Status:
SUSPENDED
The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
22-55 years
Phase:
NA
Brief Summary
The goal of this study is to investigate a treatment approach for alcohol use disorder (AUD) using a novel form of brain stimulation called deep repetitive transcranial magnetic stimulation (rTMS). Th...
Detailed Description
This study aims to examine the effect of rTMS on alcohol drinking behavior in an observed laboratory setting. Participants with AUD will be recruited and admitted to the inpatient unit for the whole s...
Eligibility Criteria
Inclusion
- Current moderate to severe alcohol use disorder, per DSM-5
- Use of alcohol which parallels or exceeds the amount alcohol that will be administered in this study (1 drinking episode per week raising BAL to 0.03 g/dl - approximately 2 drinks within an hour).
- Age 22-55
- Able to give informed consent, and comply with study procedures
- Medically healthy, with the absence of current or past medical or neurological illnesses (including glaucoma, increased intracranial pressure, liver disease, cardiac disease, or seizure disorders)
Exclusion
- Has a contraindication to MRI, such as magnetically reactive implants, which includes metal in head except in mouth (cochlear implant, implanted brain stimulators, aneurysm clips), cardiac pacemakers, implanted neurostimulators and medication pumps, and intracardiac lines.
- Substance use disorder with substances other than alcohol or nicotine. The current use of sedative-hypnotics or opiates will be exclusionary
- Meets DSM-5 criteria for other psychiatric illness, such as major depression, that would interfere with participation.
- History of seizures of any type
- A family history of epilepsy
- Taking psychotropic medication that would affect resting motor threshold (such as anticonvulsants) or increase risk of seizure (especially tricyclic antidepressants of neuroleptics)
- Current suicide risk or a history of suicide attempt within the past 2 years
- Have unstable physical disorders, including those that are previously undiagnosed, untreated, inadequately treated, or active to an extent which might make participation hazardous. For example, hypertension (a resting blood pressure \> 140/90), heart failure, a recent history of myocardial infarction, previous stroke, brain lesions, any history of seizures under any circumstances or low hemoglobin.
- Currently pregnant
- History of severe alcohol withdrawal requiring medical care, such as withdrawal seizures, delirium tremens, withdrawal necessitating medical detoxification.
- A desire to pursue standard treatment for AUD, such as a rehabilitation program or FDA approved medications for AUD
Key Trial Info
Start Date :
June 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03809286
Start Date
June 24 2019
End Date
December 30 2025
Last Update
May 14 2025
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032