Smoking
Conditions
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.
Interventions
DEVICERepetitive 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.
DEVICESham repetitive transcranial magnetic stimulation
Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Cue-induced Cigarette Craving (Post-treatment - Pre-treatment) as Assessed by TCQ | 1 hour | Cue-induced cigarette craving as assessed by Tobacco Craving Questionnaire (TCQ) |
| 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 | — |
Countries
United States
Participant flow
Pre-assignment details
Arms cannot be reported separately. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Inhibitory insular rTMS group: Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers. Repetitive transcranial magnetic stimulation, MagStim Rapid2:
And
Sham insular rTMS group: Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Changes in Craving Cue-induced fMRI Activity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping
Time frame: 1 hour
Population: Data cannot be reported. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable.
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)
Time frame: 1 hour
Population: Data cannot be reported. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable.
Primary
Changes in fMRI Connectivity (Post-treatment - Pre-treatment) at Whole Brain Level Using Statistical Parametric Mapping
Time frame: 1 hour
Population: Data cannot be reported. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable.