An interventional study of active rTMS and Inpatient admission in Alcohol Use Disorder, sponsored by New York State Psychiatric Institute. Suspended at 1 site in United States. Open to participants aged 22 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 44 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
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Exclusion Criteria:
Participants will be receiving active rTMS.
Device: active rTMS · Behavioral: Inpatient admission
Participants will be receiving sham stimulation with a smaller coil housed within the rTMS device.
Behavioral: Inpatient admission · Device: sham rTMS
rTMS delivers magnetic stimulation to the brain by using an electromagnet to generate a current that can penetrate the scalp and skull.
All subjects will be admitted to the hospital for a brief detoxification period followed by 3 weeks of abstinence.
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.
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.
Time frame: 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.
Time frame: 10 weeks
Change in craving for alcohol measured using the Alcohol Urge Questionnaire (AUQ).
This AUQ (Bohn et al. 1995) is an 8-item self report questionnaire where participants rate a seven-point Likert scale with responses ranging from "strongly disagree" to "strongly agree", and a total score is derived from the sum of these items following reverse scoring of two items. A lower score is a better outcome which represents less desire to drink. Scores range from 8-56.
Time frame: 4 weeks
Change in GABA in the mPFC and ACC as measured with magnetic resonance spectroscopy (MRS).
MRS is performed by using an MRI machine to study metabolites and neurotransmitters in the brain.
Time frame: 4 weeks
Change in abstinence from alcohol following discharge assessed with the Time Line Follow Back Interview.
Time frame: 10 weeks
Changes in cognitive control as measured by using the Frontal Assessment Battery (FAB).
The FAB is a brief tool that discriminates between frontal-temporal type cognitive issues from from Alzheimer's type memory issues. Higher scores are better and scores range from 0-18.
Time frame: 4 weeks
This study is suspended, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute