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Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking

University of Missouri (MU) logo

University of Missouri (MU)

Status

Completed

Conditions

Tobacco Use Disorder

Treatments

Device: Continuous Theta-burst stimulation (cTBS)
Device: Intermittent Theta-burst stimulation (iTBS)

Study type

Interventional

Funder types

Other

Identifiers

NCT03960138
00074836

Details and patient eligibility

About

The purpose of this research study is to examine the effects of theta-burst Transcranial Magnetic Stimulation on inhibitory control and smoking among adult cigarette smokers.

Enrollment

63 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Be between the ages of 18 and 65.
  2. Be in stable mental and physical health.
  3. Be willing to provide informed consent.
  4. Be able to comply with protocol requirements and likely to complete all study procedures.
  5. Be a current nicotine dependent cigarette smoker (smoke ≥10 cigs/day) with a minimum smoking history of smoking an average of ≥ 10 cigs/day over the past two years.

Exclusion criteria

    1. Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).

    2. Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for > 15 minutes, implanted electronic device, metal in the head, or pregnancy, as indicated by a positive urine pregnancy test at screening).

    3. Any use of substances that lower seizure threshold (such as thyroid medications or cocaine).

    4. History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.

    5. History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.

    6. Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea.

    7. BAC greater than 0.0. 8. Any other condition or concern that in the Investigator's opinion would impact participant safety, compliance with study instructions, or potentially confound the interpretation of the study results.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

63 participants in 2 patient groups

Intermittent Theta-burst stimulation (iTBS)
Experimental group
Description:
Cross-over design - participants will receive both experimental treatments.
Treatment:
Device: Intermittent Theta-burst stimulation (iTBS)
Device: Continuous Theta-burst stimulation (cTBS)
Continuous Theta-burst stimulation (cTBS)
Experimental group
Description:
Cross-over design - participants will receive both experimental treatments.
Treatment:
Device: Intermittent Theta-burst stimulation (iTBS)
Device: Continuous Theta-burst stimulation (cTBS)

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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