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rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers

Primary Purpose

Cigarette Smoker, Current Every Day Smoker, Current Smoker

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaire Administration
Repetitive Transcranial Magnetic Stimulation
Sham Intervention
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cigarette Smoker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 healthy right-handed adults
  • 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 lung cancer patient - Appropriate inclusionary LC diagnoses will include adenocarcinoma in situ, not otherwise specified (NOS); adenocarcinoma, NOS; bronchiolo-alveolar adenocarcinoma, NOS; large cell carcinoma, NOS; adenosquamous carcinoma; neuroendocrine tumor, grade 1; neuroendocrine carcinoma, NOS; atypical carcinoid tumor; non-small cell carcinoma; small cell carcinoma, NOS; combined small cell-large cell carcinoma; squamous cell carcinoma,keratinizing, NOS; Squamous cell carcinoma, nonkeratinizing, NOS; squamous cell carcinoma, sarcomatoid; squamous cell carcinoma, NOS
  • 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 a diagnosis of 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
  • 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
  • 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) 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

Sites / Locations

  • Roswell Park Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm I (rTMS)

Arm II (sham rTMS)

Arm Description

Patients undergo rTMS QD or BID over 16 minutes for 8, 12, or 16 days.

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

Outcomes

Primary Outcome Measures

Latency to relapse
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 4, 2019
Last Updated
May 31, 2023
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03865472
Brief Title
rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers
Official Title
Enhancing Relapse Prevention With rTMS: Dose-Response Parameters for Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2018 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoker, Current Every Day Smoker, Current Smoker

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (rTMS)
Arm Type
Experimental
Arm Description
Patients undergo rTMS QD or BID over 16 minutes for 8, 12, or 16 days.
Arm Title
Arm II (sham rTMS)
Arm Type
Sham Comparator
Arm Description
Patients undergo sham rTMS QD or BID over 16 minutes for 8, 12, or 16 days.
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
rTMS
Intervention Description
Undergo rTMS
Intervention Type
Procedure
Intervention Name(s)
Sham Intervention
Intervention Description
Undergo sham rTMS
Primary Outcome Measure Information:
Title
Latency to relapse
Description
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.
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Point-prevalence abstinence rates
Description
Will use logistic regression models to examine binary 12 and 24-week point prevalence abstinence.
Time Frame
At 12 and 24 weeks after quit date
Title
Delay discounting rates
Description
Will be examined through using repeated measures Generalized Linear models.
Time Frame
At 12 and 24 weeks after quit date
Title
Cognitive-behavioral Therapy Skills Questionnaire
Description
Cognitive behavioral skills will be assessed using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ)
Time Frame
Up to 24 weeks
Title
Side effects
Description
Potential undesirable effects will be measured up to 24 weeks.
Time Frame
Up to 24 weeks
Title
Forever Free (FF) Booklet content Exposure
Description
Will be measured in terms of number of content segments in each booklet.
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Sheffer
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Sheffer
Phone
716-845-1186
Email
Christine.Sheffer@roswellpark.org
First Name & Middle Initial & Last Name & Degree
Christine Sheffer

12. IPD Sharing Statement

Citations:
PubMed Identifier
35874156
Citation
Shevorykin A, Carl E, Mahoney MC, Hanlon CA, Liskiewicz A, Rivard C, Alberico R, Belal A, Bensch L, Vantucci D, Thorner H, Marion M, Bickel WK, Sheffer CE. Transcranial Magnetic Stimulation for Long-Term Smoking Cessation: Preliminary Examination of Delay Discounting as a Therapeutic Target and the Effects of Intensity and Duration. Front Hum Neurosci. 2022 Jul 5;16:920383. doi: 10.3389/fnhum.2022.920383. eCollection 2022.
Results Reference
derived
PubMed Identifier
32357940
Citation
Carl E, Liskiewicz A, Rivard C, Alberico R, Belal A, Mahoney MC, Quisenberry AJ, Bickel WK, Sheffer CE. Dosing parameters for the effects of high-frequency transcranial magnetic stimulation on smoking cessation: study protocol for a randomized factorial sham-controlled clinical trial. BMC Psychol. 2020 May 1;8(1):42. doi: 10.1186/s40359-020-00403-7.
Results Reference
derived

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rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers

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