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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06295757
Other study ID # 2023LS102
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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