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

NCT ID: NCT05389670

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Continuous Theta-burst stimulation (cTBS)

Intervention Type DEVICE

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.

Sham Theta-burst stimulation

Group Type SHAM_COMPARATOR

Sham Continuous Theta-burst stimulation (cTBS)

Intervention Type DEVICE

Sham cTBS, inhibitory-like patterned form of TMS.

Interventions

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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 Type DEVICE

Sham Continuous Theta-burst stimulation (cTBS)

Sham cTBS, inhibitory-like patterned form of TMS.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Brett Froeliger

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Madhura Athreya, MS

Role: CONTACT

5738822977

Brett Froeliger, PhD

Role: CONTACT

5738824785

Other Identifiers

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2074722

Identifier Type: -

Identifier Source: org_study_id

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