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

New York State Psychiatric Institute

Status: Suspended

Conditions: Alcohol Use Disorder

Treatments: Device: sham rTMS; Behavioral: Inpatient admission; Device: active rTMS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03809286

1K23AA028295 (U.S. NIH Grant/Contract)

5R21AA026049 (U.S. NIH Grant/Contract)

7691

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 22 to 55 years old

Volunteers: No Healthy Volunteers

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 22-55
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.
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

44 participants in 2 patient groups

Active Stimulation

Experimental group

Description:

Participants will be receiving active rTMS.

Treatment:

Device: active rTMS

Behavioral: Inpatient admission

Sham Stimulation

Sham Comparator group

Description:

Participants will be receiving sham stimulation with a smaller coil housed within the rTMS device.

Treatment:

Behavioral: Inpatient admission

Device: sham rTMS