Posouzení vlivu toku nikotinu a formy nikotinu na subjektivní účinky související se závislostí
24. srpna 2026 aktualizováno: American University of Beirut Medical Center
Tok nikotinu, potenciálně účinný nástroj pro regulaci dodávky nikotinu z elektronických cigaret: Význam toku nikotinu pro rychlost dodávky nikotinu a subjektivní účinek
Elektronické systémy dodávání nikotinu (ENDS) zahřívají a odpařují kapalinu obsahující nikotin za vzniku aerosolu, který může dodávat nikotin do krve a mozku.
Užívání ENDS se v posledním desetiletí rychle zvýšilo, zejména mezi mládeží: více než 20 % amerických středoškoláků jsou současní uživatelé ENDS a existují důkazy o závislosti na nikotinu u této populace.
Byla navržena federální legislativa, která by omezila koncentraci kapalného nikotinu ENDS, aby se ENDS staly "výrazně méně návykovými a přitažlivými pro mládež."
Tyto a další snahy omezit závislost omezením koncentrace nikotinu v kapalině však pravděpodobně neuspějí, protože emise nikotinu z ENDS závisí na mnoha proměnných.
Aby bylo dosaženo zamýšlených cílů v oblasti veřejného zdraví, musí se předpisy zaměřené na závislost zaměřit na dodávání nikotinu, nikoli na koncentraci nikotinu.
Zatímco dodávku nikotinu nelze regulovat přímo, rychlost, jakou ENDS emituje nikotin, „tok nikotinu“, lze regulovat a, což je důležité, předvídat na základě několika návrhů zařízení a provozních proměnných.
Dosud však neexistují žádné empirické důkazy prokazující vztah mezi fluxem a dodáním, ani mezi fluxem a subjektivními účinky, které podporují závislost na nikotinu.
Překonání této mezery je nezbytné pro poskytnutí účinného rámce pro regulaci ENDS.
Na Americké univerzitě v Bejrútu vyšetřovatelé posoudí vztah mezi tokem nikotinu, formou a subjektivními účinky.
Účastníci budou používat zařízení ENDS s různými toky a formami nikotinu.
Budou posouzena opatření týkající se závislosti, jako je nutkání kouřit, bažení a abstinence.
Výsledek bude indikovat míru, do jaké tok/forma nikotinu ovlivňuje subjektivní účinky související se závislostí, intenzitou nadýmání a expozicí toxickým látkám.
Stručně řečeno, tento projekt poskytne empirické důkazy potřebné pro agentury veřejného zdraví k použití toku nikotinu jako komplexního a pohodlného konstruktu pro regulaci dodávání nikotinu z ENDS.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Detailní popis
Posuďte vliv toku nikotinu a formy nikotinu na subjektivní účinky.
V AUB budou vyšetřovatelé posuzovat subjektivní účinky (např.
oblíbenost produktu, touha po nikotinu) a topografie nafouknutí pro 130 účastníků, kteří absolvují 5 sezení ENDS sestávajících ze 2 záchvatů (10 vdechů + 60 minut ad libitum) se 2 toky (16 a 32 μg/s) x 2 formami (protonovaný, volná báze) a stav 0 nikotinu.
Kromě toho budou vyšetřovatelé používat nejmodernější zařízení k odběru in situ části aerosolu generovaného během každého vdechnutí, aby ověřili skutečný tok a formu nikotinu a změřili expozici plicním toxickým látkám (karbonylům).
Vyšetřovatelé předpokládají, že zvýšení toku nikotinu a protonovaného nikotinu povede k většímu snížení touhy po nikotinu a nižší intenzitě nadýmání a vystavení karbonylu.
Typ studie
Intervenční
Zápis (Aktuální)
142
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Beirut
-
Beirut, Beirut, Libanon, 11-0236
- American University of Beirut
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Popis
Kritéria pro zařazení:
- Musí být zdravý a starší 18 let
- Musí být ochoten poskytnout informovaný souhlas, zúčastnit se laboratoře a podle potřeby se zdržet tabáku/nikotinu (účastníci budou instruováni, aby se zdrželi užívání nikotinu/tabáku a/nebo ENDS po dobu ≥12 hodin)
- Duální uživatel ENDS a uživatel tabáku, který uvádí denní užívání ENDS (≥ 3 mg/ml nikotinu) nebo cigaret (jakákoli frekvence) A jednodenní užívání (≥ 3 dny/týden) ENDS (≥ 3 mg/ml nikotinu) nebo cigaret (jakékoli frekvence) za poslední 3 měsíce nebo déle
Kritéria vyloučení:
- Chronické onemocnění nebo nekontrolovaný psychiatrický stav v anamnéze
- Anamnéza nebo aktivní kardiovaskulární onemocnění, nízký/vysoký krevní tlak, záchvaty, pravidelné užívání léků na předpis (kromě vitamínů/antikoncepce)
- Užívání kokainu, opioidů, benzodiazepinů nebo metamfetaminů za poslední měsíc
- Jedinci, kteří hlásí užívání marihuany > 15/30 dní
- Ženy budou vyloučeny, pokud kojí nebo jsou těhotné
- Účastníci, kteří mají v úmyslu skončit s užíváním tabáku/nikotinu v příštích 30 dnech a odkázali na odvykací léčbu
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: Placebo - kombinace pět - tok nikotinu 0 μg/s
Vyšetřovatelé budou testovat subjektivní účinky toku nikotinu (0 μg/s) placeba.
Po jednohodinovém pozorování budou účastníci používat Subox Mini C v 10-ti šlucích řízených (interval mezi vdechy 30 sekund).
Hodinu po prvním zápase budou účastníci instruováni, aby po dobu 60 minut ad libitum bafli ze zařízení.
Subjektivní měření (tj. závislost na nikotinu, účinky drog, oblíbenost produktů a bažení) budou aplikována 5krát/sezení: 5 minut před a 5 minut po začátku řízeného záchvatu a 5 minut před, v polovině a 5 minut po začátku ad libitum zápas.
|
Poměr PG/VG 30/70 s koncentrací nikotinu 0 mg/ml (placebo)
|
|
Experimentální: 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.
|
30/70 propylene glycol/vegetable glycerin ratio with nicotine concentration 4mg/ml protonated
|
|
Experimentální: 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.
|
Poměr PG/VG 30/70 s koncentrací nikotinu 10 mg/ml protonovaný
|
|
Experimentální: 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.
|
Poměr PG/VG 30/70 s koncentrací nikotinu 4 mg/ml volné báze
|
|
Experimentální: 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.
|
Poměr PG/VG 30/70 s koncentrací nikotinu 10 mg/ml volné báze
|
|
Experimentální: 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.
|
Poměr 30/70 pg/vg s koncentrací nikotinu 0 mg/ml
|
|
Experimentální: 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.
|
Poměr e-kapaliny 7: 30/70 pg/Vg s koncentrací nikotinu 4 mg/ml protonované e-kapaliny 8: 30/70 pg/vg poměr s koncentrací nikotinu 8 mg/ml protonované
|
|
Experimentální: 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.
|
Poměr e-kapaliny 9: 30/70 pg/Vg s koncentrací nikotinu 4 mg/ml protonované e-kapaliny 10: 70/30 pg/vg poměr s koncentrací nikotinu 4 mg/ml protonovaný
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Subjective Effects - Strong Flavor (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Harshness/Irritancy (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Throat Hit (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Overall Like: Flavor (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Overall Like: Harshness (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Overall Like: Throat Hit (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Overall Like: Warmth (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Satisfying (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Pleasant (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Taste Good (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Calm (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Concentrate (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Awake (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Reduce Hunger (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Dizzy (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Feeling Sick (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Want it Right Now (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Smell (Combinations 1-5)
Časové okno: 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.
|
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).
|
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.
|
|
Subjective Effects - Visible Vapor (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Subjective Effects - Importance Vapor (Combinations 1-5)
Časové okno: 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.
|
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).
|
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.
|
|
Subjective Effects - Puffs Similar (Combinations 1-5)
Časové okno: 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.
|
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.
|
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.
|
|
Smoking Urges - Brief Factor 1 (Intention/Desire)
Časové okno: Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
|
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.
|
Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
|
|
Smoking Urges - Brief Factor 2 (Relief of Neg. Affect)
Časové okno: Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
|
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.
|
Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
|
|
Withdrawal Symptoms - Minnesota Nicotine Withdrawal Scale (MNWS; Based on Hughes and Hatsukami, 1986)
Časové okno: 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).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Puff Duration
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Soha Talih, PhD, American University of Beirut Medical Center
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
13. července 2022
Primární dokončení (Aktuální)
11. července 2025
Dokončení studie (Aktuální)
11. července 2025
Termíny zápisu do studia
První předloženo
8. června 2022
První předloženo, které splnilo kritéria kontroly kvality
20. června 2022
První zveřejněno (Aktuální)
24. června 2022
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
24. srpna 2026
Naposledy ověřeno
1. února 2025
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- American University Of Beirut
- 1R01DA052565-01A1 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
Údaje o účastnících nebudou k dispozici ostatním výzkumníkům
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .