An interventional study of Transcranial Magnetic Stimulation (TMS) and Sham Transcranial Magnetic Stimulation (TMS) in Opioid Use Disorder and Major Depressive Disorder (MDD), sponsored by University of Kentucky. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Kentucky · Not applicable, Interventional, and Treatment
This study will compare transcranial magnetic stimulation (TMS) with sham TMS in people with opioid use disorder who are taking buprenorphine and have major depressive disorder with ongoing depressive symptoms. The study will evaluate whether TMS improves depressive symptoms and reduces opioid craving. The study will also assess smoking behaviors, treatment acceptability, and any side effects related to TMS.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 60 is close to the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →University of Kentucky is the lead sponsor of 68 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive active transcranial magnetic stimulation (TMS) using intermittent theta burst stimulation (iTBS).
Device: Transcranial Magnetic Stimulation (TMS)
Participants will receive sham transcranial magnetic stimulation (TMS) using the same treatment procedure without a significant electric field induced around the brain.
Device: Sham Transcranial Magnetic Stimulation (TMS)
Intermittent theta burst stimulation (iTBS) delivered over the left dorsolateral prefrontal cortex using a TMS coil.
Sham Transcranial Magnetic Stimulation (TMS) delivered using the same procedure as active TMS without a significant electric field induced around the brain.
Change in Depressive Symptom Severity
Change in depressive symptom severity as measured by the 17-item Hamilton Depression Rating Scale (HDRS-17) from baseline, comparing participants receiving transcranial magnetic stimulation (TMS) with those receiving Shame TMS. Higher scores indicate greater depressive symptom severity. The HDRS-17 ranges from 0-52.
Time frame: Baseline through Week 13
Change in Opioid Craving
Change in opioid craving as measured by the Opioid Craving Scale (OCS) from baseline, comparing participants receiving the TMS with those receiving sham TMS. The OCD consists of three items rated 0 to 10, with the total score calculated as the average of the three items. A higher score indicates greater opioid craving.
Time frame: Baseline through Week 13
Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.
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 planned 26 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get 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.
University of Kentucky