Trial Outcomes & Findings for Novel Determinants and Measures of Smokeless Tobacco Use: Study 1 (NCT NCT01067586)

Last Updated: 2022-12-22

Results Overview

Two important harmful constituents in smokeless tobacco products are NNN + NNK, µg/g This measure reports the tobacco-specific nitrosamines (TSNA), N'-nitrosonornicotine (NNN), and 4- (methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) across 7 different smokeless tobacco brands.

Recruitment status

COMPLETED

Target enrollment

359 participants

Primary outcome timeframe

Three "usual" dip sized samples were collected from subjects at baseline

Results posted on

2022-12-22

Participant Flow

Daily users of certain smokeless tobacco products who were 18 years or older were recruited in Minneapolis/St. Paul, MN, Eugene, OR and Morgantown, WV via local advertisements. Subjects were recruited from 2/2010 through 5/2012.

Participant milestones

Participant milestones
Measure	Smokeless Tobacco Users x
Overall Study STARTED	359
Overall Study COMPLETED	359
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Novel Determinants and Measures of Smokeless Tobacco Use: Study 1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smokeless Tobacco Users n=359 Participants x
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	352 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	37.1 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	357 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	331 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	359 participants n=5 Participants
History of smoking >100 cigarettes	350 Participants n=5 Participants
Age of initiation	17.7 years STANDARD_DEVIATION 8.5 • n=5 Participants
Duration of use	13.9 years STANDARD_DEVIATION 11.9 • n=5 Participants
Tins per wek	3.6 tins per week STANDARD_DEVIATION 2.2 • n=5 Participants
Mean dips per day	7.0 Mean dips per day STANDARD_DEVIATION 3.5 • n=5 Participants
Mean duration of dip	69.3 minutes STANDARD_DEVIATION 42.0 • n=5 Participants
Total nicotine equivalents (TNE)	72.8 nmol/mg STANDARD_DEVIATION 70.9 • n=5 Participants
Total NNAL	3.29 pmol/mg creatinine STANDARD_DEVIATION 3.77 • n=5 Participants
Total NNN	0.284 pmol/mg creatinine STANDARD_DEVIATION 3.374 • n=5 Participants

PRIMARY outcome

Timeframe: Three "usual" dip sized samples were collected from subjects at baseline

Population: Products included samples from Copenhagen (Copenhagen Snuff, Copenhagen Long Cut, Copenhagen Long Cut Straight, Copenhagen Long Cut Wintergreen)

Outcome measures

Outcome measures
Measure	Copenhagen n=4 brand variety Products included Copenhagen Snuff, Copenhagen Long Cut, Copenhagen Long Cut Straight, Copenhagen Long Cut Wintergreen	Skoal n=9 brand variety Skoal samples include Skoal Long Cut Straight, Skoal Fine Cut Original, Skoal Long Cut Wintergreen, Skoal Bandits Wintergreen, Skoal Long Cut Mint, Skoal Wintergreen Pouches, Skoal Mint Pouches, Skoal Snus	Kodiak n=2 brand variety Kodiak includes Kodiak Wintergreen, Kodiak Wintergreen Moist Snuff Pouches	Grizzly n=7 brand variety Products include Grizzly Long Cut Straight, Grizzly Strait Pouches, Grizzly Fine Cut Natural, Grizzly Long Cut Mint, Grizzly Mint Pouches, Grizzly Long Cut Wintergreen, Grizzly Wintergreen Pouches	Red Seal n=1 brand variety Product is Red Seal Fine Cut Natural	Marlboro Snus n=4 brand variety Products include Marlboro Snus Original, Marlboro Snus Peppermint, Marlboro Snus Mint, Marlboro Snus Rich	Camel Snus n=4 brand variety Products include Camel Snus Robust, Camel Snus Mellow, Camel Snus Frost, Camel Snus Winterchill
Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands	2.4 ug/g Interval 1.23 to 3.42	2.25 ug/g Interval 1.25 to 3.89	3.19 ug/g Interval 2.97 to 3.4	5.51 ug/g Interval 3.04 to 14.55	2.61 ug/g Interval 2.61 to 2.61	0.74 ug/g Interval 0.64 to 0.78	1.73 ug/g Interval 1.66 to 1.79

Adverse Events

Smokeless Tobacco Brands

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dorothy Hatsukami, PhD

University of Minnesota

Phone: 612-626-2121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place