Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures

Characterize effects of relighting on smoke toxicant deliveries and subjective smoking measures. This will be a within-subject comparison in a single experimental group of 30 smokers who report engaging in relighting behaviors. We will assess smoking intensity for relit and non-relit (i.e., smoked continuously without relighting) cigarettes in the natural environment and will conduct in-clinic measurements of smoking topography and subjective responses for relit and non-relit cigarettes. Information on relighting patterns and smoking topography collected from each participant will be used to compare machine-measured smoke yields of key harmful constituents when their usual cigarettes are smoked with and without relighting. Hypothesis: Relit cigarettes will produce higher levels of toxicants than non-relit cigarettes.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use; Nicotine Dependence; Cigarette Smoking
• Intervention / Treatment: Other: Cigarettes

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irina Stepanov, PhD; Phone Number: 612-624-4998; Email: stepa011@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • Irina Stepanov, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Smoking at least 10 cigarettes/day for at least 1 year (confirmed by CO > 8 ppm or NicAlert test of 6)
• Engaging in relighting for at least half of their CPD
• No smoking quit attempts in the past month nor intentions to quit in the next month
• Stable medical or psychiatric conditions with systolic blood pressure < 160, diastolic blood pressure < 100 and heart rate < 105 bpm

Exclusion Criteria:

• Participant with current or recent alcohol or drug abuse problems, use of substances of abuse (other than marijuana due to high prevalence of co-use) within the past month
• Currently trying or planning to quit smoking in the next month
• Planning to become pregnant, pregnant or breastfeeding. Pregnancy exclusion will be confirmed through a urine test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continuous Smoking; During the study visits, measures will be taken before and after participants smoke their own usual brand cigarette one continuously. Participants will be randomly assigned to continuous smoking or relight smoking conditions. Participants randomized to the continuous smoking condition will crossover to the relight smoking condition after 60 minutes on their first visit. Visits will be separated by 7-10 days, to ensure there are 2 weekdays and 1 weekend day falling in that period for cigarette butt collection. On the second visit, participants will begin with the second smoking condition they were assigned on their first visit. They will crossover to the remaining condition after 60 minutes. Participants initially assigned to the continuous smoking condition will begin their second visit with the relighting smoking condition and cross over to the continuous smoking condition after the 60 minutes.	Other: Cigarettes; Participants will smoke their own usual brand cigarettes. Cigarette butts will be collected.
Other: Relight Smoking; During the study visits, measures will be taken before and after participants smoke their own usual brand cigarette one continuously. Participants will be randomly assigned to continuous smoking or relight smoking conditions. Participants randomized to the relight smoking condition will crossover to the continuous smoking condition after 60 minutes on their first visit. Visits will be separated by 7-10 days, to ensure there are 2 weekdays and 1 weekend day falling in that period for cigarette butt collection. On the second visit, participants will begin with the second smoking condition they were assigned on their first visit. They will crossover to the remaining condition after 60 minutes. Participants initially assigned to the relighting smoking condition will begin their second visit with the continuous smoking condition and cross over to the relighting smoking condition after the 60 minutes.	Other: Cigarettes; Participants will smoke their own usual brand cigarettes. Cigarette butts will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Nicotine Level	Level of nicotine in cigarette butts collected during study.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Puff Volume	In-clinic measurement of puff volume using topography device.	1 month

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavior; Smoking; Tobacco Smoking; Tobacco Use Disorder; Cigarette Smoking; Tobacco Use; Manufactured Materials; Technology, Industry, and Agriculture; Smoking Devices; Tobacco Products
• Other Study ID Numbers: 2023LS102; R01CA260831 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No