Temporal Interference Methods for Addiction Treatment

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
Indiana University
Study ID
NCT07210268
Status
Recruiting
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Conditions

  • Nicotine Use Disorder
  • Substance Use Disorders

Eligibility Criteria

Sex
ALL
Age
21 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • TI-NDBS — DEVICE
    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 2 mA per electrode, and no single region receives more than 2 mA.
  • Sham TI-NDBS — DEVICE
    This is the control condition in which participants will receive sham stimulation for 60 minutes.

Study Details

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.

Key Dates

Start date
Jan 22, 2026
Status verified
Feb 2026
Primary completion
Feb 20, 2027
Completion
Feb 27, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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 2 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 2 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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana UniversityBloomingtonIndiana47403
Joshua Brown, PhD
[email protected]
812-855-9282

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