Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers



Status:Recruiting
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 55
Updated:1/19/2019
Start Date:November 2015
End Date:December 2019
Contact:Michael F Regner, MD
Email:michael.regner@ucdenver.edu
Phone:720-848-8576

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The goal of this study is to determine if a specific experimental brain stimulation technique
can be used as a non-invasive way to reduce cigarette cravings in current smokers. This study
plans to learn more about the way an experimental technique called "transcranial magnetic
stimulation" (TMS) affects a specific part of the brain, called the insula. Some research
suggests that this part of the brain plays an important role in craving. The investigators
plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI)
of subjects' brain.

For interested participants, this study requires a single 3 hour appointment, which will
include MRI of the brain as well as TMS.


Inclusion Criteria:

1. Age 18-55

2. Ability to provide informed consent

3. Self-reported current average daily cigarette consumption >10/day for at least 1 year

4. Self-reported motivation to quit smoking

Exclusion Criteria:

1. MRI/TMS exclusions, including

- Claustrophobia

- Intracranial or spinal hardware

- Pacemakers

- MR-incompatible devices (Examples: pacemaker, deep brain stimulator, vagal nerve
stimulator, cochlear implant, insulin pump, implanted medication pump, bone
stimulator, implanted defibrillator)

- History of metal objects or fragments in the eye or skull, including shrapnel or
metal plates

- History of stroke or other brain lesion

- History of attempted suicide or suicidal ideation

- Personal history of headaches, seizures, epilepsy, or status epilepticus

- Family history of epilepsy

- Medications known to lower seizure threshold (e.g., tricyclic antidepressants,
antipsychotics, psychostimulants)

- Increased intracranial pressure, hydrocephalus, or pseudotumor cerebri

- Unstable coronary artery disease

- Current pregnancy or positive urine pregnancy test

2. Neurological illness

3. Prior neurosurgery

4. Schizophrenia

5. Bipolar disorder

6. Current (within the last two months) major depressive disorder

7. Substance dependence or positive urinalysis for opiates, stimulants, cannabis, or
sedative on the day of testing

8. Alcohol dependence or positive breath test for alcohol on the day of testing

9. Use of tobacco products other than cigarettes.
We found this trial at
1
site
Aurora, Colorado 80045
Principal Investigator: Michael F Regner, MD
Phone: 720-848-8576
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Aurora, CO
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