N/A
N=8
Examining the Effectiveness of Deep TMS in Veterans With Alcohol Use Disorder
Alcohol Use Disorder (AUD) · Transcranial Magnetic Stimulation
Bottom Line
View on ClinicalTrials.gov: NCT04927364 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Number of Participants With Relapse to Alcohol 6 Months After Treatment — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Deep Transcranial Magnetic Stimulation (dTMS) H7 coil (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Palo Alto Health Care System
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Relapse to Alcohol 6 Months After Treatment |
3 | — |
| PRIMARY Percentage of Days Abstinent |
85.1 | — |
| PRIMARY Percentage of Days of Heavy Drinking |
2.7 | — |
Summary
This study aims to evaluate the efficacy of deep transcranial magnetic stimulation (dTMS) as a treatment for Veterans with an alcohol use disorder (AUD).
Eligibility Criteria
Inclusion Criteria
- The study will be open to male and females, regardless of race and ethnic origin, 21-70 years of age, who are in active treatment for an AUD at the VAPAHCS, Foundations of Recovery.
- Participants must meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for AUD, and alcohol is self-identified as the primary substance of misuse.
- Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participation in study procedures in English.
- Participants will be accepted if taking medications specifically for the treatment of major depressive disorders, cigarette smoking, or for other psychiatric conditions as long as the medications are not documented to lower seizure threshold - it would be clinically contraindicated to require participants to discontinue such medications for research. rTMS is safely administered to individuals who are taking psychotropic medications that do not lower seizure threshold.
- Participants will be abstinent from alcohol and non-prescribed substances for at least 7 consecutive days prior to rTMS to ensure no participant is experiencing active acute withdrawal.
Exclusion Criteria
Psychiatric:
- Current diagnosis of Schizophrenia Spectrum Disorders and Bipolar Disorders;
- Current moderate-severe substance use disorder other than alcohol, tobacco, or marijuana, based on DSM-5 diagnostic criteria;
- 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 30 minutes, any primary or traumatically induced seizure disorder, and alcohol-related seizure(s) in the past 30 days.
General:
- Lack of fluency in English;
- Wechsler Adult Reading Test below the 7th percentile (i.e., moderate or greater impairment in estimated general intelligence);
- Females who are pregnant or actively attempting pregnancy;
- Conservative exclusion for magnetic resonance research, current use of any medication or substance that is documented to lower seizure threshold or has been identified as a contraindication for rTMS treatment.
Data sourced from ClinicalTrials.gov (NCT04927364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.