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

NCT02590640 | Completed Results

• 1 other identifier: 15-1016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Inhibitory insular rTMS

ACTIVE COMPARATOR

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

Device: Repetitive transcranial magnetic stimulation, MagStim Rapid2

Sham insular rTMS

SHAM COMPARATOR

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

Device: Sham repetitive transcranial magnetic stimulation

Interventions

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.

Inhibitory insular rTMS

Sham repetitive transcranial magnetic stimulation DEVICE

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

Sham insular rTMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Department of Radiology

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

Data for this study was found to have been compromised. The P.I. responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable and cannot be reported.

Results Point of Contact

• Title: Director, Research Services
• Organization: University of Colorado Denver | Anschutz

clinicalresearchsupportcenter@ucdenver.edu

303-724-1111

Study Officials

• Michael F Regner, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 29, 2015
• Study Start: November 1, 2015
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: July 13, 2022
• Results First Posted: July 13, 2022

Record last verified: 2022-06

Locations

US (1)