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RecruitingNCT06347055Updated Oct 1, 2024

NeuroControl of Nicotine Dependence

An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Nicotine Dependence, sponsored by University of Missouri-Columbia. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nicotine Dependence

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Keywords

  • Tobacco
  • Smoking
  • TMS
  • fMRI
  • Nicotine
  • Cognitive Control
03

In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's planned enrollment of 30 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    cTBS to Ventrolateral Prefrontal Cortex

    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.

    Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

  • Experimental
    cTBS to Dorsomedial Prefrontal Cortex

    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.

    Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

  • Experimental
    cTBS to Vertex

    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.

    Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

  • DeviceRepetitive Transcranial Magnetic Stimulation (rTMS)

    Continuous theta burst rTMS

    Also known as: cTBS

06

What researchers measure

Primary outcomes

  1. Acute effects of cTBS on cognitive control

    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.

    Time frame: 1 hour after receiving cTBS

Secondary outcomes

  1. Exploratory: Acute effects of cTBS on fMRI brain response

    between-arm differences in whole brain fMRI BOLD functional connectivity. Neural network connectivity will be characterized using rZ values.

    Time frame: 1 hour after receiving cTBS

Other outcomes

  1. Safety and Tolerability

    Safety and tolerability of cTBS administered to each cortical location, as measured by self reported side effects on a review of symptoms questionnaire.

    Time frame: 24 hours following receipt of cTBS

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06347055
Lead sponsor
University of Missouri-Columbia
Responsible party
Brett Froeliger (Professor, University of Missouri-Columbia) — Principal investigator
First posted
Apr 4, 2024
Start date
Oct 1, 2024
Primary completion
Mar 25, 2030 (estimated)
Completion
Apr 30, 2030 (estimated)
Last update
Oct 1, 2024

Study contacts

Brett Froeliger, PhD
Contact
froeligerb@health.missouri.edu
573-882-4785

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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