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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Smoking

Treatments: Device: Sham repetitive transcranial magnetic stimulation; Device: Repetitive transcranial magnetic stimulation, MagStim Rapid2

Study type: Interventional

Funder types: Other

Identifiers

NCT02590640

15-1016

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Inhibitory insular rTMS

Active Comparator group

Description:

Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers.

Treatment:

Device: Repetitive transcranial magnetic stimulation, MagStim Rapid2

Sham insular rTMS

Sham Comparator group

Description:

Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.

Treatment:

Device: Sham repetitive transcranial magnetic stimulation