Using non-invasive brain stimulation to reduce nicotine cravings
Temporal Interference Neurostimulation and Addiction
This study is testing a new brain stimulation technique to see if it can help adults with nicotine addiction reduce their cravings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Bloomington, Indiana) |
| Trial ID | NCT04432064 on ClinicalTrials.gov |
What this trial studies
This project aims to explore the use of temporal interference non-invasive deep brain stimulation (TI-NDBS) to treat adults with nicotine use disorders. The study will identify optimal brain regions for stimulation and assess the effects on drug cravings and behavior. It will compare TI-NDBS with traditional transcranial direct current stimulation (tDCS) and sham stimulation across four phases, focusing on feasibility and effectiveness. The ultimate goal is to gather data to support future NIH-sponsored clinical trials for addiction treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 40 who smoke at least three-quarters of a pack of cigarettes daily and can read and speak English.
Not a fit: Patients with a history of seizure disorders, neurological conditions, or those on certain psychotropic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for individuals struggling with nicotine addiction.
How similar studies have performed: Previous studies have shown some success in reducing cravings with tDCS, but TI-NDBS is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be between the ages of 18 and 40, must have at least 6th grade education, and the ability to speak and read English, must smoke at least 3/4 of a pack of cigarettes per day, must have phone with internet access. Exclusion Criteria: * if they are on psychotropic medications for ADHD, other mental illness or medication for cancer, epilepsy (i.e. individuals with any history of seizure disorder), migraines, or other neurological syndromes, or AIDs (which can cause cognitive deficits (Watkins \& Treisman, 2015), history of head trauma, history of cognitive impairments, metal implants in the head or under the scalp, personal experiences consistent with symptoms of psychosis (i.e. mind or body being secretly controlled, special powers, seeing or hearing things that aren't really there). * Subjects will be excluded if they do not meet fMRI safety screening criteria (i.e. metal implants in their body, tattoo on head or neck, permanent jewelry, etc.) or if a participant uses an IUD for birth control they will be excluded unless the subject can document the model of the IUD and we can verify its safety for the MRI environment. Pregnancy should be self-reported, and a pregnancy test will not be administered. Participants must also weigh less than 440 lbs. * History of holes bored into skull or known fissures in cranial bones * Presence of pacemakers
Where this trial is running
Bloomington, Indiana
- Indiana University — Bloomington, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Joshua Brown, PhD
- Email: jwmbrown@iu.edu
- Phone: 812-855-9282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.