NCT03865472

rTMS in Promoting Smoking Cessation and Preventing Relapse in Current Smokers

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cigarette Smoker
• Current Every Day Smoker
• Current Smoker

Interventions

Type	Name	Description
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Repetitive Transcranial Magnetic Stimulation	Undergo rTMS
PROCEDURE	Sham Intervention	Undergo sham rTMS

Timeline

• Start date: 2018-11-10
• Primary completion: 2025-11-13
• Completion: 2026-11-13
• First posted: 2019-03-07
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States