, potential score of 0-10; higher score indicates more knowledge. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.
Time frame: Week 3
Opioid Overdose Knowledge Score
This outcome is measured by the first three sections of the Opioid Overdose and Treatment Awareness Survey (OOTAS). Opioid-overdose knowledge, potential score of 0-31; higher score indicates more knowledge. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.
Time frame: Week 3
Medication for Opioid Use Disorder (MOUD) Internalized Stigma
This will be assessed with the The Methadone Maintenance Treatment Stigma Mechanisms Scale (MMT-SMS) questionnaire. Score range: 1 - 5; higher score indicates greater MOUD stigma
Time frame: Week 3
Drug Self-efficacy
This will be assessed with the Thoughts about abstinence (TAA) instrument. Drug Self-efficacy Score range: 0 - 9; higher score indicates greater expected success in avoiding drug use
Time frame: Week 3
| Milestone | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control |
|---|---|---|
| Started | 67 | 64 |
| Completed | 63 | 60 |
| Not completed | 4 | 4 |
| Withdrew: Lost to follow-up | 4 | 3 |
| Withdrew: Withdrawal by subject | 0 | 1 |
This outcome is measured by the Opioid Overdose and Treatment Awareness Survey (OOTAS) knowledge evaluation: MOUD knowledge, potential score of 0-10; higher score indicates more knowledge. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.
| percentage of correct answers | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control |
|---|---|---|
| Medication for Opioid Use Disorder (MOUD) Knowledge Score | 83.5 ± 15.6 | 72.0 ± 14.2 |
This outcome is measured by the first three sections of the Opioid Overdose and Treatment Awareness Survey (OOTAS). Opioid-overdose knowledge, potential score of 0-31; higher score indicates more knowledge. Values are converted to a percentage of correct answers from 0-100% where higher percentages mean more knowledge.
| percentage of correct answers | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control |
|---|---|---|
| Opioid Overdose Knowledge Score | 90.1 ± 7.6 | 82.6 ± 6.2 |
This will be assessed with the The Methadone Maintenance Treatment Stigma Mechanisms Scale (MMT-SMS) questionnaire. Score range: 1 - 5; higher score indicates greater MOUD stigma
| average score | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control |
|---|---|---|
| Medication for Opioid Use Disorder (MOUD) Internalized Stigma | 1.5 ± 0.7 | 1.6 ± 0.8 |
This will be assessed with the Thoughts about abstinence (TAA) instrument. Drug Self-efficacy Score range: 0 - 9; higher score indicates greater expected success in avoiding drug use
| average score | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control |
|---|---|---|
| Drug Self-efficacy | 2.3 ± 2.9 | 1.9 ± 2.6 |
Collected over Consent through Week 3. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
| Control | 0/64 (0%) | 0/64 (0%) | 0/64 (0%) |
| Age, Categorical(Participants) | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 67 | 64 | 131 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control | Total |
|---|---|---|---|
| Mean | 31.6 ± 5.0 | 30.7 ± 4.8 | 31.2 ± 4.9 |
| Sex: Female, Male(Participants) | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control | Total |
|---|---|---|---|
| Female | 67 | 64 | 131 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 7 | 10 |
| Not Hispanic or Latino | 64 | 57 | 121 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 58 | 59 | 117 |
| More than one race | 5 | 3 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Medication for Opioid Use Disorder (MOUD) Knowledge Score(percentage of correct answers) | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control | Total |
|---|---|---|---|
| Mean | 64.0 ± 15.4 | 69.5 ± 12.1 | 66.7 ± 14.1 |
| Opioid Overdose Knowledge Score(percentage of correct answers) | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control | Total |
|---|---|---|---|
| Mean | 81.7 ± 7.1 | 82.5 ± 5.6 | 82.1 ± 6.4 |
| Medication for Opioid Use Disorder (MOUD) Internalized Stigma(average score) | Personally-Tailored Opioid-overdose and Medication for Opioid Use Disorder (MOUD) Education (TOME) | Control | Total |
|---|---|---|---|
| Mean | 1.8 ± 0.7 | 1.7 ± 0.8 | 1.7 ± 0.8 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Primary data for this study will be available to the public in the NIDA data repository, per NIDA CTN policy.
Supporting information: Study protocol
Data sharing details ↗ · datashare.nida.nih.gov
Ran from Jun 2024 to primary completion in Nov 2024, 4 months.
Results were first posted in May 2025, 6 months after primary completion.
Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's 4 months is below that.
Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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T. John Winhusen, PhD