A Phase 2 interventional study of Tirzepatide and Placebo in Opioid Use Disorder, Opioid Use Disorder, Moderate and Opioid Use Disorder, Severe, sponsored by T. John Winhusen, PhD. Recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by T. John Winhusen, PhD · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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 155th largest by planned enrollment of the 1,097 interventional ones that give a count, is one of 83 that started in 2026, is one of 190 in phase 2, reaches primary completion later than 186 of the 314 other live ones, and was the 1,060th 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 · all sexes · 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. 83 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 310 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:
This tab as a report to print or save as PDF → With an account.
The primary objective of this research study is to evaluate the effect of tirzepatide, relative to placebo, as an adjunct to BUP on retention, substance use, and sleep outcomes in individuals with OUD.
This is a Phase 2, pragmatic, multi-site, double-blind, randomized, placebo-controlled, intent-to-treat trial. The selection of placebo as the comparator is considered the gold standard for medication trials. Eligible participants will be randomized in a 1:1 ratio to tirzepatide or placebo, balancing on site and buprenorphine (BUP) formulation (transmucosal vs extended-release).
Participants will receive tirzepatide or placebo based on randomized assignment, with "dose escalation" of placebo following the schedule for tirzepatide and tirzepatide dosing being consistent with prescribing guidelines. Participants will be administered a subcutaneous (SQ) study medication injection weekly and attend weekly research visits through 26 weeks post-randomization with longer research visits at 1, 3, and 6 months post-randomization. A follow-up visit for final safety measures will be completed at week 30, which takes into account tirzepatide's long half-life.
Duration of participation will be approximately 31 weeks for study participants. Participants will be administered study medication and attend weekly research visits through 6 months post-randomization with longer research visits at 1-, 3-, and 6-months post-randomization. Participants will be provided with a Fitbit to measure sleep. BUP is not a study medication; participants will receive BUP through their clinical provider. A follow-up visit for final safety measures will be completed at week 30.
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.
Must not be breastfeeding; if of child bearing potential, must test negative on the study-administered pregnancy test(s), and if of and engaging /planning to engage in sexual intercourse must agree to effective for the duration of the trial through 30 days after the trial; effective contraception is defined as using: a) birth control injection, an intrauterine device, or implant; or b) two birth control methods - for example birth control pills with a barrier method (e.g., condoms, etc.).
If ever of childbearing potential, a participant is considered to not be of childbearing potential for the study if they are:
Exclusion Criteria:
have a current, or within the 30 days prior to signing consent, use of, or plan to start during the course of the trial:
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The tirzepatide pen is a pre-filled, disposable, injection device designed for subcutaneous administration. Each pen is pre-filled with a single dose of tirzepatide and is available in six doses: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg/0.5 mL. An unblinded study MC (UMC) will administer the once-weekly SQ dose of tirzepatide. Consistent with tirzepatide's prescribing guidelines, participants will be initiated at a once-weekly SQ dose of 2.5 mg/week with a dose increase to 5mg/week at week 5. Consistent with tirzepatide's prescribing information, once the participant has received 5 mg/week for 4 weeks they are eligible for a dose increase if needed.
Drug: Tirzepatide
Saline administered subcutaneously with a syringe will be used as the placebo for the trial. The placebo which will be administered by a study UMC. The process for deciding on "dose increases" will be the same for placebo and tirzepatide.
Other: Placebo
The tirzepatide pen is a pre-filled, disposable, injection device designed for subcutaneous administration. Each pen is pre-filled with a single dose of tirzepatide and is available in six doses: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg/0.5 mL. A UMC will administer the once-weekly SQ dose of tirzepatide. Consistent with tirzepatide's prescribing guidelines, participants will be initiated at a once-weekly SQ dose of 2.5 mg/week with a dose increase to 5mg/week at week 5. Consistent with tirzepatide's prescribing information, once the participant has received 5 mg/week for 4 weeks they are eligible for a dose increase if needed
Also known as: Mounjaro, Zepbound
Saline administered subcutaneously with a syringe will be used as the placebo for the trial. The placebo which will be administered by a study UMC. The process for deciding on "dose increases" will be the same for placebo and tirzepatide.
6-month retention in BUP treatment
MOUD is defined as buprenorphine (BUP). The receipt of BUP will be assessed thorough self-report collected through a Timeline Follow-Back (TLFB) procedure and will be partially verified through urine drug screens.
Time frame: 6 months
Proportion of illicit opioid-negative urine samples during the 6-month active treatment phase
A rapid Urine Drug Screen (UDS)UDS system will be used to analyze the urine samples. Illicit opioid-negative UDSs are defined as being negative for fentanyl, opiates, oxycodone, and methadone (unless the participant starts methadone treatment).
Time frame: 6 Months
Proportion of UDS negative for non-opioid (and cotinine) drugs and alcohol
A rapid Urine Drug Screen (UDS)UDS system will be used to analyze the urine samples. Negative urine samples are defined as being negative for: cocaine, methamphetamine, amphetamine, marijuana, benzodiazepines, methylenedioxymethamphetamine, barbiturates, phencyclidine, and ethyl glucuronide.
Time frame: 6 months
Treatment Effectiveness
Treatment Effectiveness will be measured by the Treatment Effectiveness Assessment (TEA). The TEA is a patient-oriented instrument that assesses the participant's perceived improvements in substance use, health, ability to fulfill adult obligations, and to be a good community member. The TEA includes four items, each rated on a 1-10-point scale (from none to much better) yielding a total score of 4-40.
Time frame: 6 months
Sleep Quality - Fitbit Charge 6™ (FBC-6)
An objective measure of the impact of tirzepatide, relative to placebo, on sleep will be obtained using the Fitbit Charge 6™ (FBC-6). A comparison of an earlier version of the device (Fitbit Charge 4™) to polysomnography found no significant differences in the measures of total sleep time and waking after sleep onset. Each participant will be provided with a Fitbit Charge 6™ when they are deemed eligible for randomization and asked to wear it every night (or whenever they have their longer period of intended sleep) through the final study visit. Data from the Fitbit Charge 6™ will be downloaded at the weekly research visits. Total sleep time is the main outcome of interest.
Time frame: 6 months
Sleep Quality - The Pittsburgh Sleep Quality Index (PSQI)
Participant perceived sleep quality will be assessed using the PSQI, which is a relatively brief, validated instrument that measures sleep quality.
Time frame: 6 months
Plan to share: Yes — De-identified participant-level data gathered from case report forms.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: June 30, 2028 (anticipated)
Access criteria: Primary data for this study will be available to the public in the NIDA data repository, per NIDA CTN policy. For more details on data sharing please visit https://datashare.nida.nih.gov/.
Data sharing details ↗ · datashare.nida.nih.gov
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Sep 2027, 20 months after the start.
Of 61 non-industry phase 2 interventional studies under Opioid-Related Disorders, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 20 months is below that.
Counting every sponsor, half of 68 studies reached it within 40 months; a quarter within 23 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tirzepatide
T. John Winhusen, PhD