rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers

NCT03865472 | Active Not Recruiting

• 3 other identifiers: i 65718NCI-2018-03300R01CA229415
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoker; Current Every Day Smoker; Current Smoker

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 30 days

Secondary Outcomes (5)

• Point-prevalence abstinence rates

  At 12 and 24 weeks after quit date

• Delay discounting rates

  At 12 and 24 weeks after quit date

• Cognitive-behavioral Therapy Skills Questionnaire

  Up to 24 weeks

• Side effects

  Up to 24 weeks

• Forever Free (FF) Booklet content Exposure

  Up to 24 weeks

Study Arms (2)

Arm I (rTMS)

EXPERIMENTAL

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

Other: Questionnaire Administration; Procedure: Repetitive Transcranial Magnetic Stimulation

Arm II (sham rTMS)

SHAM COMPARATOR

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

Other: Questionnaire Administration; Procedure: Sham Intervention

Interventions

Questionnaire Administration OTHER

Ancillary studies

Arm I (rTMS); Arm II (sham rTMS)

Repetitive Transcranial Magnetic Stimulation PROCEDURE

Undergo rTMS

Also known as: rTMS

Arm I (rTMS)

Sham Intervention PROCEDURE

Undergo sham rTMS

Arm II (sham rTMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 and have been diagnosed with primary non-small and small cell lung cancer or with non-skin squamous cell HNC (self-reported)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Related Publications (3)

• Shevorykin A, Carl E, Liskiewicz A, Hanlon CA, Bickel WK, Mahoney MC, Vantucci D, Bensch L, Thorner H, Marion M, Sheffer CE. Perceived research burden of a novel therapeutic intervention: A study of transcranial magnetic stimulation for smoking cessation. Front Rehabil Sci. 2023 Mar 3;4:1054456. doi: 10.3389/fresc.2023.1054456. eCollection 2023.

  PMID: 36937103 DERIVED

• 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.

  PMID: 35874156 DERIVED

• 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.

  PMID: 32357940 DERIVED

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Christine Sheffer

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 7, 2019
• Study Start: November 10, 2018
• Primary Completion: November 13, 2025
• Study Completion (Estimated): November 13, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)