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

NCT ID: NCT02590640

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-09-06

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.

Conditions

Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Inhibitory insular rTMS

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

Group Type: ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation, MagStim Rapid2

Intervention Type: DEVICE

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 insular rTMS

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

Group Type: SHAM_COMPARATOR

Sham repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Sham repetitive transcranial magnetic stimulation

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael F Regner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Department of Radiology

Aurora, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-1016

Identifier Type: -

Identifier Source: org_study_id