Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures

NCT06295757 | Recruiting DMC

• 2 other identifiers: 2023LS102R01CA260831
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use; Cigarette Smoking; Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• Average Nicotine Level

  Level of nicotine in cigarette butts collected during study.

  1 month

Secondary Outcomes (1)

• Average Puff Volume

  1 month

Study Arms (2)

Continuous Smoking

OTHER

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

Relight Smoking

OTHER

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

Interventions

Cigarettes OTHER

Participants will smoke their own usual brand cigarettes. Cigarette butts will be collected.

Continuous Smoking; Relight Smoking

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Irina Stepanov, PhD

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use; Cigarette Smoking; Tobacco Use Disorder

Interventions

Tobacco Products

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Smoking; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Irina Stepanov, PhD

CONTACT

612-624-4998; stepa011@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: October 12, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)