Vurder indflydelsen af nikotinflux og nikotinform på subjektive effekter relateret til afhængighed
24. august 2026 opdateret af: American University of Beirut Medical Center
Nikotinflux, et potentielt kraftfuldt værktøj til regulering af nikotinlevering fra elektroniske cigaretter: Nikotinfluxens betydning for hastigheden af nikotinlevering og subjektiv effekt
Elektroniske nikotinleveringssystemer (ENDS) opvarmer og fordamper en nikotinholdig væske for at producere en aerosol, der kan levere nikotin til blodet og hjernen.
Brugen af ENDS er steget hurtigt i det sidste årti, især blandt unge: over 20 % af amerikanske gymnasieelever er nuværende ENDS-brugere, og der er tegn på nikotinafhængighed i denne befolkning.
Føderal lovgivning er blevet foreslået, der ville begrænse ENDS flydende nikotinkoncentration for at gøre ENDS "betydeligt mindre vanedannende og tiltrækkende for unge."
Det er dog usandsynligt, at disse og andre bestræbelser på at bremse afhængighed ved at begrænse nikotinvæskekoncentrationen vil lykkes, fordi nikotinemissioner fra ENDS afhænger af flere variabler.
For at nå de tilsigtede folkesundhedsmål skal regler, der er rettet mod afhængighed, fokusere på nikotinlevering, ikke nikotinkoncentration.
Mens nikotintilførsel ikke kan reguleres direkte, kan den hastighed, hvormed en ENDS udsender nikotin, "nikotinfluxen", reguleres og, hvad der er vigtigt, forudsige baseret på nogle få enhedsdesign og driftsvariable.
Til dato er der dog ingen empiriske beviser, der viser forholdet mellem flux og levering, og heller ikke mellem flux og de subjektive effekter, der understøtter nikotinafhængighed.
At lukke dette hul er afgørende for at skabe en effektiv ramme for regulering af ENDS.
På det amerikanske universitet i Beirut vil efterforskerne vurdere forholdet mellem nikotinflux, form og subjektive effekter.
Deltagerne vil bruge ENDS-enheder med varierende nikotinstrømme og -former.
Afhængighedstiltag, såsom rygetrang, trang og afholdenhed, vil blive vurderet.
Resultatet vil indikere i hvilken grad nikotin flux/form påvirker subjektive effekter relateret til afhængighed, pusteintensitet og eksponering for giftstoffer.
Sammenfattende vil dette projekt give den empiriske evidens, der er nødvendig for, at offentlige sundhedsmyndigheder kan bruge nikotinflux som en omfattende og bekvem konstruktion til at regulere nikotinlevering fra ENDS.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Vurder indflydelsen af nikotinflux og nikotinform på subjektive effekter.
På AUB vil efterforskerne vurdere subjektive effekter (f.eks.
produktelsker, nikotin-trang) og pustende topografi for 130 deltagere, som vil gennemgå 5 ENDS-brugssessioner bestående af 2 anfald (10 pust + 60 min ad libitum) med 2 fluxer (16 og 32μg/s) x 2 former (protoneret, fribase) og en 0 nikotintilstand.
Derudover vil efterforskerne bruge en state-of-the-art anordning til at prøve in situ en brøkdel af aerosolen, der dannes under hvert pust, for at verificere den faktiske nikotinflux og form og måle eksponeringen for pulmonale toksiske stoffer (carbonyler).
Efterforskerne antager, at øget nikotinflux og protoneret nikotin vil resultere i større reduktion af nikotintrang og lavere pusteintensitet og carbonyleksponering.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
142
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Beirut
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Beirut, Beirut, Libanon, 11-0236
- American University of Beirut
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Skal være rask og over 18 år
- Skal være villig til at give informeret samtykke, deltage i laboratoriet og afholde sig fra tobak/nikotin efter behov (deltagere vil blive instrueret i at afstå fra nikotin/tobak og/eller SLUTTER brug i ≥12 timer)
- En dual ENDS- og tobaksbruger, der rapporterer daglig brug af ENDS (≥ 3 mg/ml nikotin) eller cigaretter (en hvilken som helst frekvens) OG en dag (≥ 3 dage/uge) af ENDS (≥ 3 mg/ml nikotin) eller cigaretter (enhver frekvens) hyppighed) inden for de seneste 3 måneder eller længere
Ekskluderingskriterier:
- Anamnese med kronisk sygdom eller en ukontrolleret psykiatrisk tilstand
- Anamnese med eller aktiv kardiovaskulær sygdom, lavt/højt blodtryk, kramper, regelmæssig brug af receptpligtig medicin (undtagen vitaminer/prævention)
- Brug af kokain, opioider, benzodiazepiner eller metamfetamin i den seneste måned
- Personer, der rapporterer, at de bruger marihuana >15/30 dage
- Kvinder vil blive udelukket, hvis de ammer eller er gravide
- Deltagere, der har til hensigt at holde op med at bruge tobak/nikotin inden for de næste 30 dage og henviste til ophørsbehandling
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: Placebo - Kombination Fem - 0μg/s nikotin flux
Efterforskerne vil teste de subjektive virkninger af nikotin flux (0μg/s) placebo.
Efter en en-times observationsperiode vil deltagerne bruge Subox Mini C i en 10-pust-styret (30 sek inter-puff interval) kamp.
En time efter den første kamp vil deltagerne blive instrueret i at puste på enheden i 60 minutter ad libitum.
Subjektive mål (dvs. nikotinafhængighed, lægemiddeleffekter, produktelsker og trang) vil blive administreret 5 gange/session: 5 minutter før og 5 minutter efter start af den rettede kamp og 5 minutter før, halvvejs ind i og 5 minutter efter start af ad libitum kampen.
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30/70 PG/VG-forhold med nikotinkoncentration 0mg/ml (placebo)
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Eksperimentel: Combination One - 15μg/s protonated nicotine flux
The investigators will test the subjective effects of nicotine flux (15μg/s) coupled with one ratio of nicotine form (100% protonated).
Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout.
One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum.
Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.
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30/70 propylene glycol/vegetable glycerin ratio with nicotine concentration 4mg/ml protonated
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Eksperimentel: Combination Two - 35μg/s protonated nicotine flux
The investigators will test the subjective effects of nicotine flux (35μg/s) coupled with one ratio of nicotine form (100% protonated).
Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout.
One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum.
Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.
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30/70 PG/VG-forhold med nikotinkoncentration 10mg/ml protoneret
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Eksperimentel: Combination Three - 15μg/s free base nicotine flux
The investigators will test the subjective effects of nicotine flux (15μg/s) coupled with one ratio of nicotine form (100% free base).
Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout.
One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum.
Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.
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30/70 PG/VG-forhold med nikotinkoncentration 4mg/ml fri base
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Eksperimentel: Combination Four - 35μg/s free base nicotine flux
The investigators will test the subjective effects of nicotine flux (35μg/s) coupled with one ratio of nicotine form (100% free base).
Following a one-hour observation period, participants will use Subox Mini C in a 10-puff directed (30sec inter-puff interval) bout.
One hour after the first bout, participants will be instructed to puff on the device for 60-min ad libitum.
Subjective measures (i.e., nicotine dependence, drug effects, product liking, and craving) will be administered 5 times/session: 5 min before and 5 min after onset of the directed bout and 5 min before, halfway into and 5 min after onset of the ad libitum bout.
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30/70 PG/VG-forhold med nikotinkoncentration 10mg/ml freebase
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Eksperimentel: Combination six - 0μg/s flux; high power/low power
The investigators will test the subjective effects (perceived mouthful, perceived draw effort, and throat hit) at two power levels (20W and 40 W) with no nicotine in the liquid.
Participants will alternate 10 directed puffs (30sec inter-puff interval) between two Subox Mini C devices differing only by the two power levels.
Subjective measures will be administered following puff pairs 1&2, 5&6, and 9&10.
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30/70 PG/VG -forhold med nikotinkoncentration 0 mg/ml
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Eksperimentel: Combination seven - 35μg/s flux; high power/low power
The investigators will test the subjective effects (perceived mouthful, perceived draw effort, and throat hit) at two power levels (20W and 40 W) and a constant nicotine flux of 35 ug/s.
Participants will alternate 10 directed puffs (30sec inter-puff interval) between two Subox Mini C devices (20 W; 8mg/ml and 40 W;4 mg/ml).
Subjective measures will be administered following puff pairs 1&2, 5&6, and 9&10.
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E-væske 7: 30/70 PG/VG-forhold med nikotinkoncentration 4 mg/ml Protoneret E-væske 8: 30/70 PG/VG-forhold med nikotinkoncentration 8 mg/ml protoneret
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Eksperimentel: Combination eight - 15μg/s flux; high PG(propylene glycol)/VG(vegetable glycerin) / low PG/VG
The investigators will test the subjective effects (perceived mouthful, perceived draw effort, and throat hit) at two propylene glycol/vegetable glycerin ratios (30/70 and 70/30).
Participants will alternate 10 directed puffs (30sec inter-puff interval) between two Subox Mini C devices differing only by the two PG/VG ratios.
Subjective measures will be administered following puff pairs 1&2, 5&6, and 9&10.
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E-væske 9: 30/70 PG/VG-forhold med nikotinkoncentration 4 mg/ml protoneret E-væske 10: 70/30 PG/VG-forhold med nikotinkoncentration 4 mg/ml protoneret
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Subjective Effects - Strong Flavor (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Strong flavor will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating a stronger perceived flavor.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Harshness/Irritancy (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Harshness/irritancy will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating harsher/more irritating effects.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Throat Hit (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Throat hit will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating a stronger throat hit.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Overall Like: Flavor (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Overall like: flavor will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the flavor was liked more.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Overall Like: Harshness (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Overall like: harshness will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the harshness was liked more.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Overall Like: Throat Hit (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Overall like: throat hit will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the throat hit was liked more.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Overall Like: Warmth (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Overall like: warmth will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the warmth was liked more.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Satisfying (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Satisfying will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater satisfaction.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Pleasant (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Pleasant will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater pleasantness.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Taste Good (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Taste good will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating better taste.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Calm (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Calm will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling calmer.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Concentrate (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Concentrate will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating better ability to concentrate.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Awake (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Awake will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling more awake/alert.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Reduce Hunger (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Reduce hunger will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater reduction in hunger.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Dizzy (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Dizzy will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater dizziness.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Feeling Sick (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Feeling sick will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling more sick.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Want it Right Now (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Want it right now will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating a stronger immediate desire for the product.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Smell (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Smell will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating a stronger perceived smell.
This item is drawn from the Electronic Cigarette Specific Effects Questionnaire, a modified/expanded version of the modified Cigarette Evaluation Questionnaire (mCEQ; Cappelleri et al., 2007) developed for ENDS.
Participants rate the item on a 0-10 scale immediately following each bout.
Item wording: 'Did the e-cig produce a smell?' (0 = not at all, 10 = extremely).
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Visible Vapor (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Visible vapor will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating more visible vapor.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Importance Vapor (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Importance vapor will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating vapor visibility mattered more to the participant.
This item is drawn from the Electronic Cigarette Specific Effects Questionnaire, a modified/expanded version of the modified Cigarette Evaluation Questionnaire (mCEQ; Cappelleri et al., 2007) developed for ENDS.
Participants rate the item on a 0-10 scale immediately following each bout.
Item wording: 'Is the vapor/cloud of the e-cig important to you?' (0 = not at all, 10 = extremely).
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Subjective Effects - Puffs Similar (Combinations 1-5)
Tidsramme: Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Puffs similar will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating the puffs were perceived as more similar to the participant's usual product.
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Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
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Smoking Urges - Brief Factor 1 (Intention/Desire)
Tidsramme: Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Brief Factor 1 (Intention/Desire) will be assessed by the Questionnaire of Smoking Urges-Brief (QSU-Brief; Tiffany & Drobes, 1991; Toll et al., 2006).
Factor 1 is the sum of 6 items, each rated on a 0-10 scale (0=strongly disagree, 10=strongly agree), yielding a total score range of 0-60, with higher scores indicating stronger urges.
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Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Smoking Urges - Brief Factor 2 (Relief of Neg. Affect)
Tidsramme: Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Brief Factor 2 (Relief of Neg.
Affect) will be assessed by the Questionnaire of Smoking Urges-Brief (QSU-Brief; Tiffany & Drobes, 1991; Toll et al., 2006).
Factor 2 is the sum of 4 items, each rated on a 0-10 scale (0=strongly disagree, 10=strongly agree), yielding a total score range of 0-40, with higher scores indicating stronger urges.
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Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Withdrawal Symptoms - Minnesota Nicotine Withdrawal Scale (MNWS; Based on Hughes and Hatsukami, 1986)
Tidsramme: Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
|
The Minnesota Nicotine Withdrawal Scale (MNWS; based on Hughes and Hatsukami, 1986 questionnaire) was measured using composite mean of MNWS items (irritability, anxiety, difficulty concentrating, restlessness, hunger/appetite, Impatient, depression, desire for sweets and craving) on a 0-10 scale (Not at all - Extremely), with higher scores indicating greater withdrawal severity.
|
Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Puff Duration
Tidsramme: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Puff duration combination 1,2,3,4 & 5
|
Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Number of Puffs
Tidsramme: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Measured topography Total Number of Puffs (puffs).
|
Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Puffing Time
Tidsramme: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Measured topography Average Puffing time (sec).
|
Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Inter Puff Interval
Tidsramme: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Measured topography Average Inter Puff Interval (sec).
|
Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Flow Rate
Tidsramme: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Measured topography Average Flow rate (Liters per minute: LPM).
|
Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Mouth-level PM
Tidsramme: Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Mouth-level PM (Particulate matter) dose estimated using the REALTIME real-time in-situ sampling device, which collects 5% of the aerosol at the mouthpiece during each puff; values are reported as the total session dose (5% fraction × 20), in mg.
|
Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Mouth-level Nicotine
Tidsramme: Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
Mouth-level nicotine dose estimated using the REALTIME real-time in-situ sampling device, which collects 5% of the aerosol at the mouthpiece during each puff; values are reported as the total session dose (5% fraction × 20), in mg.
|
Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
|
|
Puff Duration - Combination 6,7 & 8
Tidsramme: Will be measured during the approximately 5-minute, 10-puff use bout
|
Measured topography Average Puff Duration (sec) - using Subox mini C. Puffs were administered in alternating order using block randomization; for Combination Six, odd puffs were delivered at 20W and even puffs at 40W; for Combination Seven, odd puffs were delivered at 20W/8mg/mL and even puffs at 40W/4mg/mL; for Combination Eight, odd puffs were delivered at 30/70 PG/VG and even puffs at 70/30 PG/VG.
|
Will be measured during the approximately 5-minute, 10-puff use bout
|
|
Sensory Feedback - Perceived Mouthful - Using Kangertech Subox Mini C (Sub-ohm Device)
Tidsramme: Will be measured during the approximately 5-minute, 10-puff use bout
|
The perceived mouthful will be assessed using the following question: "How would you rate the amount of smoke filling your mouth during the puff you just smoked?".
A subjective visual analog scale will be used (1-5, barely any smoke- a lot of smoke) with higher scores indicating higher mouthful.
Puffs were administered in alternating order using block randomization; for Combination Six, odd puffs were delivered at 20W and even puffs at 40W; for Combination Seven, odd puffs were delivered at 20W/8mg/mL and even puffs at 40W/4mg/mL; for Combination Eight, odd puffs were delivered at 30/70 PG/VG and even puffs at 70/30 PG/VG.
|
Will be measured during the approximately 5-minute, 10-puff use bout
|
|
Sensory Feedback - Perceived Draw Effort - Using Kangertech Subox Mini C (Sub-ohm Device)
Tidsramme: Will be measured during the approximately 5-minute, 10-puff use bout
|
The perceived draw effort will be assessed using the following question: " How would you rate the effort needed to draw the puff you just smoked?".
A subjective visual analog scale will be used (1-5, easy- hard) with higher scores indicating harder draw effort.
Puffs were administered in alternating order using block randomization; for Combination Six, odd puffs were delivered at 20W and even puffs at 40W; for Combination Seven, odd puffs were delivered at 20W/8mg/mL and even puffs at 40W/4mg/mL; for Combination Eight, odd puffs were delivered at 30/70 PG/VG and even puffs at 70/30 PG/VG.
|
Will be measured during the approximately 5-minute, 10-puff use bout
|
|
Sensory Feedback - Throat Hit - Using Kangertech Subox Mini C (Sub-ohm Device)
Tidsramme: Will be measured during the approximately 5-minute, 10-puff use bout
|
The perceived Throat hit will be assessed using the following question: "How would you describe the throat hit of the device you just used" (0-100 General Labeled Magnitude Scale; anchors: "barely detectable" to "strongest imaginable").
Puffs were administered in alternating order using block randomization; for Combination Six, odd puffs were delivered at 20W and even puffs at 40W; for Combination Seven, odd puffs were delivered at 20W/8mg/mL and even puffs at 40W/4mg/mL; for Combination Eight, odd puffs were delivered at 30/70 PG/VG and even puffs at 70/30 PG/VG.
|
Will be measured during the approximately 5-minute, 10-puff use bout
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Soha Talih, PhD, American University of Beirut Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. juli 2022
Primær færdiggørelse (Faktiske)
11. juli 2025
Studieafslutning (Faktiske)
11. juli 2025
Datoer for studieregistrering
Først indsendt
8. juni 2022
Først indsendt, der opfyldte QC-kriterier
20. juni 2022
Først opslået (Faktiske)
24. juni 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. august 2026
Sidst verificeret
1. februar 2025
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- American University Of Beirut
- 1R01DA052565-01A1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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