Temporal Interference for Nicotine Use Disorder
This study is testing a new non-invasive brain stimulation method called temporal interference (TI-NDBS) to see if it can help reduce nicotine cravings and use in people who vape. TI-NDBS uses mild electrical currents delivered through scalp electrodes to target deep brain areas involved in addiction. You would be assigned to one of three groups: TI-NDBS targeting the nucleus accumbens, TI-NDBS targeting the anterior insula, or a sham (placebo) condition. The main goals are to see how much nicotine craving changes and how much nicotine you inhale during a single 60-minute stimulation session. This study is looking for 120 participants aged 21-50 who vape at least 15 mg of nicotine daily and meet other criteria.
- Study design
- This is an interventional study with a planned enrollment of 120 participants. It is a randomized controlled trial, meaning participants will be assigned by chance to one of three groups.
- What's involved
- You would attend a single 60-minute stimulation session after 8 hours of nicotine abstinence. You will use a special vape device that measures nicotine inhalation and report your craving levels during and after the session.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured from baseline to 60 minutes post-stimulation initiation, during the single stimulation session.
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Temporal Interference Methods for Addiction Treatment
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Joshua Brown · PRINCIPAL_INVESTIGATOR · Indiana University, Bloomington
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Nicotine Craving From Baseline to End of Stimulation SessionBaseline 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 SessionBaseline 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).