Temporal interference stimulation for nicotine vaping addiction
Temporal Interference Methods for Addiction Treatment
NA · Indiana University · NCT07210268
This trial will test whether a non-invasive brain stimulation method called temporal interference can lower cravings and reduce vaping in adults who use nicotine.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 1 site (Bloomington, Indiana) |
| Trial ID | NCT07210268 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 21–50 who are nicotine-dependent vapers (≥15 mg nicotine per day), can read English, have a phone with internet access, and can abstain from nicotine for at least 8 hours are the intended participants.
Not a fit: People with a history of seizures, active severe psychiatric or neurological disorders, significant cardiac problems, or active use of opioids, cocaine, or methamphetamine are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, TI could offer a non-surgical way to rapidly reduce nicotine craving and vaping, potentially expanding treatment options for people who vape.
How similar studies have performed: Invasive deep brain stimulation of the nucleus accumbens and insula has produced strong reductions in addictive behavior in case reports, and pilot TI work shows target activation on fMRI, but TI for addiction remains novel and not yet proven in larger clinical trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bloomington, Indiana
- Indiana University — Bloomington, Indiana, United States (RECRUITING)
Study contacts
- Principal investigator: Joshua Brown — Indiana University, Bloomington
- Study coordinator: Joshua Brown, PhD
- Email: jwmbrown@iu.edu
- Phone: 812-855-9282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nicotine Use Disorder, Substance Use Disorders, Nicotine Addiction, Non-invasive deep brain stimulation, Temporal Interference Stimulation, BOLD Activation