Status:
TERMINATED
Intermittent Theta Burst for the Treatment of Alcohol Use Disorders in Veterans
Lead Sponsor:
Stanford University
Conditions:
Alcohol Use Disorder
Depressive Disorder
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 contraindications
- Traumatic brain injury with self-reported or observed loss of consciousness \> 30 minutes
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03291431
Start Date
December 1 2017
End Date
July 30 2022
Last Update
October 16 2023
Active Locations (2)
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1
Palo Alto VA Health Care System
Palo Alto, California, United States, 94304
2
Stanford University
Stanford, California, United States, 94305