Clinical trial NCT02590640: Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers
Official title: Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Cue-induced Cigarette Craving (Post-treatment - Pre-treatment) as Assessed by TCQ
timeFrame: 1 hour
measure: Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping
timeFrame: 1 hour
measure: Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Department of Radiology
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Michael F Regner, MD
role: PRINCIPAL_INVESTIGATOR
References: