Neuronavigated Non-invasive Brain Stimulation for Nicotine Dependence.

University of Missouri-Columbia1 site in 1 country30 target enrollmentOctober 1, 2024

ConditionsNicotine Dependence

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nicotine Dependence
Sponsor: University of Missouri-Columbia
Enrollment: 30
Locations: 1
Primary Endpoint: Acute effects of cTBS on cognitive control
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours.

Registry

clinicaltrials.gov

Start Date

October 1, 2024

End Date

April 30, 2030

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University of Missouri-Columbia

Responsible Party

Principal Investigator

Brett Froeliger

Professor

University of Missouri-Columbia

Eligibility Criteria

Inclusion Criteria

•Nicotine Dependence as measured by: Smoke ≥ 8 cigarettes/day for ≥ 2 yrs, expired carbon monoxide (CO) concentration of ≥ 10 ppm, positive urine cotinine test and FTND score ≥ 3 Or ≥ 15 uses of electronic cigarette/day for ≥ 1 year, positive urine cotinine test, and PS-ECDI score ≥ 3
•English Fluency
•Functional Vision (with corrective lenses as needed)

Exclusion Criteria

•Use of psychotropic and antiepileptic medications in the last month
•Presence of an untreated illness or serious medical condition
•History of major neurological illness
•Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \>15 min., implanted electronic device, metal in the head) or MRI.
•Any use of substances that lower seizure threshold.
•Current or past psychosis
•Electroconvulsive therapy in the past 6 months
•Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea
•BAC greater than 0.
•Positive urine pregnancy test

Outcomes

Primary Outcomes

Acute effects of cTBS on cognitive control

Time Frame: 1 hour after receiving cTBS

between-arm differences in neurocognitive task performance as measured by percent correct on an inhibitory control task and self reported craving on a regulation of craving task.