An interventional study of Deep TMS (DTMS) and Sham (No Treatment) in Alcohol Use Disorder, Alcoholism and Alcohol Abuse, sponsored by Brainsway. Recruiting at 11 sites in 3 countries. Open to participants aged 18 Years to 86 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Brainsway · Not applicable, Interventional, and Treatment
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Among 1,073 studies in Alcoholism with a site in United States — 187 open to participants now, 228 under way, 15 of them phase 3. Alcoholism · United States.
Among the 1,073 studies in Alcoholism with a site in United States, this one is the 214th largest by planned enrollment of the 989 interventional ones that give a count, is one of 56 that started in 2025, is one of 436 with no phase, reaches primary completion later than 137 of the 227 other live ones, and was the 1,025th registered.
1,676 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
Browse Alcoholism studies →187 of the 1,073 studies in Alcoholism 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 Pennsylvania · Sites in United States
Ages 21–65
National Institute on Drug Abuse (NIDA) · Sites in United States
Ages 18–120
National Institute on Drug Abuse (NIDA) · Sites in United States
Ages 21–100 · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 18+
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 237 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 131 (55%) stop at 75 or younger; 9 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 86 Years · 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.
1,073 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 1 138 · Phase 2 312 · Phase 3 77 · Phase 4 96
First in 1992; this study’s year is marked. 56 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 186 is above the median of 88 across 1,430 interventional studies indexed under Alcoholism.
Median enrollment 80 across the 989 interventional studies, 109 across the 79 observational. Of the 778 that completed or were terminated, 369 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
64 of 1,073 have an industry lead sponsor. The 10 most frequent:
Brainsway is the lead sponsor of 21 studies on the registry; 1 is open to participants now.
Brainsway has 1 study filed under Alcoholism — fewer than ten, so there is no comparison to draw.
83 of the studies in Alcoholism with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06173973Phase 3University of PennsylvaniaEffects of Ketone Supplementation on Acute Alcohol Withdrawal | 2026-12 |
| NCT05015881Phase 3University of PennsylvaniaRelationship Between Brain and Heart Glucose Metabolism in Alcohol Use Disorder | 2026-12 |
| NCT04616781Phase 3University of PennsylvaniaKetone Ester Intervention in Alcohol Use Disorder | 2026-12 |
| NCT06702007Phase 3University of WashingtonElectronic Harm Reduction Treatment for Alcohol | 2027-01 |
| NCT05613608Phase 3University of Colorado, DenverAlcohol Use Disorder and Cannabidiol | 2027-04 |
Add all 83 to your calendar (.ics) → With an account.
Among the 1,073 studies in Alcoholism 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 study will compare alcohol use in two groups of subjects. One group will be assigned to the Deep TMS treatment and the other group will be assigned to the sham treatment. This is a prospective, 6-month, double blind, randomized, controlled, multi-center trial in outpatients recruited in both academic and private research centers. The study population will consist of subjects diagnosed with moderate to severe AUD. The study is comprised of three phases:
Subjects of all ethnic and gender categories, ages ranging between 18-86 years will be screened for study eligibility according to the inclusion and exclusion criteria. Subjects who meet the eligibility criteria and are willing to sign an informed consent form will be enrolled in the study. The subjects' demographic and baseline characteristics, as well as their overall medical condition will be assessed prior to treatment administration.
Eligible patients will be randomized with a 1:1 ratio to one of two study groups (treatment or sham) and stratified by site. Randomization will be employed to avoid bias in the assignment of subjects to treatment group. All subjects will undergo the same treatment regimen, regardless of the assigned treatment group. The acute treatment phase will include 15 treatment visits over a period of 3-5 weeks.
The Maintenance Treatment \& Follow-up phase will include one treatment visit per week from the end of the Acute Treatment Phase until the 6 month follow-up visit.
At each treatment session, prior to stimulation onset, alcohol related cues will be presented to the subject. After the offset of the alcohol cue presentation, active or sham Deep TMS stimulation will be administered.
The study design is directed towards a comparison between active treatment and sham, up to 4 months and 6 months follow-up. Efficacy will be assessed using the primary efficacy measure of the percent heavy drinking days during months 2, 3 and 4, based on the Time Line Follow Back (TLFB) reporting and supportive PEth results. Additionally, several subject assessment scales will be used during the course of the study to assess alcohol use and alcohol craving.
Safety will be assessed, including monitoring the severity, causality and frequency of all adverse events, vital signs, and physical and neurological examination.
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:
Subjects with a significant neurological disorder or insult including, but not limited to:
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.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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 “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
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.
The treatment group will receive active, Deep TMS treatment.
Device: Deep TMS (DTMS)
The Control group will receive inactive, sham treatment.
Device: Sham (No Treatment)
The Deep TMS group will receive 30 active sessions in 15 visits (i.e., 2 treatments per visit) over a period of 3-5 weeks in the Acute Treatment Phase. In the Maintenance Treatment \& Follow-up phase subjects will receive one treatment session per week from the end of the Acute Treatment Phase until the 6-month follow-up visit. All treatment sessions will consist of 2 treatments per day with a 30 minute interval in between. Each treatment will last approximately 20 minutes.
The control group will receive 30 Sham sessions in 15 visits (i.e., 2 treatments per visit) over a period of 3-5 weeks in the Acute Treatment Phase. In the Maintenance Treatment \& Follow-up phase subjects will receive one treatment session per week from the end of the Acute Treatment Phase until the 6-month follow-up visit. All treatment sessions will consist of 2 treatments per day with a 30 minute interval in between. The control group will receive inactive/sham treatment with identical parameters to the Deep TMS treatment.
Difference in proportion of patients who attain zero (0) heavy drinking days
The difference in the proportion of patients who attain zero (0) heavy drinking days in the Treatment group versus the Sham control group in months 2, 3 and 4 following initiation of the Acute Phase, based on TLFB reporting and supportive PEth results. Month 1 is considered a "Grace Period" as this is the time during which the full treatment dose of the Acute Phase is being delivered.
Time frame: 2-4 months
Not enrolling at this site.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2027, 23 months after the start.
Of 493 interventional studies with no phase under Alcoholism, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 23 months is below that.
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 ↗
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