Clinical Trials Logo

Clinical Trial Summary

The study will recruit an anticipated 256 adults who currently smoke cigarettes and report a willingness to try switching to alternative, non-combustible products. Participants will be randomized to receive either e-cigarettes or nicotine pouches for a duration of 4 weeks and to 1 of 4 possible regulatory scenarios within products where flavor availability is either menthol and tobacco/unflavored available or tobacco/unflavored only available, and nicotine concentration is either higher (5% e-cig, 6mg pouch) or lower (2.4% e-cig, 3mg pouch). Participants will return for bi-weekly research visits (in person or remote videocall) to complete measures for study aims. Participants will complete a final follow-up at Week 6 to assess maintenance of cigarette reduction and willingness to continue using products once they are no longer provided. The investigators expect to observe which products and constituents lead to greater smoking reduction.


Clinical Trial Description

The study includes 5 visit and assessments over 6 weeks. The intake visit will take approximately 60 minutes and subsequent visits will take approximately 30 minutes. The study is proposed to run for 5 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06077240
Study type Interventional
Source Yale University
Contact Lisa M. Fucito, PhD
Phone 203-200-1470
Email lisa.fucito@yale.edu
Status Recruiting
Phase N/A
Start date June 2024
Completion date January 2029

See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02649556 - A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 N/A
Completed NCT03901066 - Smoking Dependence and Periodontitis
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Completed NCT03305978 - Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan. N/A
Completed NCT00000437 - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) Phase 4
Completed NCT06105424 - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability N/A
Active, not recruiting NCT02752022 - Monitoring the Transition From Smoking to E-cigarettes
Completed NCT02901171 - The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation N/A
Completed NCT02912000 - TEACH: Technology Evaluation to Address Child Health N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT04340830 - The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants N/A
Completed NCT02949648 - Electronic Cigarette Use and Quitting in Youth N/A
Completed NCT02246114 - Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT03448900 - Intervention Study for Smoking Cessation in Spanish College Students N/A
Completed NCT01898507 - Nicotine Metabolism and Low Nicotine Cigarettes N/A
Completed NCT02008292 - Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors N/A