Cigarette Smoking ToxicityMQATNCT01329263

Smoking Topography and Harm Exposure in Menthol Cigarettes

A study testing Menthol to non-menthol in people with Cigarette Smoking Toxicity, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cigarette Smoking Toxicity
What is being tested?: Menthol to non-menthol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteUnited States
Study dates: Sep 2010to Sep 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Self-report smoking daily cigarettes
Self-report smoking menthol flavored cigarettes
Not currently trying to quit or planning to quit in the next 2 months.
Interested in trying a novel cigarette product and willing to smoke a non-menthol cigarette
Self-report smoking only filtered commercially made cigarettes

Who cannot join

Self-report drinking equal to or greater than a certain number of alcohol-containing drinks per week
Self report using any nicotine replacement products or nicotine-containing products other than cigarettes
Self-report substance use disorders in the last 5 years
Self-report current Axis I psychiatric disorders
Self-report past history of Axis I psychiatric disorders other than depression
Self-report myocardial infarction, angina or abnormal rhythms requiring medication

Show all 10Show fewer

Self-report use of select medications and illicit drugs within past six months
Females must not be currently pregnant, planning a pregnancy during the study, or currently breastfeeding/lactating
Provide a baseline carbon monoxide (CO) reading < 10 ppm at initial session
Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

This study will examine how menthol affects smoking when menthol smokers switch to non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples, track cigarette usage and complete smoking topography assessments of smoking behavior.

Read the detailed description

This study will examine how menthol affects smoking behaviors and biomarker level when menthol smokers switch to non-menthol cigarettes. Participants will initially smoke their preferred brand (control) cigarettes, followed by smoking Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples to measure smoke exposures, track cigarette usage to establish changes in daily cigarette consumption and complete smoking topography assessments of smoking behavior, such as puff volume.

Conditions: Cigarette Smoking Toxicity
Being tested: Menthol to non-menthol
Keywords: menthol cigarettes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Menthol to non-mentholOther
Switch from smoking menthol to non-menthol cigarettes.

Study groups in NCT01329263
Study group	Role	What they receive
Nonmenthol	Experimental	Participants switch from menthol to non-menthol cigarettes. Receives: Other: Menthol to non-menthol
Menthol	No intervention	Participants smoke own brand of menthol cigarettes.

What is being measured

The primary outcome is the main question the study is designed to answer.

Smoking Topography- Puff Volume
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.
Measured: over 35 day study period
Smoking Topography- Carbon Monoxide Boost
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.
Measured: Measured before and after each cigarette smoked at study sessions
Nicotine Levels
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.
Measured: 35 days
Subjective Rating of Cigarettes
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.
Measured: Immediately after a cigarette smoked at the study session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Sep 2011

First posted5 Apr 2011 (estimated)
Study startSep 2010
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cigarette Smoking ToxicityStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01329263
Sponsor's protocol ID: 812369
Other IDs: R01CA120594, R01CA130961, P30ES013508, P50CA143187
Acronym: MQAT
Status last verified: Dec 2014
First submitted: 1 Apr 2011
Last updated: 6 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Strasser AA, Ashare RL, Kaufman M, Tang KZ, Mesaros AC, Blair IA. The effect of menthol on cigarette smoking behaviors, biomarkers and subjective responses. Cancer Epidemiol Biomarkers Prev. 2013 Mar;22(3):382-9. doi: 10.1158/1055-9965.EPI-12-1097. Epub 2013 Jan 18.
PubMed 23334588

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Smoking Topography and Harm Exposure in Menthol Cigarettes
ClinicalTrials.gov ID: NCT01329263
Acronym / sponsor ID: MQAT / 812369
Conditions: Cigarette Smoking Toxicity
Keywords: menthol cigarettes
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Cancer Institute (NCI), National Institute of Environmental Health Sciences (NIEHS)
Study start: Sep 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 5 Apr 2011 (estimated)
Results: Posted 15 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nonmenthol	Experimental	Other: Menthol to non-mentholParticipants switch from menthol to non-menthol cigarettes.
Menthol	No intervention	–Participants smoke own brand of menthol cigarettes.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Self-report smoking daily cigarettes
Self-report smoking menthol flavored cigarettes
Not currently trying to quit or planning to quit in the next 2 months.
Interested in trying a novel cigarette product and willing to smoke a non-menthol cigarette
Self-report smoking only filtered commercially made cigarettes

Key exclusion criteria (10 listed)

Self-report drinking equal to or greater than a certain number of alcohol-containing drinks per week
Self report using any nicotine replacement products or nicotine-containing products other than cigarettes
Self-report substance use disorders in the last 5 years
Self-report current Axis I psychiatric disorders
Self-report past history of Axis I psychiatric disorders other than depression

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Menthol to non-mentholSwitch from smoking menthol to non-menthol cigarettes.	Other	Nonmenthol

Primary outcome

Smoking Topography- Puff Volume
Time frame: over 35 day study period
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.
Smoking Topography- Carbon Monoxide Boost
Time frame: 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.
Nicotine Levels
Time frame: 35 days
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.
Subjective Rating of Cigarettes
Time frame: Immediately after a cigarette smoked at the study session
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.

Results and safety

Results posted to the registry on 15 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	15	10
Experimental	45	22

Primary outcome: Smoking Topography- Puff Volume

Time frame: over 35 day study period. Mean (Standard Error). Unit: mL

Measure	Experimental n = 45	Control n = 15
Period 1 Own cigarette	518 (37)	661 (36)
Period 2 Own cigarette or CCrush menthol	650 (48)	620 (41)
Period 3 Own cigarette or CCrush non-menthol	678 (57)	645 (37)

Population analysed: Those completing Study session 2 at Day 5.

Primary outcome: Smoking Topography- Carbon Monoxide Boost

Time frame: Measured before and after each cigarette smoked at study sessions. Mean (Standard Error). Unit: parts per million

Measure	Experimental n = 45	Control n = 15
Period 1 Baseline Own cigarette	5.9 (0.8)	5.3 (0.7)
Period 2 Own cigarette or CCrush menthol	3.7 (0.5)	5.7 (0.6)
Period 3 Own cigarette or CCrush non-menthol	3.9 (0.5)	5.5 (0.8)

Primary outcome: Nicotine Levels

Time frame: 35 days. Mean (Standard Error). Unit: micrograms/mL

Measure	Control n = 15	Experimental n = 45
Period 1 Baseline Own cigarette	2.2 (0.82)	1.7 (0.3)
Period 2 Own cigarette or CCrush non-menthol	3.4 (1.0)	2.7 (0.54)
Period 3 Own cigarette or CCrush non-menthol	2.8 (1.1)	2.49 (.43)

Population analysed: Those completing Day 5, returning sample for assay

Primary outcome: Subjective Rating of Cigarettes

Time frame: Immediately after a cigarette smoked at the study session. Mean (Standard Error). Unit: units on a scale

Measure	Control n = 15	Experimental n = 45
Period 1 Own cigarette	80 (8.1)	61 (5.3)
Period 2 Own cigarette or CCrush menthol	72 (7.3)	52 (5.8)
Period 3 Own cigarette or CCrush non-menthol	71 (6.2)	39 (5.7)

Population analysed: Completed measure

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 15 (0%)	0 of 15 (0%)	Not reported
Experimental	0 of 45 (0%)	0 of 15 (0%)	Not reported

Limitations and caveats (from the sponsor): Attrition rate over 35 day protocol of brand switching cigarette.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23334588Strasser AA, Ashare RL, Kaufman M, Tang KZ, Mesaros AC, Blair IA. The effect of menthol on cigarette smoking behaviors, biomarkers and subjective responses. Cancer Epidemiol Biomarkers Prev. 2013 Mar;22(3):382-9. doi: 10.1158/1055-9965.EPI-12-1097. Epub 2013 Jan 18.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew A Strasser, Ph.D. principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Menthol to non-menthol in people with Cigarette Smoking Toxicity, run by University of Pennsylvania at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Smoking Topography- Puff Volume (time frame: over 35 day study period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01329263, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.