Trial Outcomes & Findings for Smoking Topography and Harm Exposure in Menthol Cigarettes (NCT NCT01329263)

Results Overview

The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

87 participants

Primary outcome timeframe

over 35 day study period

Results posted on

2015-01-06

Participant Flow

Participants were recruited from the local Philadelphia area via newspaper and internet advertising. Former study participants who had agreed to be contacted for future studies were also contacted. Recruitment began October 2010 and was completed November 2011.

Subjects were required to complete a 5 day baseline assessment of smoking their own brand cigarette. Participants who did this were given study cigarettes. 87 participants signed consents at the first session, 3 did not finish the session. 60 subjects did the 5 day baseline smoking, returned on Day 5, were randomized and included for analysis.

Participant milestones

Participant milestones
Measure	Control Control group: continued to smoke same, own brand cigarette.	Experimental Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
Overall Study STARTED	15	45
Overall Study Completed Period 1 Own Menthol	15	45
Overall Study Completed Period 2 Own or CCrush Menthol	10	30
Overall Study CompletedPer 3 Own or CCrush Non-menthol	10	22
Overall Study COMPLETED	10	22
Overall Study NOT COMPLETED	5	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Control group: continued to smoke same, own brand cigarette.	Experimental Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
Overall Study Lost to Follow-up	4	21
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Smoking Topography and Harm Exposure in Menthol Cigarettes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental n=45 Participants Group switched from menthol cigarette to non-menthol cigarette	Control n=15 Participants Participants smoked their own menthol brand cigarette throughout the study.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	15 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	37.13 years STANDARD_DEVIATION 10.9 • n=5 Participants	37.93 years STANDARD_DEVIATION 12.1 • n=7 Participants	37.4 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	11 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	4 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	15 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: over 35 day study period

Population: Those completing Study session 2 at Day 5.

The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35.

Outcome measures

Outcome measures
Measure	Experimental n=45 Participants Experimental group switched from menthol cigarette to non-menthol cigarette	Control n=15 Participants Control group smoked their own brand cigarette for entire duration of study.
Smoking Topography- Puff Volume Period 1 Own cigarette	518 mL Standard Error 37	661 mL Standard Error 36
Smoking Topography- Puff Volume Period 2 Own cigarette or CCrush menthol	650 mL Standard Error 48	620 mL Standard Error 41
Smoking Topography- Puff Volume Period 3 Own cigarette or CCrush non-menthol	678 mL Standard Error 57	645 mL Standard Error 37

PRIMARY outcome

Timeframe: Measured before and after each cigarette smoked at study sessions

Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases.

Outcome measures

Outcome measures
Measure	Experimental n=45 Participants Experimental group switched from menthol cigarette to non-menthol cigarette	Control n=15 Participants Control group smoked their own brand cigarette for entire duration of study.
Smoking Topography- Carbon Monoxide Boost Period 1 Baseline Own cigarette	5.9 parts per million Standard Error 0.8	5.3 parts per million Standard Error 0.7
Smoking Topography- Carbon Monoxide Boost Period 2 Own cigarette or CCrush menthol	3.7 parts per million Standard Error 0.5	5.7 parts per million Standard Error 0.6
Smoking Topography- Carbon Monoxide Boost Period 3 Own cigarette or CCrush non-menthol	3.9 parts per million Standard Error 0.5	5.5 parts per million Standard Error 0.8

PRIMARY outcome

Timeframe: 35 days

Population: Those completing Day 5, returning sample for assay

Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed.

Outcome measures

Outcome measures
Measure	Experimental n=15 Participants Experimental group switched from menthol cigarette to non-menthol cigarette	Control n=45 Participants Control group smoked their own brand cigarette for entire duration of study.
Nicotine Levels Period 1 Baseline Own cigarette	2.2 micrograms/mL Standard Error 0.82	1.7 micrograms/mL Standard Error 0.3
Nicotine Levels Period 2 Own cigarette or CCrush non-menthol	3.4 micrograms/mL Standard Error 1.0	2.7 micrograms/mL Standard Error 0.54
Nicotine Levels Period 3 Own cigarette or CCrush non-menthol	2.8 micrograms/mL Standard Error 1.1	2.49 micrograms/mL Standard Error .43

PRIMARY outcome

Timeframe: Immediately after a cigarette smoked at the study session

Population: Completed measure

Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste.

Outcome measures

Outcome measures
Measure	Experimental n=15 Participants Experimental group switched from menthol cigarette to non-menthol cigarette	Control n=45 Participants Control group smoked their own brand cigarette for entire duration of study.
Subjective Rating of Cigarettes Period 1 Own cigarette	80 units on a scale Standard Error 8.1	61 units on a scale Standard Error 5.3
Subjective Rating of Cigarettes Period 2 Own cigarette or CCrush menthol	72 units on a scale Standard Error 7.3	52 units on a scale Standard Error 5.8
Subjective Rating of Cigarettes Period 3 Own cigarette or CCrush non-menthol	71 units on a scale Standard Error 6.2	39 units on a scale Standard Error 5.7

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental

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

Dr. Andrew Strasser

University of Pennsylvania

Phone: 2157465788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place