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Accelerated rTMS for the Reduction of Nicotine Craving

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ClinicalTrials.gov Identifier: NCT03352609
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
David Friedrich, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Nicotine Use Disorder Nicotine Dependence Device: Active rTMS with MagVenture MagPro double blind rTMS system Device: Sham rTMS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double blind, control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomized double blind control using a sham rTMS system
Primary Purpose: Treatment
Official Title: Accelerated Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex for the Reduction of Craving in Nicotine Dependent Individuals
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Tolerability measured by percent of participants completing the rTMS course [ Time Frame: 1 day (single visit) ]
    Percent of participants completing the 5 session rTMS course. Hypothesize >75% of participants will complete the 5 treatments.

  2. Decrease in cue induced nicotine craving [ Time Frame: During the one day visit ]
    Hypothesize that participants receiving active rTMS will have a greater decrease in cue induced nicotine craving when compared to those in the sham group


Secondary Outcome Measures :
  1. Reduce in self reported smoking [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352609


Contacts
Contact: David Friedrich, MD 843-792-2300 friedric@musc.edu
Contact: Gregory Sahlem, MD 843-792-2300 sahlem@musc.edu

Locations
United States, South Carolina
MUSC Institute of Psychiatry Recruiting
Charleston, South Carolina, United States, 29425
Contact: David Friedrich, MD    843-792-2300    friedric@musc.edu   
Principal Investigator: David Friedrich, MD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: David Friedrich, MD Medical University of South Carolina

Responsible Party: David Friedrich, Resident Physician, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03352609     History of Changes
Other Study ID Numbers: 00070449
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by David Friedrich, Medical University of South Carolina:
TMS
rTMS
Transcranial Magnetic Stimulation
Smoking
Nicotine

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action