40 Participants Needed

TMS for Alcohol Use Disorder

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Palo Alto Health Care System
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of this treatment for alcohol use disorder?

Research suggests that repetitive transcranial magnetic stimulation (rTMS) may help reduce alcohol cravings and intake in people with alcohol use disorder. Some studies have shown that rTMS can influence brain activity related to addiction, potentially making it a promising treatment option.12345

Is repetitive transcranial magnetic stimulation (rTMS) safe for humans?

Research suggests that rTMS is generally safe for humans, including those with substance use disorders, although more detailed studies are needed to fully understand its safety in people with varying levels of substance use.45678

How does the treatment TMS differ from other treatments for alcohol use disorder?

Transcranial Magnetic Stimulation (TMS) is unique because it is a non-invasive brain stimulation technique that targets specific brain areas to reduce alcohol cravings and use, unlike traditional treatments that often involve medication or therapy. It uses magnetic fields to stimulate nerve cells in the brain, particularly the dorsolateral prefrontal cortex, which is associated with addiction and cravings.12479

What is the purpose of this trial?

Alcohol Use Disorders are currently positioned as the third leading cause of preventable death in the United States, constituting a humanitarian crisis with substantial financial burden on society and medical facilities. While several pharmacological interventions exist, 60% of individuals who seek these treatments relapse to alcohol within 6 months. These high relapse rates are due in part to elevated brain response to alcohol cues in the environment. This study seeks to evaluate the efficacy of one session of functional Magnetic Resonance Imaging (fMRI) guided transcranial magnetic stimulation (TMS) as a strategy to reduce brain reactivity to alcohol cues.

Research Team

DM

Daniel McCalley, PhD

Principal Investigator

Palo Alto VA Health Care System

Eligibility Criteria

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
My current medication will not change throughout the study.
Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms)
See 3 more

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.
See 9 more

Timeline

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)

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active fMRI-guided TMSExperimental Treatment1 Intervention
Group II: Sham fMRI-guided TMSPlacebo Group1 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

Find a Clinic Near You

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+

Findings from Research

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

References

Efficacy of repetitive transcranial magnetic stimulation in alcohol dependence: a sham-controlled study. [2022]
Modulating Neural Circuits with Transcranial Magnetic Stimulation: Implications for Addiction Treatment Development. [2019]
Deep Transcranial Magnetic Stimulation of the Dorsolateral Prefrontal Cortex in Alcohol Use Disorder Patients: Effects on Dopamine Transporter Availability and Alcohol Intake. [2018]
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. [2023]
Repetitive transcranial magnetic stimulation: Re-wiring the alcoholic human brain. [2020]
Managing substance use in patients receiving therapeutic repetitive transcranial magnetic stimulation: A scoping review. [2023]
Repetitive transcranial magnetic stimulation and drug addiction. [2019]
Effects of repetitive transcranial magnetic stimulation (rTMS) on craving and substance consumption in patients with substance dependence: a systematic review and meta-analysis. [2020]
rTMS Reduces Craving and Alcohol Use in Patients with Alcohol Use Disorder: Results of a Randomized, Sham-Controlled Clinical Trial. [2022]
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