Vurdering af effekten af nikotinreduktion på ENDS-brugeres afhængighed og eksponeringer
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Brugen af elektroniske nikotinleveringssystemer (ENDS eller e-cigaretter) har nået epidemiske niveauer blandt unge mennesker i USA (USA). ENDS udsender giftige stoffer, herunder nikotin, der irreversibelt påvirker den udviklende hjerne og fører til afhængighed og øget risiko for cigaretrygning. Beviser tyder på, at unge, der bruger ENDS, sandsynligvis vil accelerere brugen og blive nikotinafhængige. Nogle af de mest populære ENDS blandt unge (f.eks. JUUL med 5 % nikotinvæske) leverer i én patron en nikotindosis svarende til en hel pakke cigaretter, og mange brugere er ikke klar over denne betydelige eksponering og den relaterede risiko for afhængighed. På den anden side er nikotinreduktion (NR) blevet betragtet af US Food and Drug Administration (FDA) som en vigtig strategi til at begrænse afhængigheden og brugen af tobaksprodukter.
Nu hvor FDA regulerer ENDS under "deeming rule", kan en sådan strategi overvejes for disse nye tobaksprodukter. Efterforskerne mangler dog stadig dokumentation for de forventede virkninger af en række NR-niveauer på ENDS-brugere på forskellige stadier af brugsforløbet. Ved at bruge kliniske og analytiske laboratoriemetoder planlægger efterforskerne at sammenligne effekten af delvis (3 %) eller total (nikotinfri, 0 %) NR blandt 5 % nikotin ENDS-brugere på brugernes afhængighed, tilfredshed, kliniske (f.eks. BP, oximetri, lungefunktioner, symptomer), pusteadfærd og eksponering for giftstoffer. Efterforskerne vil rekruttere nuværende ENDS-brugere (n=120; 21-35 år) til en 2X2 inden for emne crossover laboratorieundersøgelse. Nikotinforholdene (5 %, 3 %) eller (0 %, 5 %) x 2 gange (før efter) er faktorer inden for emnet.
Derfor er undersøgelsen opdelt i 2 dele, hvor den første del vil være 2x2, der sammenligner NJOY 5% og 3% for at teste virkningerne af delvis nikotinreduktion, og den anden del vil være at bruge NIDA Standardized Research Electronic Cigarette (SREC) til Clinical Research 5% og 0% (placebo), for at teste effekten af den samlede reduktion ved brug af de samme bælg og juice fra samme producent.
Efterforskerne antager, at NR vil være forbundet med mindre tilfredshed, abstinensundertrykkelse og intention om at bruge, og at en sådan effekt vil være mere udtalt i alt sammenlignet med delvis NR og blandt høj sammenlignet med lav-afhængige brugere. De foreslåede undersøgelser sigter mod at besvare 3 regulatoriske hovedspørgsmål: 1) er NR en lovende regulatorisk mulighed for at reducere ENDS afhængighed og brug; 2) hvad er effekten af delvis vs. total NR på kompenserende pust og eksponering for nikotin og luftvejsgifte, og 3) hvad er effekten af NR på ENDS-brugere på forskellige stadier af deres brug. Kombineret vil disse undersøgelser give direkte og standardiseret evidens for potentialet af NR-regler for at begrænse afhængigheden og brugen af ENDS og hjælpe med at forudsige eventuelle potentielle bivirkninger af NR på ENDS-brugeres eksponering for skadelige giftstoffer.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Florida
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Miami, Florida, Forenede Stater, 33199
- Florida International University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Generelt raske personer (bestemt ved fysisk undersøgelse).
- Alder 21-35 år.
- Er villig til at give informeret samtykke.
- Er villig til at deltage i laboratoriet som krævet af undersøgelsesprotokollen.
- Brugere af elektroniske cigaret (defineret som at bruge elektronisk cigaret enten dagligt eller lejlighedsvis inden for de seneste 30 dage)
- Har undladt at bruge elektroniske cigaretter i 12 timer før hver session
Ekskluderingskriterier:
- Rapporter jævnligt rygning af cigaretter (> 5 cigaretter/måned det seneste år).
- Rapportér regelmæssig brug af andre tobaks-/nikotinprodukter (f.eks. vandpibe, piber, cigarer) i det seneste år.
- Kvinder, der ammer eller tester positiv for graviditet (ved urinanalyse ved screening).
- Personer med selvrapporteret historie med kronisk sygdom eller aktuelle psykiatriske tilstande.
- Personer med historie eller aktiv hjerte-kar-sygdom, lavt eller højt blodtryk, anfald og regelmæssig brug af receptpligtig medicin (bortset fra vitaminer eller prævention).
- Personer, der rapporterer aktuel THC (marihuana) rygning/dampning.
- Personer, der rapporterer brugen af ikke-kommerciel (dvs. gade) e-cigaretvæske eller produkter
- Personer, der rapporterer aktuelle EVALI- eller COVID-19-relaterede symptomer (dvs. hoste, åndenød, brystsmerter, kvalme, opkastning, mavesmerter, diarré, feber, kulderystelser eller vægttab)
- Personer, der har eller har været udsat for COVID-19 inden for de seneste 14 dage.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Partial Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration
For the partial nicotine reduction study, participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods (JUUL/NJOY) ad libitum for up to 60 minutes.
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Partial Nicotine Reduction: Effects of e-cigarette pods (JUUL/NJOY) with 5% nicotine concentration nicotine concentration
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Eksperimentel: Partial Nicotine Reduction: Electronic cigarette pods with 3% or 2.4% nicotine concentration
For the partial nicotine reduction study, participants will complete a lab visit where they will use 3% or 2.4% nicotine electronic cigarette pods (JUUL/NJOY) ad libitum for up to 60 minutes.
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Partial Nicotine Reduction: Effects of e-cigarette pods (JUUL/NJOY) with 3% or 2.4% nicotine concentration
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Eksperimentel: Total Nicotine Reduction: Electronic cigarette pods with 5% nicotine concentration
For the total nicotine reduction study, participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods (SREC) ad libitum for up to 60 minutes.
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Total Nicotine Reduction: Effects of e-cigarette pods (SREC) with 5% nicotine concentration
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Eksperimentel: Total Nicotine Reduction: Electronic cigarette pods with 0% nicotine concentration
For the total nicotine reduction study, participants will complete a lab visit where they will use 0% nicotine electronic cigarette pods (SREC) ad libitum for up to 60 minutes.
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Total Nicotine Reduction: Effects of e-cigarette pods (SREC) with 0% nicotine concentration nicotine concentration
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Plasma Nicotine Boost
Tidsramme: During the 2 participant visits, blood was taken 2 times in each session: before and after approximately 60 minutes ad lib use.
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Change in plasma nicotine level.
The plasma nicotine boost was calculated by subtracting the preplasma nicotine value from the postplasma value.
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During the 2 participant visits, blood was taken 2 times in each session: before and after approximately 60 minutes ad lib use.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Puff Topography (Total Puffing Time)
Tidsramme: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior in total puffing time
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Puff Topography (Average Puff Duration)
Tidsramme: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior in average puffing duration
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Puff Topography (Puff Number)
Tidsramme: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior; mean of the number of puffs taken during the ad-libitum smoking session
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Puff Topography (Inhaled Volume)
Tidsramme: During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Measurement of puffing behavior; mean volume of puffs inhaled during the ad-libitum smoking session
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During participants' 2 study visits. Puffing behavior is continuously measured during each electronic cigarette use session (an approximately 60 minutes ad lib use period)
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Toxicants (Carcinogenic and Probably or Possibly Carcinogenic) Exposure
Tidsramme: During the 2 participant visits for both trials (partial and total). Toxicant exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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This aim elucidates how compensatory puffing behavior in response to NR affects exposure to pulmonary toxicants.
The analytical assessments were conducted at the AUB Aerosol Research Laboratory (ARL) using the Aerosol Lab Vaping Instrument (ALVIN).
The ALVIN is programmed to playback participants' puffing behavior recorded during their two sessions (for both partial and total nicotine reduction studies) to generate and sample the e-cigarette aerosol for analysis.
The ARL is equipped with gas chromatographs with a flame ionization detector and a mass spectrometer (GC-FID, GC-MS), as well as and High-performance liquid chromatography Mass Spectrometry (HPLC-MS) for aldehydes analysis.
ARL optimized analytical methods have been used in several NIH-funded studies of ENDS nicotine and aldehydes emissions.
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During the 2 participant visits for both trials (partial and total). Toxicant exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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TPM (Total Particular Matter) Exposure
Tidsramme: During the 2 participant visits for both trials (partial and total). Total Particular Matter exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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This aim elucidates how compensatory puffing behavior in response to NR affects exposure to pulmonary toxicants.
The analytical assessments were conducted at the AUB Aerosol Research Laboratory (ARL) using the Aerosol Lab Vaping Instrument (ALVIN).
The ALVIN is programmed to playback participants' puffing behavior recorded during their two sessions (for both partial and total nicotine reduction studies) to generate and sample the e-cigarette aerosol for analysis.
The ARL is equipped with gas chromatographs with a flame ionization detector and a mass spectrometer (GC-FID, GC-MS), as well as and High-performance liquid chromatography Mass Spectrometry (HPLC-MS) for aldehydes analysis.
ARL optimized analytical methods have been used in several NIH-funded studies of ENDS nicotine and aldehydes emissions.
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During the 2 participant visits for both trials (partial and total). Total Particular Matter exposure was measured after an approximately 60 minutes ad lib electronic cigarette use period.
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Lung Function Tests (LFTs) Change
Tidsramme: During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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LFTs (i.e., lung volume testing, airway resistance, specific airway conductance) will be measured before and immediately after ENDS use.
According to 2019 American Thoracic Society and European Respiratory Society recommendation simple spirometry (e.g., change in FVC and FEV1) will be performed.
Note: This outcome is not involved in multiple assessments since all the values will appear on the spirometry at the same time.
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During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Lung Function Tests (LFTs) (% Predicted Change)
Tidsramme: During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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LFTs (i.e., lung volume testing, airway resistance, specific airway conductance) will be measured before and immediately after ENDS use.
According to 2019 American Thoracic Society and European Respiratory Society recommendation simple spirometry (e.g., % predicted value pred (FVC), FEV1 % pred FEV1/FVC, % pred) will be performed.
Note: This outcome is not involved in multiple assessments since all the values will appear on the spirometry at the same time.
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During participants' 2 study visits. Lung function tests will be measured 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Minnesota Nicotine Withdrawal Scale (MNWS)
Tidsramme: During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Nicotine withdrawal symptoms were measured using the Minnesota Nicotine Withdrawal Scale (MNWS) before and after each vaping session.
MNWS evaluates 11 withdrawal-related symptoms, including depressed mood, irritability, restlessness, hunger, and difficulty concentrating, using scale from "0" (not at all) to "100" (extremely).
For each session and condition, change scores were calculated by subtracting pre-session from post-session scores for each individual item
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During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Tiffany-Drobes Questionnaire of Smoking Urges (QSU)
Tidsramme: During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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The Tiffany-Drobes Questionnaire of Smoking Urges-Brief (QSU-Brief) is a 10-item self-report measure of cigarette craving and urge to smoke. It consists of two subscales representing distinct dimensions of craving: Factor 1 (Desire and Intention to Smoke): assesses desire, intention, and anticipation of pleasure associated with smoking. Factor 2 (Anticipation of Relief from Negative Affect and Withdrawal): assesses expectations that smoking will relieve withdrawal symptoms or negative affect. Each item is rated on a 7-point Likert scale ranging from 1 = strongly disagree to 7 = strongly agree. Subscale scores were calculated by averaging the items within each factor. Higher scores on either factor indicate greater smoking urge or craving, representing a worse outcome, whereas lower scores indicate lower craving or urge to smoke, representing a better outcome. Pre- to post-session change scores were calculated as pre-session score minus post-session score for each factor. |
During participants' 2 study visits. Questionnaire will be administered 2 times in each electronic cigarette use session: before and after an approximately 60 minutes ad lib use period
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Duke Sensory Questionnaire (DSQ)
Tidsramme: During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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This scale will assess participants sensory experience of the inhaled product.
The scale has nine items.
All items will be scored on a 7-point Likert scale anchored at the extremes (1= not at all; 7=extremely).
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During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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Modified Cigarette Evaluation Questionnaire (mCEQ)
Tidsramme: During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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Modified Cigarette Evaluation Questionnaire (mCEQ) is used to assess subjective effects associated with ENDS use. The 11-item questionnaire evaluates satisfaction, psychological reward, enjoyment of respiratory tract sensations, craving reduction and aversion. Individual item scores were reported (not subscales). Each item was rated using 7-point Likert scale; 1 = not at all to 7 = extremely. For all items, higher scores indicate greater endorsement of the measured subjective experience, while lower scores indicate less endorsement of that experience. The interpretation depends on the construct being measured: For items assessing satisfaction, enjoyment, psychological reward, sensory experiences, and craving reduction, higher scores indicate greater product reinforcement or abuse liability. For items assessing aversion, higher scores indicate greater unpleasant effects or product aversiveness. |
During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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Visual Analogue Scale (VAS)
Tidsramme: During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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This scale contains 10-item questions to assess users' pleasure and enjoyment using the validated Visual Analog Scale (VAS) post ENDS use sessions.
The scale includes items to assess user's desire, pleasure, satisfaction, future use, and other information rated on an analog scale (0 not at all to 100 extremely).
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During participants' 2 study visits. Questionnaire will be administered after each of the 2 electronic cigarette use sessions. Each session is approximately 60 minutes ad lib use period
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Heart Rate
Tidsramme: During participants' 2 study visits. Heat rate will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Change in heart rate, measured in beats per minute (bpm).
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During participants' 2 study visits. Heat rate will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Blood Pressure (Systolic)
Tidsramme: During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Change in systolic blood pressure, measured in mm/hg.
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During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Blood Pressure (Diastolic)
Tidsramme: During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Change in diastolic blood pressure, measured in mm/hg.
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During participants' 2 study visits. Blood pressure will be measured from baseline and subsequently every 10 minutes until end of vaping session.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Wasim Maziak, PhD, MD, Florida International University
Publikationer og nyttige links
Generelle publikationer
- Ferdous T, Roy S, Chowdhury S, Jebai R, Maya L, DeCaprio AP, Bursac Z, Maziak W. Partial Nicotine Reduction and E-Cigarette Users' Puffing Behaviors Among Adults Aged 21 to 35 Years: A Randomized Crossover Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2422954. doi: 10.1001/jamanetworkopen.2024.22954.
- Roy S, Chowdhury S, Ferdous T, Shihadeh A, Salman R, El Hage R, Salam S, Bursac Z, Maziak W. Predicting nicotine emissions and plasma nicotine boost in E-cigarette users using machine learning. Sci Rep. 2026 Jun 13. doi: 10.1038/s41598-026-57341-4. Online ahead of print.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01DA053587 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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