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

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ClinicalTrials.gov Identifier: NCT03960138
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : December 9, 2021
Sponsor:
Information provided by (Responsible Party):
Brett Froeliger, University of Missouri-Columbia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Device: Intermittent Theta-burst stimulation (iTBS) Device: Continuous Theta-burst stimulation (cTBS) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Examining the Effects of Theta Burst Stimulation on Corticothalamic Mediated Inhibitory Control and Smoking Relapse Vulnerability
Actual Study Start Date : September 26, 2019
Actual Primary Completion Date : April 25, 2021
Actual Study Completion Date : April 25, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intermittent Theta-burst stimulation (iTBS)
Cross-over design - participants will receive both experimental treatments.
 Device: Intermittent Theta-burst stimulation (iTBS)
Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.

Device: Continuous Theta-burst stimulation (cTBS)
Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.
Experimental: Continuous Theta-burst stimulation (cTBS)
Cross-over design - participants will receive both experimental treatments.
 Device: Intermittent Theta-burst stimulation (iTBS)
Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.

Device: Continuous Theta-burst stimulation (cTBS)
Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.


Outcome Measures
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Primary Outcome Measures :
  1. Cigarette Smoking Abstinence [ Time Frame: 3 weeks ]
    Measure the time to first cigarette within a 2 hour period after TMS.

  2. Magnitude of change in fMRI brain response to images [ Time Frame: 3 weeks ]
    Measure the effects of TMS on fMRI BOLD response during an inhibitory control task.

  3. Magnitude of change in fMRI brain connectivity [ Time Frame: 3 weeks ]
    Measure the effects of TMS on inhibitory control task performance

  4. Cigarette Smoking Puffs [ Time Frame: 3 weeks ]
    Number of puffs are measured of first cigarette smoked after TMS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960138


Locations
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United States, Missouri
University of Missouri - Columbia
Columbia, Missouri, United States, 65211
Sponsors and Collaborators
University of Missouri-Columbia
More Information
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Publications:

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Responsible Party: Brett Froeliger, Professor Psychiatry, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03960138    
Other Study ID Numbers: 00074836
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: December 9, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders