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Completed

NCT Number: NCT02590640

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Department of Radiology

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-55
  • Ability to provide informed consent
  • Self-reported current average daily cigarette consumption >10/day for at least 1 year
  • Self-reported motivation to quit smoking

Exclusion criteria

  • 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
  • Neurological illness
  • Prior neurosurgery
  • Schizophrenia
  • Bipolar disorder
  • Current (within the last two months) major depressive disorder
  • Substance dependence or positive urinalysis for opiates, stimulants, cannabis, or sedative on the day of testing
  • Alcohol dependence or positive breath test for alcohol on the day of testing
  • Use of tobacco products other than cigarettes.

Treatment and study plan

Repetitive transcranial magnetic stimulation, MagStim Rapid2

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 repetitive transcranial magnetic stimulation

Device

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

Primary outcomes

  1. Changes in Cue-induced Cigarette Craving (Post-treatment - Pre-treatment) as Assessed by TCQ

    Time frame: 1 hour

    Cue-induced cigarette craving as assessed by Tobacco Craving Questionnaire (TCQ)

  2. Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping

    Time frame: 1 hour

  3. Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2015
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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