trial testing Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK in Smoking in 16 participants. Completed in 14 April 2025.
Timeline
1 September 2020
Primary endpoint 15 October 2021
14 April 2025
Quick facts
Lead sponsor
Masonic Cancer Center, University of Minnesota
Status
Completed
Study type
OBSERVATIONAL
Enrollment
16
Start date
1 September 2020
Primary completion
15 October 2021
Estimated completion
14 April 2025
Sites
1 location across United States
Drugs / interventions tested
Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK
21 and older, any sex, with Smoking. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Ratio of D4-hydroxy Acid to D4- NNAL (an Estimate if NNK Alpha Hydroxylation)Primary· 7 days
Difference in means of the ratio of D4-hydroxy acid to D4- NNAL (an estimate if NNK alpha hydroxylation) for the two groups (null versus average CYP2A6 activity)
Group
Value
95% CI
Smokers With Very Low or no CYP2A6 Activity
0.133
± 0.096
Smokers With High CYP2A6 Activity
0.175
± 0.066
Sponsor's own description
The risk of lung cancer varies by individual and by ethnic/racial group. In this study the investigators will explore how individual differences in the metabolism of a tobacco-specific lung carcinogen may contribute to the variable risk of lung cancer between ethnic/racial groups.
In this 10 day clinical trial, Japanese Americans will smoke a cigarette containing deuterium-labeled 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), a tobacco-specific lung carcinogen. The study cigarette will be smoked for 7 days.
This will allow for NNK metabolic profiling and determining the effect of CYP2A6 genotype on the level of NNK α-hydroxylation in Japanese Americans smokers using \[pyridine- D4\]-NNK containing cigarettes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT07488741 — Comparison of the Effects of Different Chest Techniques on University Students With Smoking Addiction
· NA
· recruiting
NCT07443631 — Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
· NA
· recruiting
NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products
· NA
· recruiting
NCT06966258 — Inspire HER: Inspiring the Heart and Emotions for Radical Health
· NA
· recruiting
NCT06713603 — Technology Assisted Motivational Interviewing
· NA
· recruiting
Other Masonic Cancer Center, University of Minnesota trials
Trials by the same sponsor.
NCT06772090 — Probiotic Supplementation During Cytotoxic Chemotherapy for Solid Tumor Malignancies
· NA
· not yet recruiting
NCT06584929 — Rural Smoking Cessation
· NA
· not yet recruiting
NCT07153016 — LEgal Guidance and AdvocaCY for CAREgivers (LEGACY CARE): A Pilot Clinical Trial for Caregivers of Persons With Colorect
· NA
· recruiting
NCT06792825 — HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL
· Phase 2
· recruiting
NCT07070726 — UNTOLD Ovarian Cancer Unmet Needs Survey
· recruiting
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Masonic Cancer Center, University of Minnesota
Last refreshed: 1 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04228952.