NCT05144542.
| Study name | Risk and benefits of electronic cigarettes to older smokers at high risk for lung cancer |
| Methods | RCT Setting: M. D. Anderson Cancer Center, Texas, USA |
| Participants | Estimated enrolment: 330 Inclusion criteria: Meeting National Comprehensive Cancer Network (NCCN) guideline for lung cancer screening; daily or non‐daily smoker; interested in trying ECs to change CC smoking behaviour; willing and able to complete two spirometry sessions Exclusion criteria: Used ECs on more than 2 days in the past 30 days; meet criteria for current major depressive disorder (MDD) or suicidality; report more than once weekly of tobacco products other than CCs during the past 30 days; ever diagnosis of lung cancer, have uncontrolled or unstable medical condition; spirometry forced expiratory volume in 1 second (FEV1) percentage reading < 50; pregnancy/breastfeeding |
| Interventions | EC: type not specified GROUP A: Participants smoke their usual brand of cigarettes for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood, and log daily smoking activity every day for up to 182 days. Participants complete questionnaires over 50 minutes and undergo collection of urine sample at 1, 6, 12, and 26 weeks, and collection of blood samples at 6, 12, and 26 weeks. Participants may also undergo measurement of CO levels at 1, 6, 12, and 26 weeks. GROUP B: Participants vape EC for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood, and log daily smoking activity every day for up to 182 days. Participants complete questionnaires over 50 mins and undergo collection of urine sample at 1, 6, 12, and 26 weeks, and collection of blood samples at 6, 12, and 26 weeks. Participants may also undergo measurement of CO levels at 1, 6, 12, and 26 weeks. |
| Outcomes | 1, 6, 12, and 26 weeks, and collection of blood samples at 6, 12, and 26 weeks Primary outcome measure: Cigarettes per day, diary data of combustible cigarette use over last 24 hours Secondary outcome measures: High‐sensitivity C‐reactive protein (hs‐CRP); white blood cells (WBC); 8‐epi prostaglandin F2 alpha (8‐epi‐PGF2a). All from blood draws at weeks 0, 6, 12, and 26 |
| Starting date | Start date: March 7 2022. Estimated completion date: April 30 2025 |
| Contact information | Jason Robinson, PHD 713‐792‐0919, jdrobinson@mdanderson.org |
| Notes | New to 2022 update |