Intermittent Theta Burst for the Treatment of Alcohol Use Disorders in Veterans

Conditions:Depression, Depression, Smoking Cessation, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Age Range:21 - 65
Start Date:December 1, 2017
End Date:December 1, 2019
Contact:Timothy C Durazzo, PhD

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Intermittent Theta Burst TMS for the Treatment of Alcohol Use Disorders in Veterans

The purpose of this study is to evaluate the efficacy of intermittent theta burst repetitive
transcranial magnetic stimulation (iTBS) as a treatment for Veterans with an alcohol use
disorder (AUD) to decrease the exceedingly high rate of relapse associated with this
condition. iTBS has demonstrated equivalent efficacy and safety to repetitive transcranial
magnetic stimulation employing 10Hz stimulation protocols in treatment of depressive
disorders. The advantage of iTBS is that it can be delivered in approximately 5 minutes where
conventional 10Hz repetitive transcranial magnetic stimulation (rTMS) protocols are typically
20-25 minutes. It is hypothesized that Veterans with AUD who receive active iTBS applied to
the left dorsolateral prefrontal cortex (DLPFC), compared to controls (i.e., Veterans with
AUD who receive sham iTBS), will show significant decreases alcohol craving, depressive
symptomatology and cigarette consumptions, as well as improved neurocognition, a longer
period of abstinence, and a lower overall rate of relapse over 6 months following standard
psychosocial treatment for AUD at VA substance treatment clinics. In exploratory analyses, it
is also predicted that magnetic resonance measures of left DLPFC glutamate concentration,
volume of anterior frontal cortical brain regions, and performance on fMRI tasks
interrogating the function of the salience/reward circuits will serve as biomarkers of iTBS
treatment response. The goal of this proposal is to implement treatment that effectively
promotes sustained abstinence in Veterans with AUD, given long-term abstinence is related to
optimal neurobiological, neuropsychological and psychosocial recovery and functioning.

Inclusion Criteria:

- 21-65 years of age

- Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
criteria for alcohol use disorder, and alcohol is self-identified as primary substance
of misuse.

- Actively in treatment at VA Palo Alto HCS Addiction Treatment Service

- Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form
prior to participation in study procedures.

Exclusion Criteria:

- 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 (i.e., disulfiram, acamprosate, and
naltrexone) for treatment of AUD,

- 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 TMS or electroconvulsive treatment.

- 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, cardiac pacemakers or any magnetic resonance

- Traumatic brain injury with self-reported or observed loss of consciousness > 30

- Any primary or traumatically induced seizure disorder

- 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 TMS treatment.
We found this trial at
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
Stanford, CA
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Palo Alto, California 94304
Phone: 650-493-5000
Palo Alto, CA
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