TMS for Alcohol Use Disorder

Overseen By Daniel McCalley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Palo Alto Health Care System

Must not be taking: Benzodiazepines, Neuroleptics

Disqualifiers: Substance abuse, Seizure disorder, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist individuals with alcohol use disorder (AUD) using transcranial magnetic stimulation (TMS). TMS is a non-invasive treatment that uses magnetic fields to stimulate the brain and may reduce the urge to drink by calming the brain's response to alcohol cues. Participants will receive either active TMS or a sham (fake) version to compare results. Individuals with a current diagnosis of moderate to severe AUD, who can attend clinic visits and are stable on any medications, might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for AUD.

Will I have to stop taking my current medications?

The trial requires that your current medication regimen remains stable throughout the study. However, you must stop taking any medications that increase seizure risk at least two weeks before treatment.

What prior data suggests that this TMS technique is safe for treating alcohol use disorder?

Research shows that transcranial magnetic stimulation (TMS) is safe and well-tolerated for people with substance use disorders. Studies have found that the side effects of TMS for these individuals are similar to those in other groups, indicating that the treatment rarely causes serious problems.

TMS uses magnetic fields to stimulate the brain. It is non-invasive, requiring no surgery or entry into the body. Research has safely applied this method to conditions like alcohol use disorder. People who have undergone TMS treatment usually experience mild side effects, such as headaches or a tingling sensation in the head. These effects are typically temporary and do not cause long-term issues.

Overall, TMS has a strong record of safety and manageability for patients. This is encouraging for anyone considering participation in a clinical trial involving TMS for alcohol use disorder. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) for Alcohol Use Disorder is unique because it offers a non-invasive approach that targets brain activity directly. Unlike traditional treatments like medications and behavioral therapies, TMS uses magnetic fields to stimulate nerve cells in the brain, potentially reducing cravings and withdrawal symptoms. Researchers are excited about TMS because it could offer a faster, more precise way to address the neurological aspects of addiction, providing an alternative for patients who haven't responded well to existing therapies. Additionally, the use of fMRI guidance in this trial allows for a tailored approach, potentially improving the effectiveness and outcomes of the treatment.

What evidence suggests that fMRI-guided TMS is effective for reducing brain reactivity to alcohol cues?

This trial will compare the effects of Active fMRI-guided TMS with Sham fMRI-guided TMS for alcohol use disorder. Studies have shown that transcranial magnetic stimulation (TMS) can help reduce drinking in people with this condition. Some research found that individuals who received TMS experienced fewer days of heavy drinking. Another study found that TMS might alter the brain's response to alcohol-related triggers, potentially reducing cravings. Traditional treatments often lead to relapse, but TMS offers a new approach by directly affecting brain activity. Early results suggest it could be a promising tool for reducing alcohol dependence. ^{1 2 6 7 8}

Who Is on the Research Team?

Daniel McCalley, PhD

Principal Investigator

Palo Alto VA Health Care System

Are You a Good Fit for This Trial?

This trial is for individuals struggling with Alcohol Use Disorder. Participants should have a history of alcoholism and be seeking treatment. Specific details about inclusion and exclusion criteria are not provided, but typically these would outline health conditions, age range, and other factors relevant to the study.

Inclusion Criteria

Able to read, understand and voluntarily sign Informed Consent prior to participating in any study-specific procedures or assessments

Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms)

Fluency in English

Exclusion Criteria

General medical condition, disease or neurological disorder that interferes with the assessments or participation

Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to follow study protocols

I have had a brain injury with more than 10 minutes of unconsciousness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one session of fMRI-guided TMS targeting peak functional connectivity to the ventral striatum

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in brain reactivity to alcohol cues post-TMS

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview The study is testing the effectiveness of transcranial magnetic stimulation (TMS), guided by brain imaging (fMRI), in reducing the brain's response to alcohol-related cues which can lead to relapse in people with Alcohol Use Disorder.

How Is the Trial Designed?

Group I: Active fMRI-guided TMS Experimental Treatment 1 Intervention

Group II: Sham fMRI-guided TMS Placebo Group 1 Intervention

Transcranial Magnetic Stimulation is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder
• Obsessive Compulsive Disorder

Approved in Canada as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Approved in European Union as Transcranial Magnetic Stimulation for:

• Major Depressive Disorder

Who Is Running the Clinical Trial?

VA Palo Alto Health Care System

Lead Sponsor

Trials

97

Recruited

58,500+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Transcranial magnetic stimulation (TMS) is emerging as a promising noninvasive treatment for substance dependence, potentially filling a gap in addiction therapies, as it is already FDA-approved for depression.

Repetitive TMS (rTMS) has shown potential in altering behavior and brain activity related to addiction, and future studies may benefit from combining rTMS with medications and cognitive behavioral therapies to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulating Neural Circuits with Transcranial Magnetic Stimulation: Implications for Addiction Treatment Development. Hanlon, CA., Dowdle, LT., Henderson, JS.[2019]

In a pilot study involving 14 patients with alcohol use disorder (AUD), deep repetitive Transcranial Magnetic Stimulation (rTMS) of the dorsolateral prefrontal cortex led to a significant reduction in dopamine transporter (DAT) availability and alcohol intake after four weeks of treatment.

The results suggest that rTMS may modulate dopaminergic activity, indicating its potential efficacy as a therapeutic intervention for reducing alcohol consumption in AUD patients, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex in Alcohol Use Disorder Patients: Effects on Dopamine Transporter Availability and Alcohol Intake. Addolorato, G., Antonelli, M., Cocciolillo, F., et al.[2018]

Repetitive transcranial magnetic stimulation (rTMS) is emerging as a promising and safe treatment for alcohol use disorders (AUDs), potentially addressing the limited therapeutic options currently available.

rTMS may work by altering neurocircuitries related to alcohol addiction, with evidence from visual imaging studies and clinical pilot studies showing its effects on reducing alcohol craving and intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation: Re-wiring the alcoholic human brain. Diana, M., Bolloni, C., Antonelli, M., et al.[2020]

Excitatory repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral pre-frontal cortex significantly reduces craving for substances in patients with dependence, with a strong effect size (Hedges' g = -0.62) based on a meta-analysis of 26 randomized controlled trials involving 748 participants.

In addition to reducing cravings, rTMS also effectively decreases substance consumption, particularly when using excitatory stimulation protocols, indicating its potential as a therapeutic intervention for substance dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. Zhang, JJQ., Fong, KNK., Ouyang, RG., et al.[2020]

In a study involving 80 detoxified patients with alcohol use disorder, 10 sessions of high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) did not significantly increase the number of abstinent days over a 6-month follow-up compared to a sham treatment.

HF-rTMS also showed no impact on alcohol craving levels, indicating that this treatment may not be effective as an add-on therapy for reducing alcohol use or cravings in patients with alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 10 add-on HF-rTMS treatment sessions on alcohol use and craving among detoxified inpatients with alcohol use disorder: a randomized sham-controlled clinical trial. Hoven, M., Schluter, RS., Schellekens, AF., et al.[2023]

High-frequency repetitive transcranial magnetic stimulation (rTMS) targeting the right dorsolateral pre-frontal cortex significantly reduced alcohol craving in 45 patients with alcohol dependence, demonstrating its potential as an effective treatment strategy.

The study showed a moderate effect size for the anticraving effects of rTMS, suggesting that it could be combined with other medications to further reduce cravings and prevent relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. Mishra, BR., Nizamie, SH., Das, B., et al.[2022]

Repetitive Transcranial Magnetic Stimulation (rTMS) is generally safe and feasible for patients with neuropsychiatric disorders who also have a history of substance use, based on a review of 274 articles.

However, the impact of different levels of substance use on the safety and efficacy of rTMS remains unclear, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing substance use in patients receiving therapeutic repetitive transcranial magnetic stimulation: A scoping review. Tang, VM., Ibrahim, C., Rodak, T., et al.[2023]

In a study involving 30 recently detoxified patients with alcohol use disorder, high-frequency rTMS applied over the right dorsolateral prefrontal cortex significantly reduced alcohol craving and use during the first three months after treatment compared to a sham treatment.

However, the effects of rTMS on craving and alcohol use diminished by the 12-month follow-up, indicating that while rTMS may be a beneficial short-term add-on treatment for alcohol use disorder, its long-term efficacy needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

rTMS Reduces Craving and Alcohol Use in Patients with Alcohol Use Disorder: Results of a Randomized, Sham-Controlled Clinical Trial. Belgers, M., Van Eijndhoven, P., Markus, W., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) has shown effectiveness in reducing cravings for tobacco, alcohol, and cocaine when applied at high frequencies to the dorsolateral prefrontal cortex (DLPFC), based on a review of eight studies.

Repeated sessions of high-frequency rTMS over the DLPFC may be particularly beneficial for decreasing smoking and alcohol consumption, suggesting that rTMS could be a promising treatment option for drug addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation and drug addiction. Barr, MS., Farzan, F., Wing, VC., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35022086/

study protocol for a randomized controlled trial The main outcomes of the study will be changes in alcohol consumption within the 4 weeks after the rTMS sessions. Secondary outcome measures ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0006322321018266

Repetitive Transcranial Magnetic Stimulation in Alcohol ... Each session delivered 100 trains of 30 pulses at 10 Hz. The primary predefined outcome was reduction in percentage of heavy drinking days, obtained using ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4202564/

Repetitive Transcranial Magnetic Stimulation (rTMS) in the ... Therefore, the purpose of this review is to critically evaluate the efficacy of TMS in the treatment of alcohol dependence and other substance abuse disorders.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03910686

Efficacy of Repetitive Transcranial Magnetic Stimulation ... Although many efforts had been made in the treatment of alcohol dependence, the annual recurrence of alcohol dependence with traditional therapies was over 45%.

5. 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 ...

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05940-z

Efficacy of repetitive transcranial magnetic stimulation (rTMS ... Several studies have observed a beneficial effect of rTMS on substance use disorders by reducing craving, impulsivity, and risk-taking behavior ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835319

Repetitive Transcranial Magnetic Stimulation as ... The relapse prevention success rate at 24 weeks in the rTMS monotherapy group was approximately 85%, whereas prior literature indicates that the ...

8. brainstimjrnl.com brainstimjrnl.com/article/S1935-861X(25)00373-0/fulltext

Evidence for Safety and Tolerability of Transcranial Magnetic ... TMS is safe and well-tolerated for people with SUDs. The prevalence of side effects from TMS in people with SUDs is comparable to that in the ...