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

Qualifiers

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

Treatments tested in this trial

  • TI-NDBS
  • Sham TI-NDBS

Treatment groups

120 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Indiana University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator