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

NCT03191266 | Completed Results DMC FDA Device

• 2 other identifiers: D2303-R1I01RX002303-01A2
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Keywords

repetitive transcranial magnetic stimulation; alcohol use disorder; neuroimaging; relapse; Veterans

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Abstained From Alcohol

  For the 6 months following completion of active or sham rTMS treatment, participants were contacted monthly, via telephone or in person, to complete a brief standardized measure of alcohol and substance use, and psychiatric symptoms to assess for changes in these variables over the previous 30 days.

  6 months following last TMS session

Secondary Outcomes (3)

• Glutamate Concentration in the Left Dorsolateral Prefrontal Cortex (as Measured With Single Voxel Spectroscopy)

  Baseline

• Volume in Anterior Frontal Cortical Regions (as Measured With FreeSurfer)

  Baseline

• BDNF Polymorphisms (as Measured With TaqMan Genotyping Assays or Similar Assays)

  Baseline

Study Arms (2)

active rTMS

ACTIVE COMPARATOR

Active rTMS will receive an intermittent rTMS stimulation protocol.

Device: Active rTMS

sham rTMS

SHAM COMPARATOR

Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.

Device: Sham rTMS

Interventions

Active rTMS DEVICE

Active rTMS will receive an intermittent rTMS stimulation protocol.

active rTMS

Sham rTMS DEVICE

Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.

sham rTMS

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

Related Publications (1)

• Durazzo TC, McNerney MW, Hansen AM, Gu M, Sacchet MD, Padula CB. BDNF rs6265 Met carriers with alcohol use disorder show greater age-related decline of N-acetylaspartate in left dorsolateral prefrontal cortex. Drug Alcohol Depend. 2023 Jul 1;248:109901. doi: 10.1016/j.drugalcdep.2023.109901. Epub 2023 Apr 28.

  PMID: 37146499 DERIVED

MeSH Terms

Conditions

Alcoholism; Recurrence

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to the extended halt of human subject recruitment during the COVID-19 pandemic, and the Principal Investigator's (TCD) 1.5 year active duty military deployment during the study recruitment phase, the sample size was lower than the 100 used to power the current study.

Results Point of Contact

• Title: Dr. Timothy C. Durazzo
• Organization: VA Palo Alto Health Care System

tdurazzo@stanford.edu

650-493-5000

Study Officials

• Timothy C. Durazzo, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A double-blind randomized clinical trial with two groups: Active rTMS Treatment Group (Active rTMS) - will receive four to five treatments (two treatments per day) each week for 2 weeks. Sham Control Treatment group (i.e., identical rTMS experimental procedure, but no active stimulation) will receive the same frequency and duration of rTMS sessions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: A double-blind randomized clinical trial with two groups: Active rTMS Treatment Group (Active rTMS) - will receive four to five treatments (two treatments per day) each week for 2 weeks. Sham Control Treatment group (i.e., identical rTMS experimental procedure, but no active stimulation) will receive the same frequency and duration of rTMS sessions. The proposed rTMS protocol is consistent with the FDA approved treatment regimen employed for major depressive disorders.

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 19, 2017
• Study Start: April 15, 2018
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: January 28, 2026
• Results First Posted: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)