Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability
2026年7月21日 更新者：Yoojin Cho、Ohio State University Comprehensive Cancer Center
This randomized, double-blind, crossover human laboratory study compares the abuse liability of cigarettes containing menthol and non-menthol cigarette variants, using the participant's usual brand menthol cigarette as a within-subject reference.
Participants complete standardized laboratory smoking sessions, behavioral economic tasks, and a naturalistic observational period.
The study examines differences in nicotine delivery, smoking behavior, and subjective effects across cigarette types in laboratory and real-world contexts.
調査の概要
状態
まだ募集していません
詳細な説明
Participants complete a three-phase protocol over approximately three weeks, comprising five in-person laboratory visits and two one-week daily-diary periods.
In Phase 1, participants attend a 3-hour baseline laboratory visit after a 12-hour abstinence from nicotine, tobacco, and smoked cannabis. They smoke one usual brand menthol cigarette (UBMC) in a standardized session (10 puffs over 5 minutes) while puff topography is recorded. Serial 3 mL blood samples are collected at -5, +5, +15, +30, and +60 minutes relative to smoking initiation. Subjective effects (e.g., product appeal, sensory perception, craving) are assessed before and after smoking, followed by the Cigarette Purchase Task (CPT). Participants then complete brief surveys three times daily for one week to capture product use and subjective effects in the natural environment.
In Phase 2, participants return for three additional laboratory visits, each separated by at least 48 hours, and smoke one of three blinded study products in a randomized order; study coordinators remain blinded. Each visit follows the Phase 1 procedures (standardized smoking session, topography, serial blood sampling, and subjective ratings). After smoking, participants complete the CPT and the Cross-Price Elasticity Task (CPET), in which the price of UBMC increases while the study product remains fixed, characterizing substitutability.
In Phase 3, participants identify their preferred study product and receive a one-week supply, with instructions to use it exclusively in place of their UBMC. They continue the three-times-daily survey schedule throughout the week. The phase concludes with a final 2-hour laboratory visit including a remaining-cigarette count and the Progressive Ratio Task (PRT), providing a measure of the relative reinforcing value of the preferred study product vs. UBMC.
研究の種類
介入
入学 (推定)
48
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
-
-
Ohio
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Columbus、Ohio、アメリカ、43210
- Ohio State University Comprehensive Cancer Center
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コンタクト：
- Yoo Jin Cho, PhD, MPH
- 電話番号：614-366-7048
- メール：Yoojin.cho@osumc.edu
-
主任研究者：
- Yoo Jin Cho, PhD, MPH
-
-
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:
- Aged 21 years or older
- Currently smoke cigarettes daily (≥ 5 cigarettes/day) for at least the past 6 months, and their usual brand is menthol cigarettes
- Willing to provide informed consent
- Willing to abstain from all nicotine, tobacco, and smoked cannabis products for approximately 12 hours prior to each study visit
- Own and regularly use a functional smartphone compatible with study procedures (e.g., completing daily assessments)
- Willing to complete two weeks of daily assessments involving use of their usual brand menthol cigarettes and the study product
- Able to read, speak, and understand English
Exclusion Criteria:
- Current diagnosis of any significant lung diseases (e.g., asthma, chronic obstructive pulmonary disease, cystic fibrosis)
- History of a cardiac event or episode of cardiac distress (e.g., heart attack, hospitalization for chest pain) within the past 3 months
- Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
- Self-reported use of any non-cigarette nicotine or tobacco product (e.g., e-cigarettes, cigars, oral nicotine products) or cannabis on more than 10 days in the past 30 days
- Self-reported current participation in a smoking cessation program or intention to quit smoking in the next 3 months
- Self-reported difficulty with blood draws
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：防止
- 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 |
|---|---|
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実験的：Study Cigarette A
Participants smoke one Study Cigarette A during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling.
Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session.
Order of exposure to Study Cigarettes A, B, and C is randomized.
|
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
A behavioral economic task administered after each laboratory smoking session.
Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
A behavioral economic task administered after each Phase 2 smoking session.
Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
A concurrent choice task administered at the final laboratory visit.
|
|
実験的：Study Cigarette B
Participants smoke one Study Cigarette B during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling.
Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session.
Order of exposure to Study Cigarettes A, B, and C is randomized.
|
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
A behavioral economic task administered after each laboratory smoking session.
Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
A behavioral economic task administered after each Phase 2 smoking session.
Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
A concurrent choice task administered at the final laboratory visit.
|
|
実験的：Study Cigarette C
Participants smoke one Study Cigarette C during one Phase 2 laboratory session (10 puffs over 5 minutes), with puff topography and serial plasma nicotine sampling.
Subjective effects, the Cigarette Purchase Task, and the Cross-Price Elasticity Task are completed during the session.
Order of exposure to Study Cigarettes A, B, and C is randomized.
|
Exhaled carbon monoxide breath testing and serial 3 mL blood samples collected via indwelling intravenous catheter at -5, +5, +15, +30, and +60 minutes relative to smoking initiation during each laboratory visit.
Self-report questionnaires administered at laboratory visits to assess the subjective effects of each cigarette (e.g., product appeal, sensory perception, satisfaction) using validated instruments such as the Modified Cigarette Evaluation Questionnaire.
A behavioral economic task administered after each laboratory smoking session.
Participants indicate how many cigarettes they would purchase across varying price points to characterize demand for each study product.
A behavioral economic task administered after each Phase 2 smoking session.
Participants choose between their usual brand menthol cigarette (price increasing) and the study product (fixed price), characterizing substitutability.
Brief electronic surveys completed three times daily for one week during Phase 1 (usual brand cigarette use) and Phase 3 (preferred study cigarette use), capturing product use, craving, withdrawal, mood, and subjective effects in the natural environment.
A concurrent choice task administered at the final laboratory visit.
|
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 |
|---|---|---|
|
Plasma nicotine (Cmax)
時間枠：During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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Nicotine delivery will be summarized by Cmax, the maximum nicotine concentration observed in the plasma samples for each participant.
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During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Appeal ratings (Labeled Hedonic Scale)
時間枠：During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
The Labeled Hedonic Scale (LHS) is a self-reported measure of appeal.
Scores range from -100 (most disliked imaginable) to 100 (most liked imaginable) with higher scores indicating a greater degree of liking.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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Puff topography
時間枠：During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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Puffing topography will be summarized with total puff count, average puff duration, average inter-puff interval, average puff volume, total puff volume, average flow rate, and peak flow rate.
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During Phase 1 and 2 smoking sessions, assessed up to 3 weeks
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Sensory effects (general Labeled Magnitude Scale)
時間枠：During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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The general Labeled Magnitude Scale (gLMS) is a 5-item self-report measure of sensory effects.
Scores range from 0 (no sensation) to 100 (strongest imaginable) with higher scores indicating a greater sensation intensity.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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Nicotine craving and withdrawal (Questionnaire of smoking urges)
時間枠：During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Craving relief will be assessed using Questionnaire of Smoking Urges (QSU).
The QSU is made up of 10 statements about the respondent's feelings and thoughts about desire to smoke cigarettes as they are completing the questionnaire.
The scoring comprises of two factors, each the sum of 5 items.
The scores for each factor range from 5-35, and the total score (the sum of all 10 items) ranges from 10-70.
For each factor and for the total score, higher scores indicate more severe urges.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)
時間枠：During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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Withdrawal will be assessed using Minnesota Nicotine Withdrawal Scale (MNWS).
Items are rated on a 5-point scale from 0 (none) to 4 (severe).
MNWS is the sum of 8 items with scores ranging from 0 to 32 with higher scores indicating more severe overall withdrawal.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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Nicotine craving and withdrawal (Minnesota Nicotine Withdrawal Scale)
時間枠：During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
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MNWS-Craving will be calculated which uses a single item from the MNWS that is scored from 0-4 with higher scores indicating greater craving.
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During Phase 1 and 2 smoking sessions and Phase 1 and 3 EMA, assessed up to 3 weeks
|
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Breakpoint
時間枠：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Breakpoint will be defined as the first price at which cigarette consumption is zero during the Cigarette Purchase Task (CPT).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Demand intensity (Q0)
時間枠：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Demand intensity will be defined as cigarette consumption at the lowest cigarette price of $0 during the Cigarette Purchase Task (CPT).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Maximum financial expenditure on cigarettes (Omax)
時間枠：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Participants' reported consumption across different price points from the Cigarette Purchase Task (CPT) will be used to determine the maximum financial expenditure.
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Price at which expenditure is maximized (Pmax)
時間枠：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Participants' reported consumption across different price points from the Cigarette Purchase Task (CPT) will be used to determine the price at which expenditure is maximized.
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Demand elasticity (alpha)
時間枠：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Sensitivity of cigarette consumption to increase in price assessed using the Cigarette Purchase Task (CPT).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
|
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Cross-over price
時間枠：Post Phase 2 smoking sessions, assessed up to 3 weeks
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The price at which two options valued approximately equally will be calculated from the Cross Price Elasticity Task (CPET).
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Post Phase 2 smoking sessions, assessed up to 3 weeks
|
|
Progressive ratio task
時間枠：Post Phase 2 smoking sessions, assessed up to 3 weeks
|
The proportion of puffs allocated to the study products versus usual brand menthol cigarettes (UBMC) will be measured with the Progressive Ratio Task (PRT).
|
Post Phase 2 smoking sessions, assessed up to 3 weeks
|
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Preferred product selection
時間枠：Post Phase 2 smoking sessions, assessed up to 3 weeks
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Count of participants selecting each of the 3 study products after completion of the 3 Phase 2 smoking sessions.
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Post Phase 2 smoking sessions, assessed up to 3 weeks
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Product substitution
時間枠：1 week Phase 3 substitution period
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Substitution assessed via use behavior during Phase 3 will be operationalized as the ratio of study product to UBMC used, with a ratio > 0 indicating any substitution and a ratio > 1 indicating substitution of study product for the UBMC at least 50% of the time.
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1 week Phase 3 substitution period
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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：Yoo Jin Cho, PhD, MPH、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 (推定)
2026年7月27日
一次修了 (推定)
2029年9月30日
研究の完了 (推定)
2029年9月30日
試験登録日
最初に提出
2026年4月27日
QC基準を満たした最初の提出物
2026年4月27日
最初の投稿 (実際)
2026年5月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月22日
QC基準を満たした最後の更新が送信されました
2026年7月21日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- OSU-25014
- K01DA061444 (米国 NIH グラント/契約)
- NCI-2026-01493 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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?
はい
IPD プランの説明
De-identified individual participant data will be archived through the National Addiction & HIV Data Archive Program (NAHDAP) at the Inter-university Consortium for Political and Social Research (ICPSR).
Access requires a Restricted Data Use Agreement.
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。