Deep TMS for Alcoholism

Recruiting at 6 trial locations

Overseen By Ahava Stein

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brainsway

Must not be taking: Acamprosate, Baclofen, Naltrexone, others

Disqualifiers: Bipolar, Schizophrenia, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

186 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Deep Transcranial Magnetic Stimulation (Deep TMS), which uses magnetic fields, can assist individuals with moderate to severe alcohol use disorder (AUD). Participants will be divided into two groups: one receiving the actual treatment and the other a sham (inactive) version. The study will monitor changes in drinking habits over six months. It seeks individuals who have experienced at least 24 heavy drinking days in the past 90 days and wish to reduce or quit drinking. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially benefit from an innovative treatment.

Do I need to stop my current medications to join the trial?

The trial requires that you have not started certain medications that affect alcohol consumption, like naltrexone or disulfiram, within 30 days before screening. If you're already on these medications, you might need to stop them to participate.

What prior data suggests that Deep TMS is safe for treating alcoholism?

Research has shown that Deep Transcranial Magnetic Stimulation (Deep TMS) is under study as a treatment for Alcohol Use Disorder (AUD). Some studies have found it can help reduce the urge to drink and lower alcohol consumption. Importantly, these studies reported that patients generally tolerated Deep TMS well.

In one study, participants experienced minimal side effects, mostly mild headaches that resolved on their own. Another study found that Deep TMS did not cause any serious health problems. While not yet approved by the FDA specifically for AUD, Deep TMS has shown promising signs of safety in early research.

Overall, the treatment appears safe with manageable side effects, based on available research. However, as with any medical treatment, individual experiences can vary. Always consult a healthcare provider before starting new treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Deep Transcranial Magnetic Stimulation (Deep TMS) for alcoholism because it offers a non-invasive, brain-focused approach to treatment. Unlike current standard options like medication or behavioral therapy, Deep TMS uses magnetic fields to stimulate specific areas of the brain involved in addiction and cravings. This method could provide a new avenue for reducing alcohol dependence without the side effects often associated with medications. Moreover, it's quick and easy to administer, potentially offering faster results and improving patient compliance.

What evidence suggests that Deep TMS might be an effective treatment for alcoholism?

Research has shown that Deep Transcranial Magnetic Stimulation (Deep TMS) can reduce the urge to drink and the amount of alcohol consumed by people with Alcohol Use Disorder (AUD). In this trial, participants in the treatment group will receive active Deep TMS treatment. One study found that participants who received real Deep TMS treatment had much lower craving scores than those who did not. Another study demonstrated that Deep TMS significantly reduced alcohol use after treatment. These encouraging results suggest that Deep TMS could effectively manage alcohol addiction by lowering both cravings and drinking. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-86 with moderate to severe Alcohol Use Disorder (AUD). Participants must be willing to sign a consent form and have their medical condition assessed. They cannot join if they don't meet the study's specific health requirements, which are not detailed here.

Inclusion Criteria

Subjects diagnosed with AUD and who meet criteria for moderate to severe AUD according to the DSM-5 diagnostic criteria as determined by a licensed clinician and verified with the Mini International Neuropsychiatric Interview

Subjects with a history of at least 24 heavy drinking days during the 90 days prior to screening

Treatment seeking individuals with a treatment goal of achieving abstinence or reducing heavy drinking

Exclusion Criteria

Known or suspected pregnancy or lactation or planning to become pregnant

Women of childbearing potential not using a medically accepted form of contraception when engaging in sexual intercourse

Subjects experiencing acute alcohol withdrawal

Timeline for a Trial Participant

Screening and Baseline

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Treatment

Participants receive 15 treatment visits over a period of 3-5 weeks with either active or sham Deep TMS stimulation

3-5 weeks

15 visits (in-person)

Maintenance Treatment and Follow-up

Participants receive one treatment visit per week until the 6-month follow-up visit, with ongoing assessment of alcohol use and safety monitoring

up to 6 months

Weekly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Deep Transcranial Magnetic Stimulation (Deep TMS)

Trial Overview

The trial compares Deep Transcranial Magnetic Stimulation (Deep TMS) with a sham treatment over six months. It includes three phases: screening/baseline, acute treatment with 15 visits in 3-5 weeks, and weekly maintenance/follow-up treatments until the end of the study.

How Is the Trial Designed?

Group I: Treatment group Experimental Treatment 1 Intervention

The treatment group will receive active, Deep TMS treatment.

Group II: Control group Placebo Group 1 Intervention

The Control group will receive inactive, sham treatment.

Who Is Running the Clinical Trial?

Brainsway

Lead Sponsor

Trials

38

Recruited

2,800+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07216872

NCT07216872 | Safety and Effectiveness of the BrainsWay ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8878126/

rTMS Reduces Craving and Alcohol Use in Patients with ...

These findings suggest that rTMS might be an effective add-on in treating patients with AUD and warrant replication in future large-scale ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2451902225001259

Deep Transcranial Magnetic Stimulation Efficacy in ...

The results showed a significant and large effect of real dTMS in reducing craving scores (SMCC = −1.26; 95% CI, −1.67 to −0.86; p < .001). High ...

4.

recoveryanswers.org

recoveryanswers.org/research-post/transcranial-magnetic-stimulation-alcohol-use-disorder-effects-brain-craving-alcohol-use/

Transcranial magnetic stimulation for alcohol use disorder

This study examined the effects of transcranial magnetic stimulation on brain structure and function, as well as alcohol craving and use, among individuals ...

5.

brainsway.com

brainsway.com/news_events/brainsway-reports-positive-independent-pilot-data-on-accelerated-deep-tms-treatment-of-alcohol-use-disorder/

BrainsWay Reports Positive Independent Pilot Data on ...

In the follow-up period after treatment, subjects receiving accelerated Deep TMS showed notably better improvements when compared to those treated by other ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0006322321018266

Repetitive Transcranial Magnetic Stimulation in Alcohol ...

In a proof-of-concept study, we used deep repetitive transcranial magnetic stimulation (dTMS) to target circuitry associated with the pathophysiology of alcohol ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02691390

Deep Repetitive Transcranial Magnetic Stimulation for ...

Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... Deep Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder.

8.

diva-portal.org

diva-portal.org/smash/get/diva2:1690252/FULLTEXT01.pdf

Alcohol Dependence: A Randomized, Double-Blind, Sham ...

In a proof-of-concept study, we used deep repetitive transcranial magnetic stimulation (dTMS) to target circuitry associated with the pathophysiology of ...