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

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Device: Repetitive transcranial magnetic stimulation, MagStim Rapid2; Device: Sham repetitive transcranial magnetic stimulation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Department of Radiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inhibitory insular rTMS; Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers.	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 Comparator: Sham insular rTMS; Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.	Device: Sham repetitive transcranial magnetic stimulation; Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping		1 hour
Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping		1 hour

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Michael F Regner, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): September 6, 2019
• Study Completion (Actual): September 6, 2019

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 28, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 15-1016