Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT03191266
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
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
* 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
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT03191266
Study Brief:
Protocol Section:
NCT03191266