Oceń wpływ strumienia nikotyny i postaci nikotyny na subiektywne skutki związane z uzależnieniem
24 sierpnia 2026 zaktualizowane przez: American University of Beirut Medical Center
Strumień nikotyny, potencjalnie potężne narzędzie do regulacji dostarczania nikotyny z elektronicznych papierosów: znaczenie strumienia nikotyny dla szybkości dostarczania nikotyny i subiektywnego efektu
Elektroniczne systemy dostarczania nikotyny (ENDS) podgrzewają i odparowują płyn zawierający nikotynę w celu wytworzenia aerozolu, który może dostarczać nikotynę do krwi i mózgu.
Używanie ENDS gwałtownie wzrosło w ostatniej dekadzie, zwłaszcza wśród młodzieży: ponad 20% uczniów szkół średnich w USA jest obecnie użytkownikami ENDS i istnieją dowody na uzależnienie od nikotyny w tej populacji.
Zaproponowano ustawodawstwo federalne, które ograniczyłoby stężenie nikotyny w płynie ENDS, aby uczynić ENDS „znacznie mniej uzależniającym i atrakcyjnym dla młodzieży”.
Jednak te i inne wysiłki mające na celu ograniczenie uzależnienia poprzez ograniczenie stężenia nikotyny w płynie są mało prawdopodobne, ponieważ emisje nikotyny z ENDS zależą od wielu zmiennych.
Aby osiągnąć zamierzone cele w zakresie zdrowia publicznego, przepisy dotyczące uzależnień muszą koncentrować się na dostarczaniu nikotyny, a nie na stężeniu nikotyny.
Chociaż dostarczanie nikotyny nie może być regulowane bezpośrednio, szybkość, z jaką ENDS emituje nikotynę, „strumień nikotyny”, można regulować i, co ważne, przewidywać na podstawie kilku konstrukcji urządzenia i zmiennych operacyjnych.
Jednak do tej pory nie ma dowodów empirycznych wykazujących związek między przepływem a dostarczaniem, ani między przepływem a subiektywnymi skutkami wspierającymi uzależnienie od nikotyny.
Zamknięcie tej luki ma zasadnicze znaczenie dla zapewnienia skutecznych ram regulujących ENDS.
Na Uniwersytecie Amerykańskim w Bejrucie badacze ocenią związek między przepływem nikotyny, jej formą i subiektywnymi efektami.
Uczestnicy będą używać urządzeń ENDS o różnych strumieniach i formach nikotyny.
Ocenione zostaną środki uzależnienia, takie jak chęć palenia, głód i abstynencja.
Wynik wskaże stopień, w jakim strumień/forma nikotyny wpływa na subiektywne efekty związane z uzależnieniem, intensywnością zaciągania się i ekspozycją na substancje toksyczne.
Podsumowując, projekt ten dostarczy empirycznych dowodów potrzebnych agencjom zdrowia publicznego do wykorzystania strumienia nikotyny jako wszechstronnej i wygodnej konstrukcji do regulowania dostarczania nikotyny z ENDS.
Przegląd badań
Status
Status
Zakończony
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Oceń wpływ strumienia i postaci nikotyny na efekty subiektywne.
W AUB badacze ocenią efekty subiektywne (np.
lubienie produktu, głód nikotynowy) i topografia zaciągania się dla 130 uczestników, którzy przejdą 5 sesji używania ENDS składających się z 2 ataków (10 zaciągnięć + 60 min ad libitum) z 2 strumieniami (16 i 32 μg/s) x 2 formami (protonowana, wolna zasada) i warunek 0 nikotyny.
Ponadto badacze wykorzystają najnowocześniejsze urządzenie do pobrania próbki in situ frakcji aerozolu wytwarzanego podczas każdego zaciągnięcia się, aby zweryfikować rzeczywisty przepływ i formę nikotyny oraz zmierzyć ekspozycję na toksyczne substancje płucne (karbonylki).
Badacze postawili hipotezę, że zwiększenie przepływu nikotyny i protonowanej nikotyny spowoduje większe zmniejszenie głodu nikotynowego oraz mniejszą intensywność zaciągania się i ekspozycję na karbonyl.
Typ studiów
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
Zapisy
142
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Soha Talih, PhD
- Numer telefonu: 3627 +961-1-350000
- E-mail: st38@aub.edu.lb
Lokalizacje studiów
-
-
Beirut
-
Beirut, Beirut, Liban, 11-0236
- American University of Beirut
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Opis
Kryteria przyjęcia:
- Musi być zdrowy i mieć ukończone 18 lat
- Musi być chętny do wyrażenia świadomej zgody, wzięcia udziału w laboratorium i powstrzymania się od tytoniu/nikotyny zgodnie z wymaganiami (uczestnicy zostaną poinstruowani, aby powstrzymać się od nikotyny/tytoniu i/lub używania ENDS przez ≥12h)
- Podwójny ENDS i użytkownik tytoniu, który zgłasza codzienne używanie ENDS (≥ 3 mg/ml nikotyny) lub palenie papierosów (dowolna częstotliwość) ORAZ używanie kiedyś (≥ 3 dni w tygodniu) ENDS (≥ 3 mg/ml nikotyny) lub papierosów (dowolna częstotliwość) przez ostatnie 3 miesiące lub dłużej
Kryteria wyłączenia:
- Historia choroby przewlekłej lub niekontrolowanego stanu psychicznego
- Historia lub czynna choroba układu krążenia, niskie/wysokie ciśnienie krwi, drgawki, regularne stosowanie leków na receptę (z wyjątkiem witamin/antykoncepcji)
- Używanie kokainy, opioidów, benzodiazepin lub metamfetaminy w ciągu ostatniego miesiąca
- Osoby, które zgłaszają używanie marihuany przez >15/30 dni
- Kobiety będą wykluczone, jeśli będą karmić piersią lub będą w ciąży
- Uczestnicy zamierzający rzucić palenie tytoniu/nikotynę w ciągu najbliższych 30 dni i skierowani na leczenie odwykowe
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Podwójnie
Liczba ramion
8
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Komparator placebo: Placebo - Kombinacja Piąta - 0μg/s strumienia nikotyny
Badacze przetestują subiektywne efekty strumienia nikotyny (0 μg/s) placebo.
Po jednogodzinnym okresie obserwacji, uczestnicy użyją Subox Mini C w walce z 10 zaciągnięciami (30-sekundowa przerwa między zaciągnięciami).
Godzinę po pierwszej walce uczestnicy zostaną poinstruowani, aby dmuchać na urządzeniu przez 60 minut ad libitum.
Subiektywne pomiary (tj. uzależnienie od nikotyny, działanie leku, upodobanie do produktu i głód) będą podawane 5 razy na sesję: 5 min przed i 5 min po rozpoczęciu ukierunkowanego ataku oraz 5 min przed, w połowie i 5 min po rozpoczęciu walka ad libitum.
|
Stosunek 30/70 PG/VG przy stężeniu nikotyny 0mg/ml (placebo)
|
|
Eksperymentalny: 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
|
|
Eksperymentalny: 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.
|
Stosunek 30/70 PG/VG przy stężeniu nikotyny protonowanej 10mg/ml
|
|
Eksperymentalny: 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.
|
Stosunek 30/70 PG/VG przy stężeniu nikotyny 4mg/ml wolnej zasady
|
|
Eksperymentalny: 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.
|
Stosunek 30/70 PG/VG przy stężeniu nikotyny 10mg/ml wolnej zasady
|
|
Eksperymentalny: 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.
|
Stosunek 30/70 pg/vg ze stężeniem nikotyny 0 mg/ml
|
|
Eksperymentalny: 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.
|
stosunek E-liquid 7: 30/70 pg/VG ze stężeniem nikotyny 4 mg/ml protonowany E-liquid 8: 30/70 pg/vg ze stężeniem nikotyny 8 mg/ml protonowany
|
|
Eksperymentalny: 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.
|
stosunek e-liquid 9: 30/70 pg/vg ze stężeniem nikotyny 4 mg/ml protonowany e-liquid 10: 70/30 Pg/VG ze stężeniem nikotyny 4 mg/ml protonowany
|
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Subjective Effects - Strong Flavor (Combinations 1-5)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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).
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Puff Duration
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Soha Talih, PhD, American University of Beirut Medical Center
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
13 lipca 2022
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
11 lipca 2025
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
11 lipca 2025
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
8 czerwca 2022
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
20 czerwca 2022
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
24 czerwca 2022
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
18 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 sierpnia 2026
Ostatnia weryfikacja
Ostatnia weryfikacja
1 lutego 2025
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- American University Of Beirut
- 1R01DA052565-01A1 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
Dane uczestników nie będą dostępne dla innych badaczy
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .