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RECRUITING Not applicable ClinicalTrials.gov

Temporal Interference Methods for Addiction Treatment

Sponsor: Indiana University • ClinicalTrials.gov ID: NCT07210268

Registry updated: 2026-09-11
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Description

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, and whether either is more effective than sham stimulation. For one week after the session, participants will use a smartphone app to track nicotine use and cravings. The primary hypothesis is that TI stimulation to deep brain regions will reduce both nicotine craving and actual use, immediately after stimulation and over the following week, compared to the sham condition.

Interventions

  • TI-NDBS (Device)
    In the active TI-NDBS condition, participants receive transcranial stimulation for 60 minutes through scalp electrodes using temporal interference (TI). Two electrode sets deliver high-frequency alternating currents (e.g., 2000 Hz and 2020 Hz), generating a 20 Hz beat frequency at depth to stimulate targeted brain regions. Stimulation is delivered in six 10-minute blocks with 30-second ramp-up and ramp-down periods to minimize discomfort. Electrode configurations differ by group to target either the nucleus accumbens or anterior insula, based on finite element modeling. The maximum current is up to 5 mA per electrode, and no single region receives more than 5 mA.
  • Sham TI-NDBS (Device)
    This is the control condition in which participants will receive sham stimulation for 60 minutes.

Eligibility criteria

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

Conditions

Nicotine Use Disorder Substance Use Disorders

Locations

  • Indiana University — Bloomington, Indiana, United States
  • Indiana University School of Medicine - Goodman Hall — Indianapolis, Indiana, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record