Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures

Nicotine Dependence Clinical Trial

Official title:

Effects of Relighting on Smoke Toxicant Deliveries and Subjective Smoking Measures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295757
• Other study ID #: 2023LS102
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: May 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: Irina Stepanov, PhD
• Phone: 612-624-4998
• Email: stepa011[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cigarette Smoking
• Nicotine Dependence
• Tobacco Use
• Tobacco Use Disorder

Intervention

Other:
• Cigarettes
Participants will smoke their own usual brand cigarettes. Cigarette butts will be collected.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Nicotine Level	Level of nicotine in cigarette butts collected during study.	1 month
Secondary	Average Puff Volume	In-clinic measurement of puff volume using topography device.	1 month