Temporal interference stimulation for nicotine vaping addiction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled trial will enroll 120–150 nicotine-dependent adults who vape and randomize them to TI targeting the nucleus accumbens, TI targeting the anterior insula, or a sham condition. After at least 8 hours of nicotine abstinence, participants will undergo a single 60-minute stimulation session while using a custom vape device that records real-time inhalation and provide craving ratings during and after stimulation, with use monitored for one week. Temporal interference delivers intersecting high-frequency scalp currents that create a low-frequency envelope aimed at stimulating deep brain regions without surgery, and prior pilot work has shown TI can activate the nucleus accumbens on fMRI. The trial compares whether stimulation of the insula or nucleus accumbens reduces craving and nicotine inhalation more than sham.

Why it matters

Who can join: the full rules

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

Where it's running

• Indiana University
  Bloomington, Indiana, United States Recruiting
• Indiana University School of Medicine - Goodman Hall
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Joshua Brown — Indiana University, Bloomington
• Study coordinator: Joshua Brown, PhD
• Email: cclab@iu.edu
• Phone: 812-855-9282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.