rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers

March 21, 2024 updated by: Roswell Park Cancer Institute

Enhancing Relapse Prevention With rTMS: Dose-Response Parameters for Smoking Cessation

This trial studies best dose and how well repetitive transcranial magnetic stimulation (rTMS) works in promoting smoking cessation and preventing relapse in current smokers. rTMS is a form of brain stimulation therapy that controls nerve cell activity, increases blood flow in the brain, and improves cognitive function.

Study Overview

Detailed Description

PRIMARY OBJECTIVES:

I. To examine the effects of stimulation duration (stimulation days) and intensity (pulses per day) on outcomes among smokers (sample size [n]=258) motivated to quit.

II. To identify the most promising dosing strategy by balancing effect sizes and undesirable effects.

III. To examine the effects of 16 20Hz rTMS sessions combined with intensive cognitive behavioral treatment and nicotine replacement on smoking cessation, developmental disability (DD rates), cognitive behavioral skill acquisition, and nicotine patch adherence among lung cancer (LC) patients (n=30). (Study 1 and Study 2) IV. To examine the feasibility and potential efficacy of 20Hz rTMS on the left dorsolateral prefrontal cortex (DLPFC) for concurrent smoking abstinence and reductions in alcohol use among smokers who are heavy drinkers (n=20). (Study 1 and Study 2)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo rTMS once daily (QD) or twice daily (BID) over 16 minutes for 8, 12, or 16 days.

ARM II: Patients undergo sham rTMS QD or BID over 16 minutes for 8, 12, or 16 days.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Christine Sheffer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants will be right-handed lung cancer patients
  • Negative urine drug screen at the baseline assessment
  • Ability to read at the 8th grade level
  • Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
  • Participants must smoke between 5 and 25 cigarettes per day with the intent to quit smoking in the next 30 days
  • Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
  • Study 1: Participants will be right-handed lung cancer or head and neck cancer patients
  • Study 1: Age 18+
  • Study 1: Negative urine drug screen at the baseline assessment
  • Study 1: Ability to read at the 8th grade level
  • Study 1: Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
  • Study 1: Participants must smoke at least 4 cigarettes per day and intend to quit smoking in the next 60 days
  • Study 1: Is a patient - with primary non-small and small cell LC or with primary non-skin squamous cell HNC
  • Study 2: Participants will be healthy right-handed adults
  • Study 2: Age 18-65 years old
  • Study 2: Negative urine drug screen at the baseline assessment
  • Study 2: Ability to read at the 8th grade level
  • Study 2: Passes the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TASS)
  • Study 2: Participants must smoke between 5 and 25 cigarettes per day with the intent to quit smoking in the next 30 days
  • Study 2: Meet the criteria for heavy alcohol use: > 7 drinks per week for women, > 15 drinks per week for men OR binge drinking >= 5 days in the past month. Binge drinking is defined as >= 4 drinks for women and >= 5 drinks for men, consumed within 2 hours of each other
  • Study 2: Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

  • Has a personal history of epilepsy
  • Has a history of anticonvulsant medication use
  • Has a personal history of head injury
  • Has a History of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the magnetic resonance imaging (MRI) (e.g., tumor, aneurism, etc.)
  • Has uncontrolled major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus
  • Has any metal implants or neuro-stimulators in the head, neck, or cochlea
  • Has a pacemaker
  • Personal history of migraine headaches
  • Currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion)
  • Currently using medications for tobacco cessation (e.g., nicotine replacement, bupropion, varenicline, etc)
  • Pregnant or planning to become pregnant in the next 24 weeks
  • Current regular use of forms of tobacco other than cigarettes including e-cigarettes
  • Participants who score above 48.3 on the Claustrophobia Questionnaire at the baseline assessment will be excluded because they are likely to be unable to undergo an magnetic resonance imaging (MRI) without distress
  • Individuals who score >15, indicative of moderate-severe Alcohol Use Disorder, on the Alcohol Use Disorders Identification Test (AUDIT).
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study

    • Study 1:Has a personal history of Brain metastases
    • Study 1: Unable to use nicotine patches
    • Study 1: Has a Personal history of epilepsy
    • Study 1: Has a History of anticonvulsant medication use
    • Study 1: Has a Personal history of head injury
    • Study 1: History of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurism, etc.)
    • Study 1: A diagnosis of major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus
    • Study 1: Has any Metal implants or neuro-stimulators in the head, neck, or cochlea
    • Study 1: Has a pacemaker
    • Study 1: Personal history of Migraine headaches
    • Study 1: Currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion)
    • Study 1: Currently using bupropion or varenicline for smoking cessation
    • Study 1: Pregnant or planning to become pregnant in the next 24 weeks
    • Study 1: Current regular use of forms of tobacco other than cigarettes
    • Study 1: Participants who score above 48.3 on the Claustrophobia Questionnaire at the baseline assessment will be excluded because they are likely to be unable to undergo a magnetic resonance imaging (MRI) scan without distress
    • Study 1: Unwilling or unable to follow protocol requirements
    • Study 1: Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study
    • Study 2: Has a personal history of epilepsy
    • Study 2: Has a history of anticonvulsant medication use
    • Study 2: Has a personal history of head injury
    • Study 2: Has a history of aneurysm, stroke, or previous cranial neurosurgery or abnormal findings on the MRI (e.g., tumor, aneurism, etc.)
    • Study 2: Has a diagnosis of major depressive disorder, bipolar disorder or a schizophrenia-spectrum disorder, or tinnitus
    • Study 2: Has any metal implants or neuro-stimulators in the head, neck, or cochlea
    • Study 2: Has a pacemaker
    • Study 2: Personal history of Migraine headaches
    • Study 2: Currently taking medications that lower seizure threshold (e.g., such as tricyclic antidepressants or bupropion)
    • Study 2: Currently using medications for tobacco cessation (e.g., nicotine replacement, bupropion, varenicline, etc.)
    • Study 2: Pregnant or planning to become pregnant in the next 24 weeks
    • Study 2: Current regular use of forms of tobacco other than cigarettes
    • Study 2: Participants who score above 48.3 on the Claustrophobia Questionnaire at the baseline assessment will be excluded because they are likely to be unable to undergo a magnetic resonance imaging (MRI) without distress
    • Study 2: Meet the criteria for severe alcohol use disorder (AUD) (> 6 symptoms) or have ever met Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-V) criteria for alcohol withdrawal. Heavy drinking and AUD are not mutually exclusive.
    • Study 2: Unwilling or unable to follow protocol requirements
    • Study 2: Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (rTMS)
Patients undergo rTMS QD or BID over 16 minutes for 8, 12, or 16 days.
Ancillary studies
Undergo rTMS
Other Names:
  • rTMS
Sham Comparator: Arm II (sham rTMS)
Patients undergo sham rTMS QD or BID over 16 minutes for 8, 12, or 16 days.
Ancillary studies
Undergo sham rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Latency to relapse
Time Frame: Up to 30 days
Latency to relapse will be defined as the number of days from the quit day to relapse. Relapse will be defined as smoking for seven consecutive days. Will use Cox proportional-hazards (CPH) models to examine latency to relapse outcome. Ties in failure times will be handled using methods developed by Efron. Compliance with the CPH assumptions will be tested by coding the factors as time-dependent covariates.
Up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Point-prevalence abstinence rates
Time Frame: At 12 and 24 weeks after quit date
Will use logistic regression models to examine binary 12 and 24-week point prevalence abstinence.
At 12 and 24 weeks after quit date
Delay discounting rates
Time Frame: At 12 and 24 weeks after quit date
Will be examined through using repeated measures Generalized Linear models.
At 12 and 24 weeks after quit date
Cognitive-behavioral Therapy Skills Questionnaire
Time Frame: Up to 24 weeks
Cognitive behavioral skills will be assessed using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ)
Up to 24 weeks
Side effects
Time Frame: Up to 24 weeks
Potential undesirable effects will be measured up to 24 weeks.
Up to 24 weeks
Forever Free (FF) Booklet content Exposure
Time Frame: Up to 24 weeks
Will be measured in terms of number of content segments in each booklet.
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christine Sheffer, Roswell Park Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • i 65718 (Other Identifier: Roswell Park Cancer Institute)
  • NCI-2018-03300 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01CA229415 (U.S. NIH Grant/Contract)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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