Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Magnetic Stimulation and Tobacco Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03827265
Recruitment Status : Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Nicole Petersen, University of California, Los Angeles

Brief Summary:

The purpose of this study is to determine if brain stimulation using repetitive transcranial magnetic stimulation (rTMS) directed at different parts of the brain can decrease feelings of cigarette craving and symptoms of cigarette withdrawal, and also if men and women have different responses to rTMS.

Participants will visit the University of California, Los Angeles (UCLA) five times: First, for in-person screening, then for four rTMS sessions, stimulating three different brain regions and also a sham control stimulation. The sham procedure is similar to a placebo, and will use a lower-intensity stimulation than the active stimulations. Everyone in the study will be assigned to all four treatment arms (one sham stimulation, and active stimulation of three different brain regions), and they will take place in a random order.Before and after each rTMS session, a brief MRI will be performed, and participants will be asked to fill out questionnaires that describe how they are feeling.


Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Device: repetitive transcranial magnetic stimulation (rTMS) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Masking Description: This is a single-blind study and only the participant will not be aware of when they will be undergoing the sham stimulation arm.
Primary Purpose: Other
Official Title: Transcranial Magnetic Stimulation and Tobacco Use Disorder: A Network-Level Approach With Attention to Sex as a Biological Variable
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Experimental: TMS on SMA

Device: repetitive transcranial magnetic stimulation (real)

Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target the Supplementary Motor Area (SMA).

Other Name: rTMS (active stimulation)

Device: repetitive transcranial magnetic stimulation (rTMS)
A rTMS system is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. The device is intended to be used to treat patients meeting clinical criteria for MDD as defined in the Diagnostic and Statistical Manual of Mental Illnesses, Fourth Edition (DSM-IV). This guidance is issued in conjunction with a Federal Register notice announcing the classification of rTMS systems for the treatment of MDD.

Experimental: TMS on PPC

Device: repetitive transcranial magnetic stimulation (rTMS)

Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target the posterior parietal cortex (PPC).

Other Name: rTMS (active stimulation)

Device: repetitive transcranial magnetic stimulation (rTMS)
A rTMS system is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. The device is intended to be used to treat patients meeting clinical criteria for MDD as defined in the Diagnostic and Statistical Manual of Mental Illnesses, Fourth Edition (DSM-IV). This guidance is issued in conjunction with a Federal Register notice announcing the classification of rTMS systems for the treatment of MDD.

Experimental: TMS on dlPFC

Device: repetitive transcranial magnetic stimulation (rTMS)

Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain.This arm will target the dorsolateral prefrontal cortex (dlPFC).

Other Name: rTMS (active stimulation)

Device: repetitive transcranial magnetic stimulation (rTMS)
A rTMS system is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. The device is intended to be used to treat patients meeting clinical criteria for MDD as defined in the Diagnostic and Statistical Manual of Mental Illnesses, Fourth Edition (DSM-IV). This guidance is issued in conjunction with a Federal Register notice announcing the classification of rTMS systems for the treatment of MDD.

Sham Comparator: TMS (Sham Stimulation)

Device: repetitive transcranial magnetic stimulation (rTMS)

Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will be a sham stimulation.

Other Name: rTMS (sham stimulation)

Device: repetitive transcranial magnetic stimulation (rTMS)
A rTMS system is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. The device is intended to be used to treat patients meeting clinical criteria for MDD as defined in the Diagnostic and Statistical Manual of Mental Illnesses, Fourth Edition (DSM-IV). This guidance is issued in conjunction with a Federal Register notice announcing the classification of rTMS systems for the treatment of MDD.




Primary Outcome Measures :
  1. rTMS [ Time Frame: 4 weeks ]
    Data from the brain regions that will be targeted with repetitive transcranial magnetic stimulation (rTMS) will be used to assess changes in craving, withdrawal, and affect

  2. Urge to Smoke Questionnaire [ Time Frame: 4 weeks ]
    A 10-item self-report questionnaire used to measure spontaneous craving

  3. Shiffman-Jarvik Withdrawal Scale [ Time Frame: 4 weeks ]
    A 25-item self-report questionnaire used to measure withdrawal

  4. Positive and Negative Affect Schedule (PANAS) [ Time Frame: 4 weeks ]
    A 20-item questionnaire used to measure mood


Secondary Outcome Measures :
  1. Baseline MRI [ Time Frame: 4 Weeks ]
    Resting-state fMRI data will be collected before the TMS session

  2. Post-stimulation MRI [ Time Frame: 4 weeks ]
    Resting-state fMRI data will be collected after the TMS session



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identified as male or female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-45 years old
  • Self-identified as male or female
  • English fluency;
  • Generally good health without cardiovascular, hepatic, renal, or autoimmune diseases; diabetes; or cancer
  • Must have smoked for 1 year; smoke 10 cigarettes per day
  • Meeting DSM 5 criteria for Tobacco Use Disorder

Exclusion Criteria:

  • Seeking treatment for nicotine dependence now or within 3 months before study entry
  • A medical condition that may compromise safety
  • A neurological disorder that would compromise compliance and/or informed consent
  • A major psychiatric disorder
  • Current drug use disorders other than Tobacco Use Disorder as defined by DSM 5
  • Recent use of drugs of abuse as shown by urine test at the screening or testing sessions
  • Smoke marijuana more than once a week
  • Use of tobacco in forms other than cigarettes more than 10 days in last month
  • Preference for menthol
  • Pregnancy or nursing
  • Seizure disorder
  • Metal implants
  • Any other circumstance that the investigators determine would compromise safety

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): NCT03827265


Contacts
Layout table for location contacts
Contact: Nicole Petersen, Ph.D 310-206-7438 npetersen@ucla.edu
Contact: Andrea Donis, B.A 310-206-3005 adonis@mednet.ucla.edu

Sponsors and Collaborators
University of California, Los Angeles
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Investigators
Layout table for investigator information
Principal Investigator: Nicole Petersen, Ph.D Postdoctoral Fellow

Layout table for additonal information
Responsible Party: Nicole Petersen, Postdoctoral Fellow, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03827265     History of Changes
Other Study ID Numbers: 18-000509
1K99DA045749-01 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Tobacco Use Disorder
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders