BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for adults with alcohol use disorder
A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment of Alcohol Use Disorder (AUD)
This study will test whether BrainsWay Deep TMS can reduce heavy drinking in adults with moderate to severe alcohol use disorder compared with a sham procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 18 Years to 86 Years |
| Sex | All |
| Sponsor | Brainsway Industry-sponsored |
| Locations | 9 sites (Tuscaloosa, Alabama and 8 other locations) |
| Trial ID | NCT07216872 on ClinicalTrials.gov |
What this trial studies
This is a prospective, double-blind, randomized, sham-controlled, multicenter outpatient trial lasting six months that compares active BrainsWay Deep TMS with a sham device in adults with moderate to severe AUD. The protocol includes a pre-study screening and baseline phase, an acute treatment phase, and a maintenance and follow-up phase. Eligible participants are treatment-seeking adults aged 18–86 with DSM-5 moderate to severe AUD and a recent history of heavy drinking. Alcohol use measures and safety outcomes will be tracked over the six-month period to determine whether Deep TMS changes drinking behavior.
Who should consider this trial
Good fit: Ideal candidates are treatment-seeking adults 18–86 years old with DSM-5 moderate to severe AUD who have had at least 24 heavy drinking days in the 90 days before screening and who are eligible for TMS.
Not a fit: People with excluded conditions such as schizophrenia or other chronic psychotic disorders, those who do not meet the heavy-drinking threshold, or those with contraindications to TMS may not receive benefit from this approach.
Why it matters
Potential benefit: If successful, Deep TMS could provide a non-drug outpatient option that helps reduce heavy drinking and support abstinence for some people with AUD.
How similar studies have performed: Some prior TMS studies for alcohol and other substance use disorders have shown promising but mixed results, so this trial builds on emerging but not yet definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Male or female subjects, 18-86 years old.
2. 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).
3. Subjects who have a history of at least 24 heavy drinking days during the 90 days prior to screening (average \>=8 HDD/month), based on TLFB).
4. Treatment seeking individuals with a treatment goal of achieving abstinence or reducing heavy drinking.
5. Subjects able to understand and provide signed informed consent, and able to adhere to the requirements and restrictions of this protocol.
6. Satisfactory answers on safety screening questionnaire for transcranial magnetic stimulation.
Exclusion Criteria:
1. 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).
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.
3. 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.
4. 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.).
5. 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.
6. Subjects with a history of epilepsy or seizure (not including history of alcohol withdrawal seizure, ECT induced seizures, or childhood febrile seizures).
7. Individuals with a first-degree relative family history of seizure.
8. Subjects with a high risk for severe violence or suicidality as assessed during the screening interview.
9. 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).
10. Subjects with cardiac pacemakers or active implantable electrodes/neurostimulators within 30 cm of the treatment coil.
11. 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
12. Subjects suffering from significant hearing loss.
13. Previous treatment with TMS within one year.
14. Participation in another clinical investigation in which a device or drug has been used within 4 weeks of screening.
15. 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.
16. Known or suspected pregnancy or lactation or planning to become pregnant.
17. Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
Where this trial is running
Tuscaloosa, Alabama and 8 other locations
- Alpha Neuron LLC — Tuscaloosa, Alabama, United States (Recruiting)
- Kadima Neuropsychiatry — La Jolla, California, United States (Recruiting)
- DTMS Center LLC — West Palm Beach, Florida, United States (Recruiting)
- Rosecrance River North — Chicago, Illinois, United States (Recruiting)
- ManuMind Interventional Psychiatry — Woodbury, New York, United States (Recruiting)
- Optimum Wellness and TMS — Columbus, Ohio, United States (Not_yet_recruiting)
- Active Path Mental Health — Portland, Oregon, United States (Not_yet_recruiting)
- PsyCare — South Charleston, West Virginia, United States (Recruiting)
- Soroka Medical Center — Beersheba, Israel (Not_yet_recruiting)
Study contacts
- Study coordinator: Ahava Stein
- Email: ahava@asteinrac.com
- Phone: +972-9-7670002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.