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Temporal Interference Methods for Addiction Treatment

RecruitingNAAges 21 Years - 50 YearsAllIndiana University
NCT07210268 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This clinical study is testing whether a new non-invasive brain stimulation method, called temporal interference (TI), can reduce nicotine cravings and usage in people who vape. TI delivers mild electrical currents to the scalp in a way that targets deep brain areas involved in addiction, without the need for surgery. In this randomized controlled trial, participants will be assigned to one of three groups: TI stimulation to the nucleus accumbens, TI stimulation to the anterior insula, or a placebo (sham) condition. Each participant will attend a single stimulation session after 8 hours of nicotine abstinence and will use a custom vape device that measures real-time nicotine inhalation. Craving levels will be reported during and after the session. The study aims to determine whether TI to the insula or nucleus accumbens is more effective at decreasing cravings and nicotine inhalation,

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📋 Eligibility rules (as published)
Inclusion Criteria: * Between the ages of 21 and 50 * Nicotine dependent and vape at least 15 mg nicotine per day * Must have a phone with internet access * Participants must have at least a 6th grade education and be able to speak and read English Exclusion Criteria: * History of seizures, seizure disorders, or familial history of seizure disorders * History of intractable migraine or complicated migraine syndromes * History of suicide attempts or active suicidal ideation (past month) * History of cardiac arrhythmias, prolonged QT, pacemakers, or cardiovascular disorders * Hypertension with systolic BP \>150mmHgCentral nervous system structural lesions (tumors, MS, strokes, etc.) * Active neuropsychiatric disorders (schizophrenia, bipolar, active psychosis, dementia, etc.) * History of head trauma with loss of consciousness, skull fractures, subdural hematomas * Active opioid, cocaine, and/or methamphetamine use * Active severe cannabis use disorder * Active alcohol use disorder or history of alcohol withdrawal * Metal implants in the head or under the scalp (excluding dental implants) * Current smoking cessation treatment or medications affecting reward processing * Pregnancy
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What it tests

  • TI-NDBS
  • Sham TI-NDBS
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Where

2 sites
Indiana University
Bloomington, United States
Indiana University School of Medicine - Goodman Hall
Indianapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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