NeuroControl of Nicotine Dependence

University of Missouri (MU)

Status: Enrolling

Conditions: Nicotine Dependence

Treatments: Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06347055

403690

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

30 participants in 3 patient groups

cTBS to Ventrolateral Prefrontal Cortex

Experimental group

Description:

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

cTBS to Dorsomedial Prefrontal Cortex

Experimental group

Description:

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

cTBS to Vertex

Experimental group

Description:

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.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)