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의존성과 관련된 주관적 효과에 대한 니코틴 플럭스와 니코틴 형태의 영향 평가

2026년 8월 24일 업데이트: American University of Beirut Medical Center

전자 담배에서 니코틴 전달을 조절하기 위한 잠재적으로 강력한 도구인 니코틴 플럭스: 니코틴 전달 속도와 주관적 효과에 대한 니코틴 플럭스의 중요성

전자 니코틴 전달 시스템(ENDS)은 니코틴 함유 액체를 가열하고 증발시켜 혈액과 뇌에 니코틴을 전달할 수 있는 에어로졸을 생성합니다. ENDS 사용은 지난 10년 동안 특히 청소년 사이에서 급격히 증가했습니다. 미국 고등학생의 20% 이상이 현재 ENDS 사용자이며 이 인구에서 니코틴 의존의 증거가 있습니다. ENDS의 액상 니코틴 농도를 제한하여 ENDS를 "중독성이 현저히 감소하고 청소년에게 매력적으로 보이도록" 하는 연방 법률이 제안되었습니다. 그러나 니코틴 액체 농도를 제한하여 중독을 억제하려는 이러한 노력과 다른 노력은 ENDS의 니코틴 방출이 여러 변수에 의존하기 때문에 성공할 가능성이 낮습니다. 의도된 공중 보건 목표를 달성하기 위해 중독을 대상으로 하는 규제는 니코틴 농도가 아닌 니코틴 전달에 초점을 맞춰야 합니다. 니코틴 전달을 직접 규제할 수는 없지만 ENDS가 니코틴을 방출하는 속도인 "니코틴 플럭스"는 규제할 수 있으며 중요한 것은 몇 가지 장치 설계 및 작동 변수를 기반으로 예측할 수 있습니다. 그러나 현재까지 플럭스와 전달 사이의 관계를 입증하는 경험적 증거는 없으며 니코틴 의존성을 뒷받침하는 주관적 효과와 플럭스 사이의 관계도 없습니다. ENDS를 규제하기 위한 효과적인 프레임워크를 제공하려면 이러한 격차를 줄이는 것이 필수적입니다. American University of Beirut에서 조사관은 니코틴 플럭스, 형태 및 주관적 효과 사이의 관계를 평가할 것입니다. 참가자는 니코틴 플럭스와 형태가 다양한 ENDS 장치를 사용합니다. 흡연 충동, 갈망, 금욕과 같은 의존성 측정이 평가됩니다. 결과는 니코틴 플럭스/형태가 의존성, 퍼핑 강도 및 독성 물질에 대한 노출과 관련된 주관적 영향에 영향을 미치는 정도를 나타냅니다. 요약하면, 이 프로젝트는 공중 보건 기관이 ENDS에서 니코틴 전달을 규제하기 위한 포괄적이고 편리한 구조로서 니코틴 플럭스를 사용하는 데 필요한 실증적 증거를 제공할 것입니다.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

주관적 효과에 대한 니코틴 플럭스와 니코틴 형태의 영향을 평가합니다. AUB에서 조사관은 주관적 효과(예: 제품 선호도, 니코틴 갈망) 및 2개의 플럭스(16 및 32μg/s) x 2가지 형태(양성자화, 자유 염기) 및 0 니코틴 조건. 또한 조사관은 최신 장치를 사용하여 실제 니코틴 플럭스와 형태를 확인하고 폐 독성 물질(카르보닐)에 대한 노출을 측정하기 위해 각 흡입 중에 생성된 에어로졸의 일부를 현장에서 샘플링합니다. 연구자들은 니코틴 플럭스와 양성자화된 니코틴이 증가하면 니코틴 갈망이 더 많이 감소하고 퍼핑 강도와 카르보닐 노출이 낮아질 것이라는 가설을 세웠습니다.

연구 유형

중재적

등록 (실제)

142

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 레바논
    • Beirut
      • Beirut, Beirut, 레바논, 11-0236
        • American University of Beirut

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

설명

포함 기준:

  • 건강하고 18세 이상이어야 합니다.
  • 정보에 입각한 동의를 제공하고, 실험실에 참석하고, 필요에 따라 담배/니코틴을 삼가야 합니다(참가자는 ≥12시간 동안 니코틴/담배 및/또는 ENDS 사용을 삼가도록 지시를 받습니다).
  • 매일 ENDS(≥ 3 mg/ml 니코틴) 또는 담배(빈도 상관없음)를 사용하고 언젠가는 ENDS(≥ 3 mg/ml 니코틴) 또는 담배(모든 빈도) 지난 3개월 이상

제외 기준:

  • 만성 질환의 병력 또는 통제되지 않는 정신과적 상태
  • 활동성 심혈관 질환의 병력 또는 활동성, 저혈압/고혈압, 발작, 정기적인 처방약 복용(비타민/피임 제외)
  • 지난달 코카인, 오피오이드, 벤조디아제핀 또는 메스암페타민 사용
  • 마리화나 사용을 보고한 개인 >15/30일
  • 모유 수유 중이거나 임신 중인 여성은 제외됩니다.
  • 향후 30일 이내에 담배/니코틴 사용을 중단하고 금연 치료를 의뢰한 참여자

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약 - 조합 5 - 0μg/s 니코틴 플럭스
조사관은 니코틴 플럭스(0μg/s) 위약의 주관적 효과를 테스트합니다. 1시간의 관찰 기간 후 참가자는 Subox Mini C를 사용하여 지시에 따라 10회 퍼프(30초 간 퍼프 간격)를 하게 됩니다. 첫 시합 1시간 후, 참가자는 60분 동안 임의로 장치를 퍼핑하도록 지시를 받습니다. 주관적 측정(즉, 니코틴 의존도, 약물 효과, 제품 선호도 및 갈망)은 세션당 5회 시행됩니다: 지정 시합 시작 전 5분 및 시작 후 5분 및 시작 전 5분, 시작 중간 및 시작 후 5분 임의의 한판 승부.
조합 제품: 전자 액체 5
30/70 PG/VG 비율, 니코틴 농도 0mg/ml(위약)
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.
조합 제품: e-liquid 1
30/70 propylene glycol/vegetable glycerin ratio with nicotine concentration 4mg/ml protonated
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.
조합 제품: 전자 액체 2
30/70 PG/VG 비율, 니코틴 농도 10mg/ml 양성자화
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.
조합 제품: 전자 액체 3
니코틴 농도 4mg/ml 유리 염기의 30/70 PG/VG 비율
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.
조합 제품: 전자 액체 4
30/70 PG/VG 비율, 니코틴 농도 10mg/ml 유리염기
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.
조합 제품: e- 액체 6
니코틴 농도 0mg/ml의 30/70 PG/VG 비율
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.
조합 제품: E- 액체 7 및 E- 액체 8
니코틴 농도 4mg/ml 양성자 전자-액체 8 : 30/70 pg/vg 비와 니코틴 농도 8mg/ml 양성자로 E- 액체 7 : 30/70 pg/vg 비율
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.
조합 제품: E- 액체 9 및 E- 액체 10
니코틴 농도 4mg/mL 양성자 전자-액체 10 : 70/30 PG/VG 비와 니코틴 농도 4mg/mL 양성자로 E- 액체 9 : 30/70 PG/VG 비율

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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.
Strong flavor will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating a stronger perceived flavor.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Harshness/Irritancy (Combinations 1-5)
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.
Harshness/irritancy will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating harsher/more irritating effects.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Throat Hit (Combinations 1-5)
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.
Throat hit will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled magnitude scale (gLMS) on a subjective scale (0-10, No sensation - Strongest Imaginable), with higher scores indicating a stronger throat hit.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Overall Like: Flavor (Combinations 1-5)
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.
Overall like: flavor will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the flavor was liked more.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Overall Like: Harshness (Combinations 1-5)
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.
Overall like: harshness will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the harshness was liked more.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Overall Like: Throat Hit (Combinations 1-5)
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.
Overall like: throat hit will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the throat hit was liked more.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Overall Like: Warmth (Combinations 1-5)
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.
Overall like: warmth will be assessed by the Electronic Cigarette Specific Effects questionnaire, general labeled hedonic scale (LHS) on a subjective scale (0-10, most disliked - most liked), with higher scores indicating the warmth was liked more.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Satisfying (Combinations 1-5)
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.
Satisfying will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater satisfaction.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Pleasant (Combinations 1-5)
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.
Pleasant will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater pleasantness.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Taste Good (Combinations 1-5)
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.
Taste good will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating better taste.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Calm (Combinations 1-5)
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.
Calm will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling calmer.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Concentrate (Combinations 1-5)
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.
Concentrate will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating better ability to concentrate.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Awake (Combinations 1-5)
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.
Awake will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling more awake/alert.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Reduce Hunger (Combinations 1-5)
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.
Reduce hunger will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater reduction in hunger.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Dizzy (Combinations 1-5)
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.
Dizzy will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating greater dizziness.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Feeling Sick (Combinations 1-5)
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.
Feeling sick will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating feeling more sick.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Want it Right Now (Combinations 1-5)
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.
Want it right now will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating a stronger immediate desire for the product.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Smell (Combinations 1-5)
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.
Smell will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating a stronger perceived smell. This item is drawn from the Electronic Cigarette Specific Effects Questionnaire, a modified/expanded version of the modified Cigarette Evaluation Questionnaire (mCEQ; Cappelleri et al., 2007) developed for ENDS. Participants rate the item on a 0-10 scale immediately following each bout. Item wording: 'Did the e-cig produce a smell?' (0 = not at all, 10 = extremely).
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Visible Vapor (Combinations 1-5)
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.
Visible vapor will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating more visible vapor.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Importance Vapor (Combinations 1-5)
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.
Importance vapor will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating vapor visibility mattered more to the participant. This item is drawn from the Electronic Cigarette Specific Effects Questionnaire, a modified/expanded version of the modified Cigarette Evaluation Questionnaire (mCEQ; Cappelleri et al., 2007) developed for ENDS. Participants rate the item on a 0-10 scale immediately following each bout. Item wording: 'Is the vapor/cloud of the e-cig important to you?' (0 = not at all, 10 = extremely).
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Subjective Effects - Puffs Similar (Combinations 1-5)
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.
Puffs similar will be assessed by the Electronic Cigarette Specific Effects questionnaire and consists of 1 item scored 0 - 10 with 0 being not at all and 10 being extremely, with higher scores indicating the puffs were perceived as more similar to the participant's usual product.
Post Bout 1: assessed 5 minutes after onset of the directed 10-puff bout (average bout duration ~5 minutes). Post Bout 2: assessed 5 minutes after onset of the 60-minute ad libitum bout.
Smoking Urges - Brief Factor 1 (Intention/Desire)
기간: Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
Brief Factor 1 (Intention/Desire) will be assessed by the Questionnaire of Smoking Urges-Brief (QSU-Brief; Tiffany & Drobes, 1991; Toll et al., 2006). Factor 1 is the sum of 6 items, each rated on a 0-10 scale (0=strongly disagree, 10=strongly agree), yielding a total score range of 0-60, with higher scores indicating stronger urges.
Assessed before and after the directed bout (Bout 1), and before, midway through, and after the ad libitum bout (Bout 2).
Smoking Urges - Brief Factor 2 (Relief of Neg. Affect)
기간: 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)
기간: 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).

2차 결과 측정

결과 측정
측정값 설명
기간
Puff Duration
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
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
Puff Duration - Combination 6,7 & 8
기간: 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)
기간: 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)
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
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
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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

American University of Beirut Medical Center

협력자

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)

수사관

  • 수석 연구원: Soha Talih, PhD, American University of Beirut Medical Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 7월 13일

기본 완료 (실제)

2025년 7월 11일

연구 완료 (실제)

2025년 7월 11일

연구 등록 날짜

최초 제출

2022년 6월 8일

QC 기준을 충족하는 최초 제출

2022년 6월 20일

처음 게시됨 (실제)

2022년 6월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 24일

마지막으로 확인됨

2025년 2월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

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?

아니요

IPD 계획 설명

참가자 데이터는 다른 연구원이 사용할 수 없습니다.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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