의존성과 관련된 주관적 효과에 대한 니코틴 플럭스와 니코틴 형태의 영향 평가
전자 담배에서 니코틴 전달을 조절하기 위한 잠재적으로 강력한 도구인 니코틴 플럭스: 니코틴 전달 속도와 주관적 효과에 대한 니코틴 플럭스의 중요성
Electronic nicotine delivery systems (ENDS) heat and vaporize a nicotine-containing liquid to produce an aerosol that can deliver nicotine to the blood and the brain. ENDS use has increased rapidly in the last decade, especially among youth: over 20% of US high school students are current ENDS users, and there is evidence of nicotine dependence in this population. Federal legislation has been proposed that would restrict ENDS liquid nicotine concentration to make ENDS "significantly less addictive and appealing to youth." However, these and other efforts to curb addiction by limiting nicotine liquid concentration are unlikely to succeed because nicotine emissions from ENDS depend on multiple variables. To achieve the intended public health aims, regulations targeting addiction must focus on nicotine delivery, not nicotine concentration. While nicotine delivery cannot be regulated directly, the rate at which an ENDS emits nicotine, the "nicotine flux", can be regulated and, importantly, predicted based on a few device design and operating variables. However, to date there is no empirical evidence demonstrating the relationship between flux and delivery, nor between flux and the subjective effects that support nicotine dependence. Closing this gap is essential for providing an effective framework for regulating ENDS. At the American University of Beirut, the investigators will assess the relationship between nicotine flux, form, and subjective effects. Participants will use ENDS devices with varying nicotine fluxes and forms. Dependency measures, such as urge to smoke, craving, and abstinence, will be assessed. The outcome will indicate the degree to which nicotine flux/form influence subjective effects related to dependency, puffing intensity, and exposure to toxicants. In summary, this project will provide the empirical evidence needed for public health agencies to use nicotine flux as an encompassing and convenient construct to regulate nicotine delivery from ENDS.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Assess the influence of nicotine flux and nicotine form on subjective effects. At AUB, the investigators will assess subjective effects (e.g. product liking, nicotine craving) and puffing topography for 130 participants who will undergo 5 ENDS use sessions (combinations 1-5) consisting of 2 bouts (10 puffs + 60min ad libitum) with 2 fluxes (15 and 35μg/s) x 2 forms (protonated, freebase) and a 0 nicotine condition. In addition, the investigators will use a state-of-the-art device to sample in situ a fraction of the aerosol generated during each puff to verify actual nicotine flux and form, and measure exposure to pulmonary toxicants (carbonyls). The investigators hypothesize that increasing nicotine flux and protonated nicotine will result in greater reductions of nicotine craving, and lower puffing intensity and carbonyl exposure. 10 of the participants that completed AIM 2 will be asked to attend our lab at AUB for one additional visit, where they will be assigned either a high flow or low flow ENDS. During the visit, participants will undertake three smoking bouts consisting of 10 puffs each, where they will be presented with alternating puffs of the assigned device in which a specific ENDS design variable is systematically varied between puffs. Puff topography, inhalation behavior, and subjective effects related to sensory feedback will be recorded. We hypothesize that power and liquid composition variations will result in immediate and reversible changes in puffing/inhalation behavior.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Beirut
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Beirut, Beirut, 레바논, 11-0236
- American University of Beirut
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Must be healthy and above 18 years of age
- Must be willing to provide informed consent, attend the lab, and abstain from tobacco/nicotine as required (participants will be instructed to abstain from nicotine/tobacco and/or ENDS use for ≥12h)
- A dual ENDS and tobacco user who reports daily use of ENDS (≥ 3 mg/ml nicotine) or cigarettes (any frequency) AND someday use (≥ 3 days/week) of ENDS (≥ 3 mg/ml nicotine) or cigarettes (any frequency) for the past 3 months or longer
Exclusion Criteria:
- History of chronic disease or an uncontrolled psychiatric condition
- History of or active cardiovascular disease, low/high blood pressure, seizures, regular use of a prescription medication (except vitamins/birth control)
- Past month use of cocaine, opioids, benzodiazepines, or methamphetamines
- Individuals who report using marijuana >15/30 days
- Women will be excluded if they are breast-feeding or pregnant
- Participants intending to quit tobacco/nicotine use in the next 30 days and referred to cessation treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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 |
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실험적: 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. |
30/70 PG/VG ratio with nicotine concentration 10mg/ml protonated |
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실험적: 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. |
30/70 PG/VG ratio with nicotine concentration 4mg/ml free base |
|
실험적: 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. |
30/70 PG/VG ratio with nicotine concentration 10mg/ml freebase |
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위약 비교기: Placebo - Combination Five - 0μg/s nicotine flux
The investigators will test the subjective effects of nicotine flux (0μg/s) placebo. 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 PG/VG ratio with nicotine concentration 0mg/ml (placebo) |
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실험적: 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. |
30/70 PG/VG ratio with nicotine concentration 0mg/ml |
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실험적: 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. |
e-liquid 7: 30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated e-liquid 8: 30/70 PG/VG ratio with nicotine concentration 8mg/ml protonated |
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실험적: 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. |
e-liquid 9: 30/70 PG/VG ratio with nicotine concentration 4mg/ml protonated e-liquid 10: 70/30 PG/VG ratio with nicotine concentration 4mg/ml protonated |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Subjective Effects - Strong Flavor (Combinations 1-5)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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. |
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)
기간: 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). |
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)
기간: 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. |
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)
기간: 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). |
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)
기간: 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. |
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)
기간: Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Brief Factor 1 (Intention/Desire) will be assessed by the Questionnaire of Smoking Urges-Brief (QSU-Brief; Tiffany & Drobes, 1991; Toll et al., 2006). Factor 1 is the sum of 6 items, each rated on a 0-10 scale (0=strongly disagree, 10=strongly agree), yielding a total score range of 0-60, with higher scores indicating stronger urges. |
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)
기간: Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Brief Factor 2 (Relief of Neg. Affect) will be assessed by the Questionnaire of Smoking Urges-Brief (QSU-Brief; Tiffany & Drobes, 1991; Toll et al., 2006). Factor 2 is the sum of 4 items, each rated on a 0-10 scale (0=strongly disagree, 10=strongly agree), yielding a total score range of 0-40, with higher scores indicating stronger urges. |
Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
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Withdrawal Symptoms - Minnesota Nicotine Withdrawal Scale (MNWS; Based on Hughes and Hatsukami, 1986)
기간: 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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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).
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Puff Duration
기간: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
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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
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Number of Puffs
기간: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
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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
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Puffing Time
기간: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
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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
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Inter Puff Interval
기간: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
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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
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Flow Rate
기간: Will be measured during the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
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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
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Mouth-level PM
기간: Will be measured after the approximately 5-minute, 10-puff use bout and 60-minute, ad lib use bout
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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
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Mouth-level Nicotine
기간: 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
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Puff Duration - Combination 6,7 & 8
기간: Will be measured during the approximately 5-minute, 10-puff use bout
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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
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Sensory Feedback - Perceived Mouthful - Using Kangertech Subox Mini C (Sub-ohm Device)
기간: Will be measured during the approximately 5-minute, 10-puff use bout
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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
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Sensory Feedback - Perceived Draw Effort - Using Kangertech Subox Mini C (Sub-ohm Device)
기간: 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
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Sensory Feedback - Throat Hit - Using Kangertech Subox Mini C (Sub-ohm Device)
기간: Will be measured during the approximately 5-minute, 10-puff use bout
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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
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Soha Talih, PhD, American University of Beirut Medical Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- American University Of Beirut
- 1R01DA052565-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Participants data will not be available to other researchers
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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