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依存性に関連する主観的影響に対するニコチンの流動とニコチンの形態の影響を評価する

ニコチンフラックス、電子タバコからのニコチン送達を調節するための潜在的に強力なツール: ニコチン送達速度および主観的効果に対するニコチンフラックスの重要性

電子ニコチン送達システム (ENDS) は、ニコチンを含む液体を加熱して蒸発させ、ニコチンを血液と脳に送達できるエアロゾルを生成します。 ENDS の使用は、ここ 10 年で特に若者の間で急速に増加しています。米国の高校生の 20% 以上が現在の ENDS ユーザーであり、この人口にニコチン依存症があるという証拠があります。 ENDSを「中毒性を大幅に軽減し、若者にとって魅力的なものにする」ために、ENDSの液体ニコチン濃度を制限する連邦法が提案されている。 しかし、ENDSからのニコチン排出量は複数の変数に依存するため、ニコチン液体濃度を制限することで依存症を抑制するこれらの取り組みやその他の取り組みは成功する可能性は低いです。 意図された公衆衛生上の目的を達成するには、依存症を対象とした規制は、ニコチン濃度ではなくニコチンの放出に焦点を当てなければなりません。 ニコチンの送達を直接制御することはできませんが、ENDS がニコチンを放出する速度、「ニコチン フラックス」は制御でき、重要なことに、いくつかのデバイス設計と動作変数に基づいて予測できます。 しかし、今日まで、ニコチン依存を裏付けるフラックスと送達との関係、またはフラックスと主観的効果との関係を証明する経験的証拠は存在しない。 このギャップを埋めることは、ENDS を規制するための効果的な枠組みを提供するために不可欠です。 ベイルートのアメリカン大学では、研究者らはニコチンの流出、形態、および主観的効果の間の関係を評価する予定である。 参加者は、さまざまなニコチンのフラックスと形態を備えた ENDS デバイスを使用します。 喫煙への衝動、渇望、禁欲などの依存性の尺度が評価されます。 結果は、ニコチンの流動/形態が、依存性、一服の強さ、有毒物質への曝露に関連する主観的影響にどの程度影響するかを示します。 要約すると、このプロジェクトは、公衆衛生機関がENDSからのニコチン送達を規制するための包括的かつ便利な構造としてニコチンフラックスを使用するために必要な経験的証拠を提供することになる。

調査の概要

詳細な説明

主観的効果に対するニコチンの流動とニコチンの形態の影響を評価します。 AUB では、研究者は主観的な効果 (例: 2つのフラックス(16および32μg/s)×2つの形態(プロトン化、遊離塩基)を使用した2試合(10パフ+60分間自由)からなる5回のENDS使用セッションを受ける130人の参加者を対象に、製品の好み、ニコチンへの渇望)およびパフのトポグラフィーを測定しました。ニコチンゼロの状態。 さらに、研究者らは最先端の装置を使用して、各吸気中に生成されるエアロゾルの一部をその場でサンプリングし、実際のニコチンの流入と形態を検証し、肺毒性物質(カルボニル)への曝露を測定します。 研究者らは、ニコチンの流入とプロトン化ニコチンの増加により、ニコチンへの渇望が大幅に減少し、一服の強度とカルボニルへの曝露が低下するだろうと仮説を立てています。

研究の種類

介入

入学 (実際)

142

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Beirut
      • Beirut、Beirut、レバノン、11-0236
        • American University of Beirut

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

説明

包含基準:

  • 健康で18歳以上でなければなりません
  • インフォームド・コンセントを提供し、ラボに出席し、必要に応じてタバコ/ニコチンを控える意欲がなければなりません(参加者はニコチン/タバコおよび/またはENDSの使用を12時間以上控えるよう指示されます)
  • ENDS (ニコチン 3 mg/ml 以上) または紙巻きタバコ (任意の頻度) を毎日使用し、かついつか ENDS (ニコチン 3 mg/ml 以上) または紙巻きタバコ (任意の頻度) を使用する (週に 3 日以上) と報告する、ENDS とタバコの二重使用者頻度) 過去 3 か月以上

除外基準:

  • 慢性疾患または制御されていない精神疾患の病歴
  • 心血管疾患の病歴または活動性、低血圧/高血圧、発作、処方薬の定期的使用(ビタミン剤/避妊薬を除く)
  • 過去 1 か月間のコカイン、オピオイド、ベンゾジアゼピン、またはメタンフェタミンの使用
  • 15日/30日を超えるマリファナの使用を報告した個人
  • 授乳中または妊娠中の女性は除外されます
  • 今後 30 日間にタバコ/ニコチンの使用をやめるつもりがあり、禁煙治療を参照した参加者

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター:プラセボ - 組み合わせ 5 - 0μg/s ニコチン流量
研究者らは、ニコチン流入(0μg/秒)のプラセボの主観的効果をテストする予定です。 1 時間の観察期間の後、参加者は Subox Mini C を使用して、10 パフ指示 (パフ間隔 30 秒) の試合を行います。 最初の試合の 1 時間後、参加者はデバイスを 60 分間自由に吸うように指示されます。 主観的測定値(つまり、ニコチン依存症、薬物効果、製品の好み、および渇望)は、セッションあたり 5 回投与されます:指示された試合の開始の 5 分前と開始後 5 分、および指示された試合の開始の 5 分前、途中、および開始後の 5 分アドリブの試合。
PG/VG 比 30/70、ニコチン濃度 0mg/ml (プラセボ)
実験的: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
実験的: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.
PG/VG 比 30/70、ニコチン濃度 10mg/ml プロトン化
実験的: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.
PG/VG 比 30/70、ニコチン濃度 4mg/ml 遊離塩基
実験的: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.
PG/VG 比 30/70、ニコチン濃度 10mg/ml 遊離塩基
実験的: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.
ニコチン濃度0mg/mlの30/70 pg/vg比
実験的: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比ニコチン濃度4mg/mlプロトン化E-liquid 8:30/70 pg/vg比とニコチン濃度8mg/mlプロトン化
実験的: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比ニコチン濃度4mg/mlプロトン化E-liquid 10:70/30 pg/vg比4mg/mlプロトン化

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Subjective Effects - Strong Flavor (Combinations 1-5)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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).

二次結果の測定

結果測定
メジャーの説明
時間枠
Puff Duration
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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

協力者と研究者

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捜査官

  • 主任研究者:Soha Talih, PhD、American University of Beirut Medical Center

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年7月13日

一次修了 (実際)

2025年7月11日

研究の完了 (実際)

2025年7月11日

試験登録日

最初に提出

2022年6月8日

QC基準を満たした最初の提出物

2022年6月20日

最初の投稿 (実際)

2022年6月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月18日

QC基準を満たした最後の更新が送信されました

2026年8月24日

最終確認日

2025年2月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • American University Of Beirut
  • 1R01DA052565-01A1 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

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いいえ

IPD プランの説明

参加者のデータは他の研究者が利用することはできません

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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