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

NCT03809286 | Suspended DMC FDA Device

• 3 other identifiers: 76911K23AA0282955R21AA026049
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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). 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.

Conditions

Alcohol Use Disorder

Keywords

rTMS; alcohol use disorder

Outcome Measures

Primary Outcomes (2)

• Change in the choice to self-administer alcohol in the laboratory as assessed by counting the number of drinks consumed in the 2-hour laboratory session.

  Participants will participate in alcohol self-administration sessions in which they are presented with the choice of alcohol or money. The investigators will study the change in choices to choose alcohol during these sessions. There will be one session prior to rTMS and one after 3 weeks of rTMS.

  4 weeks

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.

  Adverse events will be assessed in recorded in accordance with CTCAE v4.0.

  10 weeks

Secondary Outcomes (4)

• Change in craving for alcohol measured using the Alcohol Urge Questionnaire (AUQ).

  4 weeks

• Change in GABA in the mPFC and ACC as measured with magnetic resonance spectroscopy (MRS).

  4 weeks

• Change in abstinence from alcohol following discharge assessed with the Time Line Follow Back Interview.

  10 weeks

• Changes in cognitive control as measured by using the Frontal Assessment Battery (FAB).

  4 weeks

Study Arms (2)

Active Stimulation

EXPERIMENTAL

Participants will be receiving active rTMS.

Device: active rTMS; Behavioral: Inpatient admission

Sham Stimulation

SHAM COMPARATOR

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

Behavioral: Inpatient admission; Device: sham rTMS

Interventions

active rTMS DEVICE

rTMS delivers magnetic stimulation to the brain by using an electromagnet to generate a current that can penetrate the scalp and skull.

Active Stimulation

sham rTMS DEVICE

The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.

Sham Stimulation

Inpatient admission BEHAVIORAL

All subjects will be admitted to the hospital for a brief detoxification period followed by 3 weeks of abstinence.

Active Stimulation; Sham Stimulation

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jonathan Wai

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Addiction Psychiatry Clinical & Research Fellow

Model Details: active vs. sham stimulation

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 18, 2019
• Study Start: June 24, 2019
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)