Temporal Interference Methods for Addiction Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-50
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
TI-NDBS
DeviceIn 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
DeviceThis is the control condition in which participants will receive sham stimulation for 60 minutes.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: TI Stimulation - Nucleus AccumbensExperimental treatment 1 intervention
Group B: TI Stimulation - Anterior InsulaExperimental treatment 1 intervention
Group C: Sham StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Nicotine Craving From Baseline to End of 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.
Time frame
Baseline to 60 minutes post-stimulation initiation (during the single stimulation session)2
Change in Nicotine Vapor Inhalation Volume From Baseline to End of 60-Minute Stimulation Session
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).
Time frame
Baseline to 60 minutes post-stimulation initiationSecondary outcomes
1
Change in Self-Reported Nicotine Craving Over 7-Day Post-Stimulation Period
Participants will report nicotine craving levels three times daily using ecological momentary assessment (EMA) via a smartphone app for seven days following the stimulation session. Ratings will use a 1-10 Likert scale, and group differences will be analyzed to assess lasting effects of stimulation.
Time frame
Daily for 7 days post-stimulation2
Change in Self-Reported Nicotine Use Frequency Over 7-Day Post-Stimulation Period
Participants will self-report frequency of nicotine vaping or cigarette use three times daily via EMA for 7 days following the stimulation session. Daily use will be compared across groups to assess sustained effects on nicotine consumption.
Time frame
Daily for 7 days post-stimulationOther outcomes
1
Change in Cognitive Function (Digit Span Test) From Pre- to Post-Stimulation
Cognitive function will be assessed before and after stimulation using the Digit Span subtest from the Wechsler Adult Intelligence Scale (WAIS-IV). This will evaluate short-term effects of TI stimulation on memory and attention.
Time frame
Immediately before to 10 minutes after stimulation sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov