Accelerated rTMS for the Reduction of Nicotine Craving

Accelerated Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex for the Reduction of Craving in Nicotine Dependent Individuals

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 Overview

• Status: Terminated
• Conditions: Nicotine Dependence; Nicotine Use Disorder
• Intervention / Treatment: Device: Active rTMS with MagVenture MagPro double blind rTMS system; Device: Sham rTMS

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC Institute of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Sham Comparator: Sham; 5 session of sham rTMS delivered with Magpro (MagVenture) double blind rTMS system to mimic active intervention.	Device: Sham rTMS; Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During the one day visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week and 2 weeks after rTMS

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: David Friedrich, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): December 12, 2018

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Smoking; Transcranial Magnetic Stimulation; rTMS; Nicotine; TMS
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 00070449

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes