Nicotine Dependence, Nicotine Use Disorder
Conditions
Keywords
TMS, rTMS, Transcranial Magnetic Stimulation, Smoking, Nicotine
Brief summary
The purpose if this study is to determine if five treatments of repetitive transcranial magnetic stimulation (rTMS) can reduce craving for cigarettes in smokers. rTMS uses magnetic pulses to stimulate the brain and is currently approved for the treatment of major depressive disorder.
Interventions
DEVICEActive rTMS with MagVenture MagPro double blind rTMS system
5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
DEVICESham rTMS
Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomized double blind control using a sham rTMS system
Intervention model description
Randomized, double blind, control
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Outpatient Adults aged 18-70 * Cigarette Smokers smoking at least 1 pack (20 cigarettes a day) with current smoking status confirmed by exhaled CO reading of \>10ppm day of visit. * Ability to provide informed consent
Exclusion criteria
* Current treatment with varenicline or bupropion * Currently making a smoking quit attempt (not currently smoking). * Current treatment with an antidepressant, anti-convulsant, anxiolytic, antipsychotic or mood stabilizer. * Current episode of major depression determined by MINI interview. * Current or past history of schizophrenia, schizoaffective disorder, anorexia nervosa, bulimia or bipolar disorder as determined by MINI. * Current daily consumption of alcohol or current alcohol use disorder. * Current substance use disorder except for nicotine or cannabis use disorder. * Currently pregnant or lactating. * Contraindications to rTMS including history of seizure, metal implanted above the neck, pacemaker or any brain lesion. * Unstable medical conditions * Suicidal ideation or history of suicide attempt within the last six months. * Inability or unwillingness of subject or legal guardian/representative to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability Measured by Percent of Participants Completing the rTMS Course | 1 day (single visit) | Percent of participants completing the 5 session rTMS course. Hypothesize \>75% of participants will complete the 5 treatments. |
| Decrease in Cue Induced Nicotine Craving | During the one day visit | Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduce in Self Reported Smoking | 1 week and 2 weeks after rTMS | An exploratory outcome will be the determination if participants receiving active rTMS report decreased levels of smoking 1 week and 2 weeks after rTMS course. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active rTMS 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
Active rTMS with MagVenture MagPro double blind rTMS system: 5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session. | 2 |
| Sham 5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.
Sham rTMS: Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Sham | Total | Active rTMS |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 3 participants | 5 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 1 / 2 | 1 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Decrease in Cue Induced Nicotine Craving
Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving.
Time frame: During the one day visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active rTMS | Decrease in Cue Induced Nicotine Craving | -4.65 Percent change on craving scale |
| Sham | Decrease in Cue Induced Nicotine Craving | -7.6 Percent change on craving scale |
Primary
Tolerability Measured by Percent of Participants Completing the rTMS Course
Percent of participants completing the 5 session rTMS course. Hypothesize \>75% of participants will complete the 5 treatments.
Time frame: 1 day (single visit)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active rTMS | Tolerability Measured by Percent of Participants Completing the rTMS Course | 2 Participants |
| Sham | Tolerability Measured by Percent of Participants Completing the rTMS Course | 3 Participants |
Secondary
Reduce in Self Reported Smoking
An exploratory outcome will be the determination if participants receiving active rTMS report decreased levels of smoking 1 week and 2 weeks after rTMS course.
Time frame: 1 week and 2 weeks after rTMS
Population: Participants did not return follow up phone call