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NeuroControl of Nicotine Dependence

Neuronavigated Non-invasive Brain Stimulation for Nicotine Dependence.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06347055
Enrollment
30
Registered
2024-04-04
Start date
2024-10-01
Completion date
2030-04-30
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence

Keywords

Tobacco, Smoking, TMS, fMRI, Nicotine, Cognitive Control

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.

Interventions

DEVICERepetitive Transcranial Magnetic Stimulation (rTMS)

Continuous theta burst rTMS

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Acute effects of cTBS on cognitive control1 hour after receiving cTBSbetween-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

MeasureTime frameDescription
Exploratory: Acute effects of cTBS on fMRI brain response1 hour after receiving cTBSbetween-arm differences in whole brain fMRI BOLD functional connectivity. Neural network connectivity will be characterized using rZ values.

Other

MeasureTime frameDescription
Safety and Tolerability24 hours following receipt of cTBSSafety and tolerability of cTBS administered to each cortical location, as measured by self reported side effects on a review of symptoms questionnaire.

Countries

United States

Contacts

Primary ContactBrett Froeliger, PhD
froeligerb@health.missouri.edu573-882-4785

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026