Temporal Interference for Nicotine Use Disorder

This study is testing a new non-invasive brain stimulation method called temporal interference (TI-NDBS) to see if it can help reduce nicotine cravings and use in people who vape. TI-NDBS uses mild electrical currents delivered through scalp electrodes to target deep brain areas involved in addiction. You would be assigned to one of three groups: TI-NDBS targeting the nucleus accumbens, TI-NDBS targeting the anterior insula, or a sham (placebo) condition. The main goals are to see how much nicotine craving changes and how much nicotine you inhale during a single 60-minute stimulation session. This study is looking for 120 participants aged 21-50 who vape at least 15 mg of nicotine daily and meet other criteria.

Study design
This is an interventional study with a planned enrollment of 120 participants. It is a randomized controlled trial, meaning participants will be assigned by chance to one of three groups.
What's involved
You would attend a single 60-minute stimulation session after 8 hours of nicotine abstinence. You will use a special vape device that measures nicotine inhalation and report your craving levels during and after the session.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured from baseline to 60 minutes post-stimulation initiation, during the single stimulation session.

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NCT07210268

Temporal Interference Methods for Addiction Treatment

Recruiting
NAAges 21–50InterventionalTreatment
Indiana University
~120 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:TI-NDBSSham TI-NDBS

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Nicotine Craving From Baseline to End of Stimulation Session
Measured over Baseline to 60 minutes post-stimulation initiation (during the single stimulation session)
+1 more outcome measured
Nicotine Use Disorder
Substance Use Disorders
2 sites across 1 states
Indiana2
  • Joshua Brown · PRINCIPAL_INVESTIGATOR · Indiana University, Bloomington

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Eligibility criteria

Inclusion

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

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
  • Change in Nicotine Craving From Baseline to End of Stimulation SessionBaseline to 60 minutes post-stimulation initiation (during the single stimulation session)

    Nicotine craving will be assessed using a 1-10 Likert scale (1 = no craving, 10 = extremely strong craving) administered every 10 minutes during the 60-minute temporal interference (TI) stimulation session. The primary outcome is the change in self-reported craving from baseline (pre-stimulation) to the final rating at the 60-minute time point. This measure will assess the immediate effect of TI stimulation targeting either the nucleus accumbens or anterior insula on nicotine craving relative to sham stimulation.

  • Change in Nicotine Vapor Inhalation Volume From Baseline to End of 60-Minute Stimulation SessionBaseline to 60 minutes post-stimulation initiation

    Nicotine use will be assessed using a custom vape device that continuously measures the volume of inhaled vapor during the 60-minute stimulation session. The primary outcome is the change in total vapor volume compared to baseline, assessed across all three groups (NAcc, anterior insula, and sham).