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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

Tracking Information
First Submitted Date  ICMJE May 10, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date September 30, 2019
Actual Study Start Date  ICMJE September 26, 2019
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Cigarette Smoking Abstinence [ Time Frame: 3 weeks ]
    Measure the time to first cigarette within a 2 hour period after TMS.
  • 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.
  • Magnitude of change in fMRI brain connectivity [ Time Frame: 3 weeks ]
    Measure the effects of TMS on inhibitory control task performance
  • Cigarette Smoking Puffs [ Time Frame: 3 weeks ]
    Number of puffs are measured of first cigarette smoked after TMS
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03960138 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking
Official Title  ICMJE Examining the Effects of Theta Burst Stimulation on Corticothalamic Mediated Inhibitory Control and Smoking Relapse Vulnerability
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Intermittent Theta-burst stimulation (iTBS)
    Intervention: Device: Intermittent Theta-burst stimulation (iTBS)
  • Experimental: Continuous Theta-burst stimulation (cTBS)
    Intervention: Device: Continuous Theta-burst stimulation (cTBS)
Publications * Froeliger B, McConnell PA, Bell S, Sweitzer M, Kozink RV, Eichberg C, Hallyburton M, Kaiser N, Gray KM, McClernon FJ. Association Between Baseline Corticothalamic-Mediated Inhibitory Control and Smoking Relapse Vulnerability. JAMA Psychiatry. 2017 Apr 1;74(4):379-386. doi: 10.1001/jamapsychiatry.2017.0017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2024
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Madhura Athreya, MS 8437921608 athreya@musc.edu
Contact: Brett Froeliger, PhD 8437926018 froelige@musc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960138
Other Study ID Numbers  ICMJE 00074836
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brett Froeliger, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of South Carolina
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP