The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:22 - 50
Updated:1/20/2019
Start Date:January 2019
End Date:December 2021
Contact:Jonathan Wai, MD
Email:jonathan.wai@nyspi.columbia.edu
Phone:646-774-5819

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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). The investigators will be targeting frontal regions of the brain that are
important for memory and decision making. These brain regions have been shown to be impaired
in patients with AUD. Previous studies have mostly used rTMS to a different frontal brain
region that is not as deep. These studies have shown that rTMS can reduce craving for
alcohol, but there is a lack of research showing that rTMS impacts alcohol consumption.

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 study. After a brief detoxification period, they will receive 3 weeks of
rTMS while in the research unit. Before and after the 3 weeks of stimulation, participants
will participate in a decision-making experiment where they can choose to have an alcoholic
drink or the equivalent amount of money that the drink would cost (alcohol
self-administration sessions). The investigators will examine their response to alcohol, as
well as their performance on tasks that relate to impulsivity and memory. Participants will
also undergo an MRI scan (with spectroscopy) before and after the stimulation period to look
at changes in the medial prefrontal cortex of the brain. Participants will then meet with a
study physician for 6 weeks after the study for assessments of alcohol use and medical
management sessions.

Inclusion Criteria:

1. Current moderate to severe alcohol use disorder, per DSM-5

2. 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).

3. Age 22-50

4. Able to give informed consent, and comply with study procedures

5. 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 Criteria:

1. 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.

2. Substance use disorder with substances other than alcohol or nicotine. The current use
of sedative-hypnotics or opiates will be exclusionary

3. Meets DSM-5 criteria for other psychiatric illness, such as major depression, that
would interfere with participation.

4. History of seizures of any type

5. A family history of epilepsy

6. Taking psychotropic medication that would affect resting motor threshold (such as
anticonvulsants) or increase risk of seizure (especially tricyclic antidepressants of
neuroleptics)

7. Current suicide risk or a history of suicide attempt within the past 2 years

8. 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 (<11 g/dl for
females, < 13 g/dl for males).

9. Currently pregnant

10. History of severe alcohol withdrawal requiring medical care, such as withdrawal
seizures, delirium tremens, withdrawal necessitating medical detoxification.

11. A desire to pursue standard treatment for AUD, such as a rehabilitation program or FDA
approved medications for AUD
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
646-774-5000
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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mi
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New York, NY
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