Clinical trial NCT03865472: 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
Overall status: RECRUITING
Phase: NA
Conditions: Cigarette Smoker
Current Every Day Smoker
Current Smoker
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Participants will be right-handed
* 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: Has been diagnosed with primary non-small cell LC or with primary non-skin squamous cell HNC (self-reported)
* 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 that prevent an MRI being performed
* 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 that prevent an MRI being performed
  * 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 that prevent an MRI being performed
  * 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

Primary outcomes:
measure: Latency to relapse
timeFrame: Up to 30 days
Secondary outcomes:
measure: Point-prevalence abstinence rates
timeFrame: At 12 and 24 weeks after quit date
measure: Delay discounting rates
timeFrame: At 12 and 24 weeks after quit date
measure: Cognitive-behavioral Therapy Skills Questionnaire
timeFrame: Up to 24 weeks
measure: Side effects
timeFrame: Up to 24 weeks
measure: Forever Free (FF) Booklet content Exposure
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Christine Sheffer
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.