Recruiting

Temporal Interference

Sponsor:

Indiana University

Code:

NCT07210268

Conditions

Nicotine Use Disorder

Substance Use Disorders

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

Interventions

TI-NDBS

Sham TI-NDBS

Study Details

Brief summary:

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.

Conditions

Nicotine Use Disorder

Substance Use Disorders

Study ID

NCT07210268

Start date

Jan 22, 2026

Status verified date

Feb, 2026

Completion date

Feb 27, 2027

Anticipated

Primary completion date

Feb 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TI Stimulation - Nucleus Accumbens

Participants in this arm will receive 60 minutes of temporal interference (TI) stimulation targeted to the nucleus accumbens (NAcc). TI will be delivered using two electrode sets, with placement determined to optimize stimulation of this region. Stimulation will use up to 5 mA per electrode at carrier frequencies of 2000 Hz and 2020 Hz, producing a 20 Hz beat frequency. Craving ratings will be collected every 10 minutes, and nicotine vapor use will be measured in real time.

experimental: TI Stimulation - Anterior Insula

Participants in this arm will receive 60 minutes of temporal interference (TI) stimulation targeted to the anterior insula (AI). TI will be delivered using two electrode sets, with placement determined to optimize stimulation of this region. Stimulation will use up to 5 mA per electrode pair at carrier frequencies of 2000 Hz and 2020 Hz, producing a 20 Hz beat frequency. Craving ratings will be collected every 10 minutes, and nicotine vapor use will be measured in real time.

sham comparator: Sham Stimulation

Participants in this arm will receive sham temporal interference (TI) stimulation that mimics the initial sensation of active stimulation. The current will ramp up over 30 seconds and immediately ramp back down, with no sustained current. This procedure controls for sensory experience and participant expectations. Electrode placement will mirror that used in the active conditions. Participants will complete the same craving assessments and use the same custom vape device as in the experimental arms.

Interventions

TI-NDBS

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

This is the control condition in which participants will receive sham stimulation for 60 minutes.

Primary outcome measure

  • Change in Nicotine Craving From Baseline to End of Stimulation Session [ Time Frame: Baseline to 60 minutes post-stimulation initiation (during the single stimulation session) ]
  • Change in Nicotine Vapor Inhalation Volume From Baseline to End of 60-Minute Stimulation Session [ Time Frame: Baseline to 60 minutes post-stimulation initiation ]

Central Contacts and Locations

Central contacts

Joshua Brown, PhD

812-855-9282jwmbrown@iu.edu

Kendall Moore, BS

(812) 856-1846kem12@iu.edu

Locations

Indiana University

Recruiting

Bloomington, Indiana, United States, 47403

Contacts

Joshua Brown, PhD

812-855-9282jwmbrown@iu.edu

Indiana University School of Medicine - Goodman Hall

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Joshua w Brown, PhD

8128559282jwmbrown@iu.edu

Principal Investigator:

Joshua W Brown, Phd

More Information

Sponsor

Indiana University

Last update posted

Jul 15, 2026

Last verified

Feb, 2026

Keywords

  • Nicotine Addiction
  • Non-invasive deep brain stimulation
  • Substance Use Disorders
  • Temporal Interference Stimulation
  • BOLD Activation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Indiana University on 2026-07-15.