Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures

Not Applicable

Recruiting

• Conditions: Tobacco Use; Nicotine Dependence; Cigarette Smoking
• Interventions: Other: Cigarettes

• Registration Number: NCT06295757
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-06
• Study Start: 2024-10-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Continuous Smoking	Cigarettes	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.
Relight Smoking	Cigarettes	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.

Primary Outcome Measures

Name	Time	Method
Average Nicotine Level	1 month	Level of nicotine in cigarette butts collected during study.

Secondary Outcome Measures

Name	Time	Method
Average Puff Volume	1 month	In-clinic measurement of puff volume using topography device.

Trial Locations

Locations (1)

Irina Stepanov, PhD; 🇺🇸 Minneapolis, Minnesota, United States