Arvioi nikotiinivuon ja nikotiinimuodon vaikutusta riippuvuuteen liittyviin subjektiivisiin vaikutuksiin
maanantai 24. elokuuta 2026 päivittänyt: American University of Beirut Medical Center
Nikotiinivuo, potentiaalisesti tehokas työkalu elektronisten savukkeiden nikotiinierityksen säätelyyn: Nikotiinivuon merkitys nikotiinin vapautumisnopeuteen ja subjektiivinen vaikutus
Elektroniset nikotiinin annostelujärjestelmät (ENDS) lämmittävät ja höyrystävät nikotiinia sisältävän nesteen muodostaen aerosolin, joka voi kuljettaa nikotiinia vereen ja aivoihin.
ENDS:n käyttö on lisääntynyt nopeasti viimeisen vuosikymmenen aikana, erityisesti nuorten keskuudessa: yli 20 % yhdysvaltalaisista lukiolaisista on nykyisin ENDS:n käyttäjiä, ja tässä väestössä on näyttöä nikotiiniriippuvuudesta.
Liittovaltion lainsäädäntöä on ehdotettu, joka rajoittaisi ENDS:n nestemäisen nikotiinin pitoisuutta, jotta ENDS olisi "merkittävästi vähemmän riippuvuutta aiheuttava ja houkutteleva nuorille".
Nämä ja muut ponnistelut riippuvuuden hillitsemiseksi rajoittamalla nikotiininesteen pitoisuutta eivät kuitenkaan todennäköisesti onnistu, koska ENDS:n nikotiinipäästöt riippuvat useista muuttujista.
Aiottujen kansanterveystavoitteiden saavuttamiseksi riippuvuutta koskevien säännösten on keskityttävä nikotiinin toimittamiseen, ei nikotiinin pitoisuuteen.
Vaikka nikotiinin toimitusta ei voida säädellä suoraan, nopeutta, jolla ENDS vapauttaa nikotiinia, "nikotiinivirtaa", voidaan säädellä ja mikä tärkeintä, ennustaa muutaman laitteen suunnittelun ja toimintamuuttujan perusteella.
Kuitenkaan toistaiseksi ei ole olemassa empiiristä näyttöä, joka osoittaisi virtauksen ja synnytyksen välisen suhteen eikä virtauksen ja nikotiiniriippuvuutta tukevien subjektiivisten vaikutusten välillä.
Tämän aukon kurominen on välttämätöntä tehokkaan kehyksen luomiseksi ENDS:n säätelylle.
Beirutin amerikkalaisessa yliopistossa tutkijat arvioivat nikotiinin virran, muodon ja subjektiivisten vaikutusten välistä suhdetta.
Osallistujat käyttävät ENDS-laitteita, joiden nikotiinivirtaukset ja -muodot vaihtelevat.
Riippuvuustoimenpiteitä, kuten tupakointihalua, himoa ja raittiutta, arvioidaan.
Tulos osoittaa, missä määrin nikotiinin virtaus/muoto vaikuttaa riippuvuuteen, turvotuksen voimakkuuteen ja myrkyllisille altistumiseen liittyviin subjektiivisiin vaikutuksiin.
Yhteenvetona voidaan todeta, että tämä projekti tarjoaa empiiristä näyttöä, jota kansanterveysvirastot tarvitsevat voidakseen käyttää nikotiinivirtausta kattavana ja kätevänä rakenteena ENDS:n nikotiinin toimittamisen säätelemiseksi.
Tutkimuksen yleiskatsaus
Tila
Valmis
Yksityiskohtainen kuvaus
Arvioi nikotiinivirran ja nikotiinimuodon vaikutusta subjektiivisiin vaikutuksiin.
AUB:ssa tutkijat arvioivat subjektiivisia vaikutuksia (esim.
tuotteen mieltymys, nikotiinin himo) ja puffaustopografia 130 osallistujalle, jotka käyvät läpi 5 ENDS-käyttöistuntoa, jotka koostuvat 2 kierroksesta (10 puhallusta + 60 min ad libitum) ja 2 virtausta (16 ja 32 μg/s) x 2 muotoa (protonoitu, vapaapohja) ja 0 nikotiinitila.
Lisäksi tutkijat käyttävät uusinta tekniikkaa ottamaan näytteitä paikan päällä jokaisen puhalluksen aikana syntyvästä aerosolista todellisen nikotiinin virtauksen ja muodon tarkistamiseksi sekä keuhkomyrkkyjen (karbonyylien) altistumisen mittaamiseksi.
Tutkijat olettavat, että nikotiinivirran ja protonoidun nikotiinin lisääntyminen vähentää nikotiinin himoa ja alentaa turvotuksen voimakkuutta ja karbonyylialtistusta.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
142
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Beirut
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Beirut, Beirut, Libanon, 11-0236
- American University of Beirut
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
Sisällyttämiskriteerit:
- On oltava terve ja yli 18-vuotias
- On oltava valmis antamaan tietoinen suostumus, osallistumaan laboratorioon ja pidättäytymään tupakasta/nikotiinista tarpeen mukaan (osallistujia ohjeistetaan pidättymään nikotiinin/tupakan ja/tai ENDS:n käytöstä ≥12 tunnin ajan)
- Kaksi ENDS:ää ja tupakankäyttäjä, joka ilmoittaa käyttävänsä päivittäin ENDS:iä (≥ 3 mg/ml nikotiinia) tai savukkeita (mikä tahansa tiheys) JA joskus (≥ 3 päivää/viikko) ENDS:iä (≥ 3 mg/ml nikotiinia) tai savukkeita (mikä tahansa) taajuus) viimeisen 3 kuukauden aikana tai kauemmin
Poissulkemiskriteerit:
- Krooninen sairaus tai hallitsematon psykiatrinen tila
- Aiempi tai aktiivinen sydän- ja verisuonisairaus, matala/korkea verenpaine, kohtaukset, reseptilääkkeiden säännöllinen käyttö (paitsi vitamiinit/ehkäisy)
- kokaiinin, opioidien, bentsodiatsepiinien tai metamfetamiinien käyttö viimeisen kuukauden aikana
- Henkilöt, jotka ilmoittavat käyttävänsä marihuanaa yli 15/30 päivää
- Naiset suljetaan pois, jos he imettävät tai raskaana
- Osallistujat, jotka aikovat lopettaa tupakan/nikotiinin käytön seuraavien 30 päivän aikana ja jotka viittasivat lopetushoitoon
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Crossover-tehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Placebo Comparator: Plasebo - yhdistelmä viisi - 0 μg/s nikotiinivirta
Tutkijat testaavat nikotiinivirtauksen (0 μg/s) lumelääkkeen subjektiivisia vaikutuksia.
Yhden tunnin havaintojakson jälkeen osallistujat käyttävät Subox Mini C:tä 10 puhalluksen ohjatussa ottelussa (30 sekuntia hengityksen välissä).
Tunti ensimmäisen ottelun jälkeen osallistujia kehotetaan puhaltamaan laitetta 60 minuutin ajan ad libitum.
Subjektiivisia toimenpiteitä (eli nikotiiniriippuvuus, huumeiden vaikutukset, tuotteen mieltymys ja himo) annetaan 5 kertaa/istunto: 5 minuuttia ennen ja 5 minuuttia kohdistetun ottelun alkamisen jälkeen ja 5 minuuttia ennen, puolivälissä ja 5 minuuttia sen jälkeen. ad libitum -ottelu.
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30/70 PG/VG suhde nikotiinipitoisuudella 0mg/ml (plasebo)
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Kokeellinen: 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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Kokeellinen: 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 suhde nikotiinipitoisuudella 10mg/ml protonoitua
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Kokeellinen: 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 suhde nikotiinipitoisuudella 4mg/ml vapaata emästä
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Kokeellinen: 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 suhde nikotiinipitoisuudella 10mg/ml vapaa emäs
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Kokeellinen: 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 -suhde nikotiinikonsentraatiolla 0 mg/ml
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Kokeellinen: 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-neste 7: 30/70 pg/vg-suhde nikotiinipitoisuudella 4mg/ml protonoidun e-nesteen 8: 30/70 pg/vg-suhde nikotiinikonsentraatiolla 8 mg/ml protonoidut
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Kokeellinen: 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-neste 9: 30/70 pg/VG-suhde nikotiinikonsentraatiolla 4mg/ml protonoidun e-nesteen 10: 70/30 pg/vg-suhde nikotiinikonsentraatiolla 4 mg/ml protonoidut
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Subjective Effects - Strong Flavor (Combinations 1-5)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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.
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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)
Aikaikkuna: 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)
Aikaikkuna: 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).
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Puff Duration
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Päätutkija: Soha Talih, PhD, American University of Beirut Medical Center
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Keskiviikko 13. heinäkuuta 2022
Ensisijainen valmistuminen (Todellinen)
Perjantai 11. heinäkuuta 2025
Opintojen valmistuminen (Todellinen)
Perjantai 11. heinäkuuta 2025
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 8. kesäkuuta 2022
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Maanantai 20. kesäkuuta 2022
Ensimmäinen Lähetetty (Todellinen)
Perjantai 24. kesäkuuta 2022
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 18. syyskuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 24. elokuuta 2026
Viimeksi vahvistettu
Lauantai 1. helmikuuta 2025
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- American University Of Beirut
- 1R01DA052565-01A1 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
Osallistujien tiedot eivät ole muiden tutkijoiden saatavilla
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Yhdysvalloissa valmistettu ja sieltä viety tuote
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .