Columbia, Missouri 65211

  • Tobacco Use Disorder

Purpose:

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.


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.


Study is Available At:


Original ID:

00074836


NCT ID:

NCT03960138


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Examining the Effects of Theta Burst Stimulation on Corticothalamic Mediated Inhibitory Control and Smoking Relapse Vulnerability


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Missouri-Columbia


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Madhura Athreya, MS
5738822977
athreyam@health.missouri.edu
Backup Contact:Brett Froeliger, PhD
5738824785
froeligerb@health.missouri.edu

Study Dates

Start Date:September 26, 2019
Completion Date:April 30, 2021
Completion Type:Anticipated
Primary Completion Date:April 30, 2021
Primary Completion Type:Anticipated
Verification Date:November 2020
Last Changed Date:November 17, 2020
First Received Date:May 10, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cigarette Smoking Puffs
Time Frame:3 weeks
Safety Issues:False
Description:Number of puffs are measured of first cigarette smoked after TMS
Outcome Type:Primary Outcome
Measure:Magnitude of change in fMRI brain connectivity
Time Frame:3 weeks
Safety Issues:False
Description:Measure the effects of TMS on inhibitory control task performance
Outcome Type:Primary Outcome
Measure:Magnitude of change in fMRI brain response to images
Time Frame:3 weeks
Safety Issues:False
Description:Measure the effects of TMS on fMRI BOLD response during an inhibitory control task.
Outcome Type:Primary Outcome
Measure:Cigarette Smoking Abstinence
Time Frame:3 weeks
Safety Issues:False
Description:Measure the time to first cigarette within a 2 hour period after TMS.

Study Interventions

Intervention Type:Device
Name:Continuous Theta-burst stimulation (cTBS)
Description: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.
Arm Name:Continuous Theta-burst stimulation (cTBS)
Intervention Type:Device
Name:Intermittent Theta-burst stimulation (iTBS)
Description: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.
Arm Name:Continuous Theta-burst stimulation (cTBS)

Study Arms

Study Arm Type:Experimental
Arm Name:Continuous Theta-burst stimulation (cTBS)
Description:Cross-over design - participants will receive both experimental treatments.
Study Arm Type:Experimental
Arm Name:Intermittent Theta-burst stimulation (iTBS)
Description:Cross-over design - participants will receive both experimental treatments.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Missouri-Columbia

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:28249070

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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