Transcranial Magnetic Stimulation and Tobacco Use Disorder

NCT03827265 | Completed DMC FDA Device

• 2 other identifiers: 18-0005091K99DA045749-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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, four three different brain regions. Everyone in the study will be assigned to all four treatment arms 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.

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (4)

• Repetitive Transcranial Magnetic Stimulation (rTMS)

  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

  4 weeks

• Urge to Smoke Questionnaire

  A 10-item self-report questionnaire used to measure spontaneous craving

  4 weeks

• Shiffman-Jarvik Withdrawal Scale

  A 25-item self-report questionnaire used to measure withdrawal

  4 weeks

• Positive and Negative Affect Schedule (PANAS)

  A 20-item questionnaire used to measure mood

  4 weeks

Secondary Outcomes (2)

• Baseline Magnetic Resonance Imaging (MRI)

  4 Weeks

• Post-stimulation Magnetic Resonance Imaging (MRI)

  4 weeks

Study Arms (4)

TMS on SFG

EXPERIMENTAL

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 superior frontal gyrus (SFG). Other Name: rTMS (active stimulation)

Device: repetitive transcranial magnetic stimulation (rTMS)

TMS on PPC

EXPERIMENTAL

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)

TMS on dlPFC

EXPERIMENTAL

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)

TMS on v5

PLACEBO COMPARATOR

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 visual cortex (v5). Other Name: rTMS (sham stimulation)

Device: repetitive transcranial magnetic stimulation (rTMS)

Interventions

repetitive transcranial magnetic stimulation (rTMS) DEVICE

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.

TMS on PPC; TMS on SFG; TMS on dlPFC; TMS on v5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Self-identified as male or female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Semel Institute of Neuroscience

Los Angeles, California, 90024, United States

Location

Related Publications (1)

• Petersen N, Apostol MR, Jordan T, Ngo TDP, Kearley NW, London ED, Leuchter AF. Comparing neuromodulation targets to reduce cigarette craving and withdrawal: a randomized clinical trial. Neuropsychopharmacology. 2025 Aug;50(9):1319-1326. doi: 10.1038/s41386-025-02106-2. Epub 2025 Apr 25.

  PMID: 40281039 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Nicole Petersen, Ph.D

  Faculty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study and only the participant will not be aware of when they will be undergoing the sham stimulation arm.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-in-Residence

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 1, 2019
• Study Start: February 1, 2019
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (1)