Transcranial Magnetic Stimulation for the Treatment of Veterans With Alcohol Use Disorders

Completed · Not applicable · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

At least 60% of Veterans with an alcohol use disorder will relapse within 6 months of treatment, irrespective of the type of treatment they receive. This indicates that currently available interventions for treating AUD in Veterans are not effective in helping them achieve long-term sobriety. Repetitive transcranial magnetic stimulation (rTMS) is a brain stimulation method that is at the forefront of innovative, non-invasive, and safe treatments for AUD. However, there have been no studies that specifically determined the effectiveness of rTMS treatment for Veterans with AUD. This project will evaluate the effectiveness of rTMS treatment in promoting long-term abstinence in Veterans suffering from AUD. Assisting Veterans in achieving long-term and sustained sobriety is critical because it is associated with the best medical, cognitive, psychiatric, and psychosocial recovery from AUD.

Key facts

Study ID

NCT03191266

Run by

VA Office of Research and Development

People needed

49

Starts

2018-04-15

Expected to finish

2024-06-28

Last updated by the study team

2026-01-28

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The study will be open to male and females, regardless of race and ethnic origin, who are in active treatment for an alcohol use disorder (AUD).
• Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for AUD, and alcohol is self-identified as primary substance of misuse.
• Actively in treatment at VA Palo Alto HCS Addiction Treatment Service, and able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participation in study procedures.
• Participants will be accepted if taking medications specifically for the treatment of MDD, cigarette smoking, or for other psychiatric conditions.
• as long as the medications are not documented to lower seizure threshold
• must be stable on any psychotropic medication for at least 1 month prior to enrollment
• it would be clinically contraindicated to require participants to discontinue such medications for research.
• Participants will be abstinent from alcohol and non-prescribed substances for at least 7 consecutive days prior to active or sham rTMS and no participant demonstrates active acute withdrawal symptoms.

You may not qualify if…

• Psychiatric:
• History of Schizophrenia Spectrum Disorders
• Bipolar Disorders
• A current substance use disorder that exceeds the severity of the AUD
• based on DSM-5 diagnostic criteria
• Current use of an FDA approved medication for treatment of AUD, i.e.:
• disulfiram
• acamprosate
• naltrexone
• Active current suicidal intent or plan
• patients with a previous clinical flag for risk for suicide will be required to have an established safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial
• Any form of previous rTMS or electroconvulsive treatment
• Biomedical:
• Including but not limited to uncontrolled thyroid disease
• Unstable congestive heart failure
• Angina
• Other severe cardiac illness as defined by treatment regimen changes in the prior 3 months
• Cerebrovascular accident
• Cancer if < 1 year since end of treatment
• Unstable diabetes
• COPD requiring oxygen supplementation
• Alzheimer's disease
• Parkinson's disease
• Any biomedical implants with ferromagnetic content
• Neurostimulation devices

Where it is running

• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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