Alcohol Use DisorderNCT07216872
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
A study testing Deep TMS (DTMS) in people with Alcohol Use Disorder and Alcoholism, run by Brainsway at 11 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Alcohol Use Disorder, Alcoholism, Alcohol Abuse
- What is being tested?
- Deep TMS (DTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 11 sitesin 3 countries
- Study dates
- 7 Nov 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18-86 years old.
- Subjects diagnosed with AUD and who meet criteria for moderate (4-5 out of the 12 symptoms) to severe (> 6 out of the 12 symptoms) AUD according to the DSM-5 diagnostic criteria as determined by a licensed clinician according to the DSM-5 criteria, and verified with the Mini International Neuropsychiatric Interview (Standard MINI version 7.0.2).
- Subjects who have a history of at least 24 heavy drinking days during the 90 days prior to screening, based on TLFB.
- Treatment seeking individuals with a treatment goal of achieving abstinence or reducing heavy drinking.
- Subjects able to understand and provide signed informed consent, and able to adhere to the requirements and restrictions of this protocol.
- Satisfactory answers on safety screening questionnaire for transcranial magnetic stimulation.
Who cannot join
- Subjects diagnosed with schizophrenia or chronic psychotic disorder as determined by a licensed clinician according to the DSM-5 criteria, and verified with the Mini International Neuropsychiatric Interview (Standard MINI version 7.0.2).
- Subjects with present suicidal risk as assessed by the investigator or significant suicide risk based on MADRS item 10 score of 4 or 6, or a history of attempted suicide in the last year.
- Subjects who initiated treatment with any of the following medications which are known to effect alcohol consumption, within 30 days of the Screening visit: acamprosate, baclofen, buprenorphine, disulfiram, gabapentin, naltrexone, topiramate and varenicline.
- Subjects with a significant medical illness that is not well controlled (e.g., hepatic impairment, diabetes, hypertension, heart disease, septicemia, active tuberculosis, progressive neoplasm, frequent and severe migraine headaches, etc.).
- Subjects experiencing acute alcohol withdrawal. This will be determined using the Clinical Institute Withdrawal Assessment of Alcohol - revised (CIWA-Ar) wherein subjects with a value of >7 will not be permitted to receive TMS on that day to mitigate any potential risk of a seizure. Treatments may be rescheduled and CIWA-AR and alcohol breath tests may be reassessed, although if more than the allowed treatment sessions are missed, the subject will be withdrawn from the study.
- Subjects with a history of epilepsy or seizure (not including history of alcohol withdrawal seizure, ECT induced seizures, or childhood febrile seizures).
Show all 28Show fewer
- Individuals with a first-degree relative family history of seizure.
- Subjects with a high risk for severe violence or suicidality as assessed during the screening interview.
- Conductive, ferromagnetic or other magnetic-sensitive metals implanted in the head (outside the mouth) or within 10 cm of the treatment coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, shrapnel, surgical clips, fragments from welding or metal work).
- Subjects with cardiac pacemakers or active implantable electrodes/neurostimulators within 30 cm of the treatment coil.
- Subjects with a significant neurological disorder or insult including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- Dementia
- Mini Mental State Exam score of less than or equal to 24
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Subjects suffering from significant hearing loss.
- Previous treatment with TMS within one year.
- Subject's motor threshold cannot be located or is > 58%.
- Participation in another clinical investigation in which a device or drug has been used within 4 weeks of screening.
- If participating in psychotherapy, subject is not in stable treatment for at least 3 months prior to entry into the study or anticipates a change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial.
- Known or suspected pregnancy or planning to become pregnant.
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
Trial locations and contacts
11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 3 countries
United States9 sites, 8 recruiting
- Not yet recruiting
Inner Healing Charleston
Charleston, South Carolina, 29403
Claire Floyd, 843-273-6532, claire@innerhealingchs.com
Suzanne Kerns, MD
- Recruiting
Rosecrance River North
Chicago, Illinois, 60654
Ana Isabella Ovalle, 815-720-5076, aovalle@rosecrance.org
Puneet Lakhmani, MD
- Recruiting
Optimum Wellness and TMS
Columbus, Ohio, 43215
Adam Barber, 614-933-4200, aj@optimumtms.com
Mark Blair, MD
- Recruiting
Kadima Neuropsychiatry
La Jolla, California, 92037
Sydney Pollard, 858-412-4130, sydneyp@kadimanp.com
David Feifel, MD
- Terminated
Active Path Mental Health
Portland, Oregon, 97223
- Recruiting
PsyCare
South Charleston, West Virginia, 25303
Nancy Williams, 304-768-6170, nwilliams@psycareinc.com
Russ Voltin, MD
- Recruiting
Alpha Neuron LLC
Tuscaloosa, Alabama, 35401
Mallory Bates, 205-523-5618, mallorybates@novusneuro.com
Timothy Prestley, MD
- Recruiting
DTMS Center LLC
West Palm Beach, Florida, 33411
Noelia Rodriguez, 561-749-9999, noelia@doctortendler.com
Aron Tendler, MD
- Recruiting
ManuMind Interventional Psychiatry
Woodbury, New York, 11797
Lisa Cottone, 516-808-0888, lisa.cottone@manumind.com
Lucian Manu
Israel1 site, 1 recruiting
- Recruiting
Soroka Medical Center
Beersheba, 8410501
Rachel Ozeri, rozeri99@gmail.com
Tali Gulevsky, gulevsky@post.bgu.ac.il
Sweden1 site, 1 recruiting
- Recruiting
Linköping University
Linköping
Asa Axen, 46-13-282947, asa.axen@liu.se
Markus Heilig, Prof.
About this study
Official title: A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With Alcohol Use Disorder (AUD)
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:
- Pre-study Screening and Baseline Phase
- Acute Treatment Phase and
- Maintenance Treatment and Follow up Phase
Read more
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.
- Conditions
- Alcohol Use Disorder, Alcoholism, Alcohol Abuse, Alcohol Dependence, Alcohol Abuse/Dependence, Alcohol Addiction
- Being tested
- Deep TMS (DTMS), Sham (No Treatment)
- Keywords
- alcohol use disorder, alcoholism, alcohol abuse, alcohol dependence, alcohol addiction, DTMS, rfTMS, Brainsway
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep TMS (DTMS)Device
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.
Sham (No Treatment)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The treatment group will receive active, Deep TMS treatment. Receives: Device: Deep TMS (DTMS) |
| Control group | Sham comparator | The Control group will receive inactive, sham treatment. Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start7 Nov 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized, double-blind, sham-controlled, multicenter trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216872
- Sponsor's protocol ID
- CTP-AUD-00
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With Alcohol Use Disorder (AUD)
- ClinicalTrials.gov ID
- NCT07216872
- Acronym / sponsor ID
- CTP-AUD-00
- Conditions
- Alcohol Use Disorder, Alcoholism, Alcohol Abuse, Alcohol Dependence, Alcohol Abuse/Dependence, Alcohol Addiction
- Keywords
- alcohol use disorder, alcoholism, alcohol abuse, alcohol dependence, alcohol addiction, DTMS, rfTMS, Brainsway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pre-study Screening and Baseline Phase
- Acute Treatment Phase and
- Maintenance Treatment and Follow up Phase
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The study is a randomized, double-blind, sham-controlled, multicenter trial.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Deep TMS (DTMS)The treatment group will receive active, Deep TMS treatment. |
| Control group | Sham comparator | Device: Sham (No Treatment)The Control group will receive inactive, sham treatment. |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects, 18-86 years old.
- Subjects diagnosed with AUD and who meet criteria for moderate (4-5 out of the 12 symptoms) to severe (> 6 out of the 12 symptoms) AUD according to the DSM-5 diagnostic criteria as determined by a licensed clinician according to the DSM-5 criteria, and verified with the Mini International Neuropsychiatric Interview (Standard MINI version 7.0.2).
- Subjects who have a history of at least 24 heavy drinking days during the 90 days prior to screening, based on TLFB.
- Treatment seeking individuals with a treatment goal of achieving abstinence or reducing heavy drinking.
- Subjects able to understand and provide signed informed consent, and able to adhere to the requirements and restrictions of this protocol.
Key exclusion criteria (28 listed)
- Subjects diagnosed with schizophrenia or chronic psychotic disorder as determined by a licensed clinician according to the DSM-5 criteria, and verified with the Mini International Neuropsychiatric Interview (Standard MINI version 7.0.2).
- Subjects with present suicidal risk as assessed by the investigator or significant suicide risk based on MADRS item 10 score of 4 or 6, or a history of attempted suicide in the last year.
- Subjects who initiated treatment with any of the following medications which are known to effect alcohol consumption, within 30 days of the Screening visit: acamprosate, baclofen, buprenorphine, disulfiram, gabapentin, naltrexone, topiramate and varenicline.
- Subjects with a significant medical illness that is not well controlled (e.g., hepatic impairment, diabetes, hypertension, heart disease, septicemia, active tuberculosis, progressive neoplasm, frequent and severe migraine headaches, etc.).
- Subjects experiencing acute alcohol withdrawal. This will be determined using the Clinical Institute Withdrawal Assessment of Alcohol - revised (CIWA-Ar) wherein subjects with a value of >7 will not be permitted to receive TMS on that day to mitigate any potential risk of a seizure. Treatments may be rescheduled and CIWA-AR and alcohol breath tests may be reassessed, although if more than the allowed treatment sessions are missed, the subject will be withdrawn from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep TMS (DTMS)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. | Device | Treatment group |
| Sham (No Treatment)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. | Device | Control group |
Primary outcome
Difference in proportion of patients who attain zero (0) heavy drinking days
Time frame: 2-4 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep TMS (DTMS) in people with Alcohol Use Disorder and Alcoholism, run by Brainsway at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Israel, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahava Stein (+972-9-7670002, ahava@asteinrac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in proportion of patients who attain zero (0) heavy drinking days (time frame: 2-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.