The Abuse Liability of IQOS Heated Tobacco Products Among Adults Who Smoke
2026年8月27日 更新者：Alayna Tackett、Ohio State University Comprehensive Cancer Center
Studying User Sensory Experiences and Smoking Behavior of IQOS Heated Tobacco Products to Improve Harm Reduction Among Adult Cigarette Smokers
This clinical trial aims to evaluate user sensory experiences and smoking behavior when using IQOS heated tobacco products (HTPs) among adults who smoke cigarettes.
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. Assess the abuse liability (appeal and sensory effects) of IQOS. II. Examine the puffing topography of IQOS.
SECONDARY OBJECTIVES:
I. Evaluate the impact of flavor on the sensory effects, appeal, and puffing topography of IQOS.
II. Evaluate the effect of perceived harm on IQOS use behavior.
EXPLORATORY OBJECTIVE:
I. Examine acute changes to pulmonary health associated with IQOS use.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants use IQOS HeatSticks (flavor matched to their usual cigarette) as much as desired (ad lib) over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants smoke their usual brand cigarette (UBC) ad lib over 60 minutes during laboratory visit 2.
ARM II: Participants smoke their UBC ad lib over 60 minutes during laboratory visit 1. At least forty-eight hours later, participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 2.
研究の種類
介入
入学 (推定)
30
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。
研究連絡先
- 名前：The Ohio State University Comprehensive Cancer Center
- 電話番号：800-293-5066
- メール：OSUCCCClinicaltrials@osumc.edu
研究場所
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Ohio
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Columbus、Ohio、アメリカ、43210
- 募集
- Ohio State University Comprehensive Cancer Center
-
主任研究者：
- Alayna P. Tackett, PhD
-
コンタクト：
- Alayna P. Tackett, PhD
- 電話番号：844-744-2447
- メール：Tackett-Lab@osumc.edu
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Adults 21-65 years
- Adults who smoke (defined as ≥ 5 days weekly use of either menthol or non-menthol cigarettes over the past 3 months)
- Willing to provide informed consent and abstain from using nicotine products 12 hours before each visit
- Willing to bring UBC to each study visit
- Read, write and speak English
Exclusion Criteria:
- Current use of other non-combustible nicotine products (e.g., electronic [e]-cigarettes, HTPs; [defined as ≥ 5 days weekly use in the past 30 days])
- Planning to quit nicotine use and/or use of any smoking cessation medication in the past 30 days
- Current diagnosis of any lung diseases (e.g., asthma, cystic fibrosis, or chronic obstructive pulmonary disease)
- Self-reported unstable or significant psychiatric conditions (past/stable conditions will be allowed)
- History of cardiac event or distress within the past 3 months
- Deaf, hard of hearing, or have a severe motor disability
- Are currently pregnant, planning to become pregnant, or breastfeeding (urine pregnancy test will be completed at each visit throughout the study)
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Arm I (IQOS HeatSticks, Usual Brand Cigarette [UBC])
Participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 1.
At least forty-eight hours later, participants smoke their UBC ad lib over 60 minutes during laboratory visit 2.
|
Use IQOS HeatSticks (flavor matched to the participant's usual cigarette)
Smoke UBC
|
|
他の：Arm II (UBC, IQOS HeatSticks)
Participants smoke their UBC ad lib over 60 minutes during laboratory visit 1.
At least forty-eight hours later, participants use IQOS HeatSticks (flavor matched to their usual cigarette) ad lib over 60 minutes during laboratory visit 2.
|
Use IQOS HeatSticks (flavor matched to the participant's usual cigarette)
Smoke UBC
|
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 |
|---|---|---|
|
Product Appeal
時間枠：Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
|
Participants will complete the Appeal and Sensory Quality questionnaire.
This questionnaire will ask participants to rate each study product for appeal characteristics such as liking, willingness to use again, flavor intensity, pleasantness of taste, etc. on a scale of 0 (not at all) - 100 (extremely).
Higher scores indicate greater liking, willingness to use again, flavor intensity, etc.
|
Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
|
|
Product Sensory Attributes
時間枠：Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
|
Participants will rate sensory attributes using the Appeal and Sensory Quality questionnaire.
This questionnaire will ask participants to rate each study product for sensory attributes such as harshness, coolness, sweetness, etc. on a scale of 0 (not at all) - 100 (extremely).
Higher scores indicate greater harshness, coolness, sweetness, etc.
|
Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
|
|
Economic demand breakpoint
時間枠：Minute 60 of product use session
|
The price point at which a participant is no longer willing to pay for a stick of the study product will be determined by using a cigarette purchase task questionnaire.
|
Minute 60 of product use session
|
|
Satisfaction and psychological reward
時間枠：Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
|
Satisfaction and psychological reward of study product use will be measured by the Modified Cigarette Evaluation Questionnaire (mCEQ).
The mCEQ asks questions relating to satisfaction of using the study product on a scale from 0 (Not at all) - 6 (Extremely).
|
Minute 5 of product use session, Minute 35 of product use session, Minute 60 of product use session
|
|
Abuse Liability Via Puff Topography - Total Smoking Time
時間枠：Minute 60 of product use session
|
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs.
These measures are combined to inform overall cigarette puff behavior.
|
Minute 60 of product use session
|
|
Abuse Liability Via Puff Topography - Average Puff Duration
時間枠：Minute 60 of product use session
|
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs.
These measures are combined to inform overall cigarette puff behavior.
|
Minute 60 of product use session
|
|
Abuse Liability Via Puff Topography - Average Flow Rate
時間枠：Minute 60 of product use session
|
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs.
These measures are combined to inform overall cigarette puff behavior.
|
Minute 60 of product use session
|
|
Abuse Liability Via Puff Topography - Average Inter-Puff Interval
時間枠：Minute 60 of product use session
|
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs.
These measures are combined to inform overall cigarette puff behavior.
|
Minute 60 of product use session
|
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Abuse Liability Via Puff Topography - Average Puff Volume
時間枠：Minute 60 of product use session
|
Will be measured with a topography device that records frequency, duration, and flow rate of cigarette puffs.
These measures are combined to inform overall cigarette puff behavior.
|
Minute 60 of product use session
|
|
Craving/withdrawal
時間枠：Minute 0 before product use session, Minute 5 of product use session, Minute 35 of product use session, minute 60 of product use session
|
Nicotine withdrawal and craving symptoms will be measured using the Minnesota Nicotine Withdrawal Scale (MNWS)
|
Minute 0 before product use session, Minute 5 of product use session, Minute 35 of product use session, minute 60 of product use session
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Spirometry FEV1
時間枠：Minute 0 before start of product use session and minute 60 of product use session
|
Spirometry will be used to measure forced expiratory volume (FEV1)
|
Minute 0 before start of product use session and minute 60 of product use session
|
|
Spirometry FVC
時間枠：Minute 0 before start of product use session, Minute 60 of product use session
|
Spirometry will be used to measure forced vital capacity (FVC)
|
Minute 0 before start of product use session, Minute 60 of product use session
|
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Spirometry FEV1/FVC
時間枠：Minute 0 before start of product use session, Minute 60 of product use session
|
Spirometry will be used to measure FEV1/FVC
|
Minute 0 before start of product use session, Minute 60 of product use session
|
|
Used filter count
時間枠：Minute 60 of product use session
|
Will assess the number of study product consumed
|
Minute 60 of product use session
|
|
Harm Perception
時間枠：Minute 60 of product use session
|
A harm perception questionnaire will be used to assess the relative and absolute perceived harm of IQOS products.
|
Minute 60 of product use session
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Alayna P Tackett, PhD、Ohio State University Comprehensive Cancer 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。
便利なリンク
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)
2026年8月27日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2027年10月1日
試験登録日
最初に提出
2026年6月26日
QC基準を満たした最初の提出物
2026年7月6日
最初の投稿 (実際)
2026年7月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月31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27日
最終確認日
2026年8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
- OSU-26080
- U54CA287392 (米国 NIH グラント/契約)
- NCI-2026-04495 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- STUDY20260624 (その他の識別子：Ohio State University Comprehensive Cancer Center)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。