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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 : Recruiting
First Posted : May 22, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Brett Froeliger, Medical University of South Carolina

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel 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
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Intermittent Theta-burst stimulation (iTBS) 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.

Experimental: Continuous Theta-burst stimulation (cTBS) 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.




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



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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.


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


Contacts
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Contact: Madhura Athreya, MS 8437921608 athreya@musc.edu
Contact: Brett Froeliger, PhD 8437926018 froelige@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Brett Froeliger, PhD    843-792-6018    froelige@musc.edu   
Contact: Madhura Athreya, MS    8437921608    athreya@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina

Publications:
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Responsible Party: Brett Froeliger, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03960138     History of Changes
Other Study ID Numbers: 00074836
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
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