NCT07210268 · Indiana University
Temporal Interference Methods for Addiction Treatment
What this study is about
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.
View original scientific 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
DEVICE
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.
DEVICE
Sham TI-NDBS
This is the control condition in which participants will receive sham stimulation for 60 minutes.
Primary outcome measures
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)
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 Session
Time frame: Baseline 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Bloomington, Indiana
- Indianapolis, Indiana
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 15, 2026 · Source of record for eligibility and locations