Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes
Phase: NA
Conditions: Tobacco Use Disorder
Sponsor: University of Minnesota

 
Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes 
 
NCT03164668 
 
10/28/2019 
 

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PROTOCOLCOVERPAGE





ProtocolTitle
MentholFlavoredEͲCigaretteUseDuringaSimulatedBanof
MentholCigarettes
Principal
Investigator/Faculty
Advisor
Name:MichaelKotlyar
Department:ExperimentalandClinicalPharmacology
TelephoneNumber:612Ͳ625Ͳ1160
EmailAddress:kotly001@umn.edu
Scientific
Assessment
FundedbyClearWayMN,aMinnesotabasednonͲprofitthat
hasapeerreviewprocessforgrantreview
IND/IDE#(if
applicable)
N/A
IND/IDEHolder
N/A
InvestigationalDrug
Services#(if
applicable)
N/A
Version
Number/Date:
Version3
10/14/2019

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REVISIONHISTORY

Revision#
VersionDate
SummaryofChanges
ConsentChange?
n/a
10Ͳ25Ͳ18
Thissitesupplementisbeing
completedasrequestedbyIRB
duringacontinuingreview
submissionduetochangesin
documentationrequirementsthat
resultinthecurrentlyapproved
protocolnotcontainingenough
informationnecessaryforIRB
review.Thetextinthissite
supplementiscopiedasmuchas
possibledirectlyfromthecurrently
approvedprotocolandthe
originallysubmitted(preͲETHOS)
IRBapplication.
No.
1
3Ͳ29Ͳ19
Thisupdateincludestherequested
increaseinthenumberofsubjects
approvedforenrollmentinthe
studyfrom80to110.
No.
2
10Ͳ14Ͳ19
Updatedsection11.1with
additionalinformationaboutthe
potentialriskofusingeͲcigarettes
/vapingdevices
Yes
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TableofContents
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
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StudyIntervention(s)/InvestigationalAgent(s)
1.1 Description:Thisstudywillenrollapproximately40AfricanAmerican
mentholcigarettesmokerswhowillberandomizedtoacondition
simulatingamentholcigaretteban(i.e.,requiredtoabstainfrommenthol
cigarettesfortwomonths)ortoaconditioninwhichmentholcigarettes
continuetobeavailable(i.e.,norestrictionsonthecigarettestheycan
smoke).Withineachgroup,subjectswillcompleteafourweekperiod
duringwhichtheywillbeassignedmentholflavoredeͲcigarettesandafour
weekperiodduringwhichtheywillbeassignedregularflavoredeͲ
cigarettes.TheVusebrandofeͲcigarettesisbeingtested.Theorderin
whichtheeͲcigarettes(i.e.,mentholvs.regularflavors)willbeassignedwill
berandomized.Duringeachfourweekperiod,subjectswillbeinstructed
tousetheirassignedeͲcigarettesadlibitum.Aftercompletionofthetwo
studyperiods,subjectswillcontinuetobefollowedforanadditional4
weekperiodtodetermineifanychangesintobaccousepatternspersist
aftereͲcigarettesarenolongerprovidedtosubjects.Tobaccouse(e.g.,
cigarettes,eͲcigarettes),othernicotinecontainingproductuse(e.g.,
medicinalnicotine),productliking,motivationtoquitsmoking,biomarkers
oftobaccoandtoxicantexposure,andsupportforbanningmenthol
flavoringintobaccoproductswillbeassessedduringthestudy.This
projectwillprovidepreliminarydataregardinghowthecontinued
availabilityofmentholflavoredeͲcigarettesaffectstobaccousebehaviorin
thecontextofabanonmentholflavoredcigarettesandinthecasethat
mentholflavoredcigarettesarenotbanned.Thesedatawillbeusedto
informthestudydesignandtopoweralargerstudyassessingthe
regulatoryimplicationsoftheavailabilityofmentholflavoredeͲcigarettes.

1.2 Drug/DeviceHandling:Thetobaccoproductbeingstudiedisamarketed
productandisnotrequiredtobedispensedbyaphysicianorlicensed
pharmacy.Itwillbeprovidedtoparticipantsbythestudycoordinator.

1.3 Biosafety:N/A

1.4 StemCells:N/A


LocalProceduresInvolvedandLocalRequirements
2.1 LocalProcedures:Thissitesupplementisbeingcompletedtoprovide
informationnotincludedintheapprovedprotocolduetochangesin
documentationrequirementsthathaveoccurredsincetheprotocolhas
beenapprovedbytheIRB.Thisisasinglesitestudyandtheprocedures
implementedareasapprovedbasedontheinitiallyapprovedIRB
applicationandprotocol.


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2.2 IndividuallyIdentifiableHealthInformation:Allinformationiscollected
directlyfromsubjects(i.e.,medicalrecordswillnotberequested)andthis
isnotatreatmentstudy.Thedatacollectedthereforedonotmeetthe
definitionofPHI.

2.3 Useofradiation:N/A

2.4 UseofCenterforMagneticResonanceResearch:N/A


ProvisionstoMonitortheDatatoEnsuretheSafetyofParticipants
Provisiontomonitorthedataandensurethesafetyofparticipantsareas
describedintheDataandSafetyMonitoringPlansection(page8–9)ofthe
approvedprotocol.AsoutlinedintheoriginalapprovedIRBapplication,thePI
willmonitorstudysafety,dataaccuracyandqualityassurance,trial
management,regulatoryissuesandanyinterimanalyses(ifinterimanalysisare
conducted).



DataandSpecimenBanking
4.1 StorageandAccess:Urinesampleswillbecollectedfromsubjectsas
describedintheapprovedprotocolintheImplementationPlansection
(pages6–8).Thesampleswillbestoredinfreezerslocatedinlabsusedby
facultyintheECPdepartment(currentlythesefreezersarelocatedonthe
5thfloorof717DelawareAve).

4.2 Data:Urinesampleswillbelabeledwithsubjectnumberanddateofvisit.
SampleswillbeassayedforcotinineconcentrationandNNAL
concentrations.Cotinineisametaboliteofnicotineandfrequentlyusedto
confirmabstinenceorquantifynicotineexposure.NNALisbeingmeasured
asanindicatoroftoxicantexposure.Collectedurinemayinthefuturebe
usedtoassayothermeasuresrelatedtosmokinggenerallyorrelatedto
smokingmentholcigarettesspecifically.Examplesofsuchanalysesinclude
assayingnicotineormetabolitesofnicotineotherthancotinine,assaying
mentholconcentrationsorassayingtoxicantsassociatedwithsmoking.

4.3 Release/Sharing:Thecurrentplannedanalyseswillbeperformedbylabs
withintheUniversityofMinnesota.Ifhowever,bythetimethesamples
arecollectedtheselabsarenolongerabletoprovidethisservice,these
samplesmaybesentelsewhereforanalysis.Similarly,ifsamplesareinthe
futureassayedforothermeasures,theymaybesenttoexternal
laboratoriesdependingonthecapabilitiesandcostofsuchanalyses.If
samplesforothermeasuresaresenttoexternallaboratoriesforadditional
assays,theywillbelabeledwithasubjectcodethathasnoidentifiable

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informationonit.Priortosendingsamplestoanoutsidesource,theIRB
willbenotified.



SharingofResultswithParticipants
5.1 SharingofResults:Studyresultswillnotbesharedwithparticipants.


LocalStudyPopulation
6.1 Inclusion/exclusioncriteriaareasdescribedintheResearchDesignand
MethodsSection,Subjectssubsectionoftheapprovedprotocol(onpage
6).ScreeningproceduresareasdescribedintheImplementationPlan
section,ScreeningVisitsubsectionoftheapprovedprotocol(onpage7).


VulnerablePopulations
7.1 VulnerablePopulations:
տChildren
տPregnantwomen/Fetuses/Neonates
տPrisoners
տAdultslackingcapacitytoconsentand/oradultswithdiminished
capacitytoconsent,including,butnotlimitedto,thosewithacute
medicalconditions,psychiatricdisorders,neurologicdisorders,
developmentaldisorders,andbehavioraldisorders
տApproachedforparticipationinresearchduringastressfulsituationsuch
asemergencyroomsetting,childbirth(labor),etc.
տDisadvantagedinthedistributionofsocialgoodsandservicessuchas
income,housing,orhealthcare
տSerioushealthconditionforwhichtherearenosatisfactorystandard
treatments
տFearofnegativeconsequencesfornotparticipatingintheresearch(e.g.
institutionalization,deportation,disclosureofstigmatizingbehavior)
տAnyothercircumstance/dynamicthatcouldincreasevulnerabilityto
coercionorexploitationthatmightinfluenceconsenttoresearchor
decisiontocontinueinresearch
տUndervaluedordisenfranchisedsocialgroup
տMembersofthemilitary
տNonͲEnglishspeakers
տThoseunabletoread(illiterate)
տEmployeesoftheresearcher
տStudentsoftheresearcher
܈Noneoftheabove

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7.2 AdditionalSafeguards:Noneoftheabovegroupsarebeingrecruited;
howeverrecruitmentwillbelimitedtoAfricanAmericansmokersfor
severalreasons.Mentholcigaretteuseisparticularlyprevalentinthe
AfricanAmericancommunitywith80%ofAfricanAmericansreporting
mentholcigarettesastheirusualchoice.Additionally,datasuggestthat
greaterdifficultyincessationofmentholcigarettes(vs.nonͲmenthol
cigarettes)maybelimitedtoAfricanAmericansandthereforeregulations
affectingavailabilityofmentholflavoredproducts,ifenactedtoimprove
cessationratesfrommentholcigarettes,areparticularlyrelevanttothis
population.
Therisksfromparticipatinginthisstudyaresmallinthatsubjectswillbe
provided2monthsofcommerciallyavailableeͲcigarettes.Onlythosewho
smokecigarettesregularlywillbeenrolledandsubjectswillnotbe
instructedtousemoreoftheproductthantheywouldotherwiseusewere
theytoobtaintheproductoutsidethecontextofthestudy.


LocalNumberofParticipants
8.1 LocalNumberofParticipantstobeConsented:Weanticipatedthat
approximately110subjectswillgothroughtheconsentprocessinorderto
recruit40subjectswhocompletethisstudy.


LocalRecruitmentMethods
9.1 RecruitmentMethods:Advertisementsforthestudywillbeplacedin
variousprintandonͲlinesourcesandviaflyers.Interestedparticipantswill
callthephonenumberlistedorafterfollowingaweblinkprovidedin
advertisement,completeanonlinescreeningquestionnaire(advertisement
andquestionnairepreviouslyapprovedbytheIRB).Forindividualscalling
thelistedphonenumber,studystaffwillexplainthestudytopotential
studysubjectsandindividualsthatindicateaninterestinparticipatingin
thestudywillthenbescreenedbytelephonetoseeiftheyarelikelyto
qualifyforthestudy(phonescreeningscriptpreviouslyapprovedbyIRB).
Forindividualscompletingtheonlineform,studypersonnelwillcall
subjectstoletthemknowiftheyareeligibleandtoscheduleascreening
visitforthosewhoare.
Additionallysubjectsthatinpreviousstudiesagreedtobecontacted
regardingotherresearchopportunities(byinitialingtheiragreementtobe
contactedontheconsentform)maybecalled.Thesesubjectswillbe
informedwhytheyarebeingcalledwiththetelephonescreeningprocess

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beingthesameasforsubjectswhocontactedusafterseeingthestudy
advertised.
9.2 IdentificationofPotentialParticipants:Subjectswillberecruitedviathe
useofflyersandadvertisementsinlocalandneighborhoodnewspapersor
oninternetresourcessuchasCraigslistorFacebook.Additionallysubjects
thatinpreviousstudiesagreedtobecontactedregardingotherresearch
opportunities(byinitialingtheiragreementtobecontactedontheconsent
form)maybecalled.
9.3 RecruitmentMaterials:Flyers,advertisingtextandimages(forexamplefor
Facebookadvertising)aspreviouslyapprovedbytheIRBwillbeutilized.
9.4 Payment:Subjectswillbepaid$20forthescreeningvisit,thebaseline
visitandeachofthe5subsequentvisits(i.e.,visitsatweek2,4,6,8,and
12).Subjectswhocompleteallscheduledvisitsandhavecompliedwith
studyrelatedprocedureswillreceivea$60bonus.Subjectcantherefore
receiveupto$200forcompletingthestudyinadditiontopaymentfor
pointsthatwerenotredeemedforeͲcigarettecartridgesduringthefinal
twoweeksofeachevaluationperiod.Subjectswilladditionallybe
providedbustokens(forthosewhotakepublictransportation)orparking
(forthosewhodrive)foreachvisit.Paymentisprovidedviathe
GreenphireClinCard.

 WithdrawalofParticipants
10.1 WithdrawalCircumstances:Subjectsmaybewithdrawnfromthestudyif
theyfailtofollowstudyprocedures(e.g.,showuptoscheduledstudy
visits)oriftherearechangestotheirhealththatarelikelytoaffect
smokingbehavior.Additionally,subjectswillbetoldthatparticipationis
voluntaryandthattheymaydiscontinueparticipationatanytimeforany
reasons.

10.2 WithdrawalProcedures:Wewillattempttocontactsubjectsbytelephone
whodonotshowuptoscheduledvisitstoascertainiftheywishto
continuetoparticipateinthestudy(andifnot,whynot)andtodetermine
smokingstatusatthetimeoftheirwithdrawal.

10.3 TerminationProcedures:Anydatacollectedpriortoasubjectwithdrawing
fromastudywillbeusedinthedataanalysis.

 RiskstoParticipants
11.1 ForeseeableRisks:RisksofbeinginthestudyaredescribedintheDataand
SafetyMonitoringPlanofthepreviouslyapprovedprotocoltemplate(page
8Ͳ9).Belowisthelanguagecopiedfromtheprotocoltemplatewith

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additionalinformationaddedtothethirdandfourthparagraphsregarding
recentreportsofrespiratoryillness.
Risksthatsubjectsareexposedtoasaresultofenrollinginthestudyare
minimal.Althoughsmokingisclearlydetrimentaltohealth,wedonot
anticipatethattheirriskwillincreaseasaresultofbeingenrolledinthe
studysincewewillonlybeenrollingthosewhoalreadysmokeatleast5
cigarettesperday.Furthermore,anyshorttermchangesinsmokingthat
occurasaresultofeitherbeingaskedtoabstainfromsmokingmenthol
cigarettesorfromusingeͲcigarettesforan8weekperiodarenotlikelyto
havelongtermhealtheffects.
TheeͲcigarettesusedforthisstudyarecommerciallyavailableandamong
themostcommonlyusedbrands.Althoughtheseproductsdonot
currentlyundergoregulatoryevaluation,theyareeasilyavailableand
increasinglybeingused.TherisksofusingeͲcigarettesarenotthoughtto
begreaterthanofsmoking(withmanyadvocatingthattheseproductsare
lessharmfulthansmoking).EͲcigarettesdocontainnicotineanditis
possiblethatoverusecanleadtosymptomsofnicotinetoxicitysuchas
nausea,vomiting,dizziness,weaknessandrapidheartbeat.TheeͲcigarette
liquidcontainspropyleneglycolwhichmaybeassociatedwiththroat
irritation.TheeͲcigaretteisabatterypoweredelectronicdeviceso
malfunctionsarepossible.
Therehavebeenrecentreportsofseizuresandbreathingproblems
occurringinpeoplewhouseeͲcigarettes.Thesecasesarebeing
investigatedandatthistimeitisnotknownhowcommontheseproblems
areorwhatiscausingthem.Sincemanyofthecasesofbreathing
problemsoccurredinindividualsusingeͲcigarettesproductswithliquids
thatcontaincannabinoidproductssuchasTHC,itislikelythattheriskis
duetopeopleaddingsubstancestoeͲliquidsthatwerenotintendedbythe
manufacturer.TheeͲcigaretteproductsavailableinthestudyarewidely
availableandwidelyused.Thedevicesandliquidsprovidedtoparticipants
arenotmodifiedinanywayafterpurchase.
Aswithanyproduct,thereisariskthatunanticipatedeffectsfromusing
theeͲcigarettemayoccur.Theriskhoweverofusingtheproductas
directedbythemanufacturerisnohigherthanitwouldbeifsubjectswere
tobuytheeͲcigarettesthemselvesandusethemoutsideofthestudy.

11.2 ReproductionRisks:Smokingcigarettesduringpregnancyisknowntobe
harmfultoreproductivehealth.Wewillthereforeexcludewomenwhoare
pregnantorareplanningtobecomepregnantduringthestudy.Women
whoinformusthattheyhavebecomepregnantduringthestudywillnot
beprovidedanyadditionaltobaccoproducts.

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11.3 RiskstoOthers:Thereareknownrisksassociatedwithsecondhandsmoke,
howeverweareonlyrecruitingthosewhoarealreadysmokingtherefore
therisktoothersshouldnotincreasebyparticipatinginthisstudy.The
secondhandrisksofeͲcigaretteuseareunknownbutarelikelylessthan
therisksofsecondhandsmoke.

 PotentialBenefitstoParticipants
12.1 PotentialBenefits:Asthisisnotatreatmentstudy,thereisnodirect
benefittoindividualparticipants.

 Confidentiality
Measuretakenfortheprotectionoftheconfidentialityofdataaredescribedin
theDataSafetyMonitoringPlansectionoftheapprovedprotocol(page8Ͳ9).

 ProvisionstoProtectthePrivacyInterestsofParticipants
14.1 ProtectingPrivacy:
Subjectswillbetoldthatparticipationisvoluntaryandtheymay
discontinueparticipationatanytimeforanyreason.Furthermore,
subjectswillbeinformedthattheyarefreetonotansweranyquestions
thattheyareuncomfortablewith,howeverbydoingsotheymaybe
excludedfromthestudy(ifeligibilitycannotbeassessed)ordroppedfrom
thestudyifmeasuresofinterestcannotbeascertained.
Toensureconfidentiality,allsubjectswillbeassignedastudyidentification
codetobeusedonalldatacollectionformsexceptthoseforwhichuseof
personalidentifiersismandatory(e.g.,informedconsentform).Forms
thatlinkthenameoftheparticipantandthesubjectidentificationcodewill
bekeptinalockedcabinetorofficeorinanelectronicfilestoredon
passwordprotectedsecurecomputerserversmaintainedbytheUniversity.
Accesstosubjectidentifiableinformationwillbelimitedtothosethat
requirethisinformationsuchasstudyinvestigatorsorotherswhohave
directcontactwithstudysubjects(e.g.,studycoordinator).
Datacollectedviapaperformswillbestoredinalockedfilecabinetor
officeanddatacollectedelectronicallywillbestoredonUniversity
maintainedserversoronRedCap(asecurewebinterface).

14.2 AccesstoParticipants:Alldatawillbecollecteddirectlyfromstudysubjects
(i.e.,nodatawillbeobtainedfrommedicalrecords).

 CompensationforResearchͲRelatedInjury

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15.1 CompensationforResearchͲRelatedInjury:Nocompensationisavailablein
theeventofresearchrelatedinjury.

15.2 ContractLanguage:N/A

 ConsentProcess
16.1 ConsentProcess(whenconsentwillbeobtained):Informedconsentwillbe
obtainedatthescreeningvisit.Subjectswillhavetheopportunitytoread
theconsentdocumentandaskanyquestionsthattheyhave.Amemberof
thestudystaffwillthenaskthesubjectquestionstomakesurethatthey
understandthestudyprocedures.Nostudyprocedureswillbe
administereduntilthesubjecthassignedtheconsentform.

16.2 WaiverorAlterationofConsentProcess(whenconsentwillnotbe
obtained):N/A

16.3 WaiverofWritten/SignedDocumentationofConsent(whenwritten/signed
consentwillnotbeobtained):N/A

16.4 NonͲEnglishSpeakingParticipants:N/A

16.5 ParticipantsWhoAreNotYetAdults(infants,children,teenagersunder18
yearsofage):N/A

16.6 CognitivelyImpairedAdults,oradultswithfluctuatingordiminished
capacitytoconsent:N/A

16.7 AdultsUnabletoConsent:N/A

 Setting
17.1 ResearchSites:Potentialsubjectsarerecruitedviatheuseofflyersand
advertisementsplacedinlocalpublicationsorononͲlineresources(for
example,CraigslistandFacebook).Additionallysubjectsthatinprevious
studiesagreedtobecontactedregardingotherresearchopportunitiesmay
becalled.StudyvisitswilloccurintheClinicalandTranslationalResearch
Institutes(CTSI)facilities.
17.2 InternationalResearch:N/A

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 MultiͲSiteResearch
N/A
 ResourcesAvailable
ThisstudyisbeingfundedbyClearWayMN.Thepersonnelassistingwiththis
study(e.g.,studycoordinators)workwiththeresearchgroupsofthe
investigators.Basedonpreviousstudies,webelievethatthatthereareadequate
smokersinthecommunityinterestedinparticipatinginresearchstudiesinorder
tomeetrecruitmentgoals.



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