NeuroControl of Nicotine Dependence

Not Applicable

Recruiting

• Conditions: Nicotine Dependence
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

• Registration Number: NCT06347055
• Lead Sponsor: University of Missouri-Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-04
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Study Start: 2024-10-01
• Last Update Posted: 2024-10-01
• Primary Completion: 2030-03-25
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. 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
2. English Fluency
3. 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) or MRI.
5. Any use of substances that lower seizure threshold.
6. Current or past psychosis
7. Electroconvulsive therapy in the past 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
cTBS to Vertex	Repetitive Transcranial Magnetic Stimulation (rTMS)	Continuous theta-burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. cTBS will be applied to the vertex.
cTBS to Ventrolateral Prefrontal Cortex	Repetitive Transcranial Magnetic Stimulation (rTMS)	Continuous theta-burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. cTBS will be applied to the ventrolateral prefrontal cortex.
cTBS to Dorsomedial Prefrontal Cortex	Repetitive Transcranial Magnetic Stimulation (rTMS)	Continuous theta-burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. cTBS will be applied to the dorsomedial prefrontal cortex.

Primary Outcome Measures

Name	Time	Method
Acute effects of cTBS on cognitive control	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.

Secondary Outcome Measures

Name	Time	Method
Exploratory: Acute effects of cTBS on fMRI brain response	1 hour after receiving cTBS	between-arm differences in whole brain fMRI BOLD functional connectivity. Neural network connectivity will be characterized using rZ values.

Trial Locations

Locations (1)

Health Neuroscience Center; 🇺🇸 Columbia, Missouri, United States