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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590640
• Other study ID #: 15-1016
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: September 6, 2019

Study information

• Verified date: June 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 6, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

Device:
• Repetitive transcranial magnetic stimulation, MagStim Rapid2
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.
• Sham repetitive transcranial magnetic stimulation
Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.

Locations

Country	Name	City	State
United States	University of Colorado Department of Radiology	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Cue-induced Cigarette Craving (Post-treatment - Pre-treatment) as Assessed by TCQ	Cue-induced cigarette craving as assessed by Tobacco Craving Questionnaire (TCQ)	1 hour
Primary	Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping		1 hour
Primary	Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping		1 hour