Theta-burst Repetitive Transcranial Magnetic Stimulation (TBS) of the Right Inferior Frontal Gyrus for Treatment of Nicotine Dependence

University of Missouri (MU)

Status: Begins enrollment in 8 months

Conditions: Tobacco Use Disorder

Treatments: Device: Sham Continuous Theta-burst stimulation (cTBS); Device: Continuous Theta-burst stimulation (cTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05389670

2074722

Details and patient eligibility

About

The purpose of this research study is to examine the effects of theta-burst Transcranial Magnetic Stimulation on inhibitory control and smoking among adult cigarette smokers. In a double-blind, sham controlled trial, investigators will examine the effects of 12 sessions of cTBS on executive function and smoking behavior.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18-65 yrs. of age
2. Smoke > 5 cigarettes/day for ≥ 2 yrs, and expired carbon monoxide (CO) concentration of ≥ 8 ppm
3. English Fluency
4. Functional Vision (with corrective lenses as needed)

Exclusion criteria

1. Use of psychotropic and antiepileptic medications in the last month
2. Presence of an untreated illness or serious medical condition
3. History of major neurological illness
4. 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)
5. Any use of substances that lower seizure threshold
6. Current or past psychosis
7. Electroconvulsive therapy in last 6 months
8. Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea
9. BAC greater than 0.0.
10. Positive urine pregnancy test
11. Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Continuous Theta-burst stimulation (cTBS)

Experimental group

Description:

Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.

Treatment:

Device: Continuous Theta-burst stimulation (cTBS)

Sham Theta-burst stimulation

Sham Comparator group

Treatment:

Device: Sham Continuous Theta-burst stimulation (cTBS)