Accelerated rTMS for the Reduction of Nicotine Craving

Medical University of South Carolina5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Nicotine Use Disorder Nicotine Dependence

Interventions

Active rTMS with MagVenture MagPro double blind rTMS systemDEVICE

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.

Sham rTMSDEVICE

Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

MUSC Institute of Psychiatry

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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