Theta-burst Repetitive Transcranial Magnetic Stimulation (TBS) of the Right Inferior Frontal Gyrus for Treatment of Nicotine Dependence
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Primary Endpoint
- Change in the number (#) of cigarettes per day.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18-65 yrs. of age
- •Smoke > 5 cigarettes/day for ≥ 2 yrs, and expired carbon monoxide (CO) concentration of ≥ 8 ppm
- •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)
- •Any use of substances that lower seizure threshold
- •Current or past psychosis
- •Electroconvulsive therapy in last 6 months
- •Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea
- •BAC greater than 0.
- •Positive urine pregnancy test
- •Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results
Arms & Interventions
Continuous Theta-burst stimulation (cTBS)
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.
Intervention: Continuous Theta-burst stimulation (cTBS) (Device)
Sham Theta-burst stimulation
Intervention: Sham Continuous Theta-burst stimulation (cTBS) (Device)
Outcomes
Primary Outcomes
Change in the number (#) of cigarettes per day.
Time Frame: 2 months
The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on cigarettes per day (CPD). This is measured by a core daily cigarette diary and will be measured following treatment and after making a quit attempt at: days 14, 21 and 28.
Cigarette craving scores (#) as measured by the questionnaire of smoking urges brief (QSUb).
Time Frame: 2 months
The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on cigarette craving. This will be measured at the end of every visit to the laboratory. The Questionnaire of Smoking Urges brief (QSUb) rages from 0 to 70. Lower scores equal less craving, meaning the lower the score, the better the outcome.
Percent (%) correct on an inhibitory control GoGo/NoGo task.
Time Frame: 2 months
The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on inhibitory control (IC) task performance. This will be measured at : baseline; after completing 12 sessions of cTBS treatment, 3-7 days following making a quit attempt and at days 14, 21 and 28 following quit attempt.
Craving regulation scores (#) on a regulation of craving task.
Time Frame: 2 months
The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on regulation of craving (ROC) task performance. This will be measured at : baseline; after completing 12 sessions of cTBS treatment, 3-7 days following making a quit attempt and at days 14, 21 and 28 following quit attempt.
Secondary Outcomes
- Symptoms scores (#) as measured by the review of symptoms (ROS) questionnaire.(2 months)
Investigators
Brett Froeliger
Professor
University of Missouri-Columbia