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NCT Number: NCT06347055

NeuroControl of Nicotine Dependence

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Neuroscience Center

Columbia, Missouri, 65203, United States

Location status: Recruiting

Location contact

Brett Froeliger, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • English Fluency
  • Functional Vision (with corrective lenses as needed)

Exclusion criteria

  • Use of psychotropic and antiepileptic medications in the last month
  • Presence of an untreated illness or serious medical condition
  • History of major neurological illness
  • 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.
  • Any use of substances that lower seizure threshold.
  • Current or past psychosis
  • Electroconvulsive therapy in the past 6 months
  • Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea
  • BAC greater than 0.0.
  • Positive urine pregnancy test
  • Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results.

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

Continuous theta burst rTMS

Other names: cTBS

Primary outcomes

  1. Acute effects of cTBS on cognitive control

    Time frame: 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 outcomes

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

    Time frame: 1 hour after receiving cTBS

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

Other outcomes

  1. Safety and Tolerability

    Time frame: 24 hours following receipt of cTBS

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

Study contacts

Contact information is provided by the study sponsor or research team.

Brett Froeliger, PhD

CONTACT

[email protected]

573-882-4785

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Neuronavigated Non-invasive Brain Stimulation for Nicotine Dependence.

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Apr 4, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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