Switching to Reduced Oxidant or Nicotine Content Cigarettes in Smokers
Switching to Reduced Nicotine Content Cigarettes or Reduced Reactive Oxygen/Reactive Nitrogen Species Cigarettes in Smokers
調査の概要
詳細な説明
Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between 21-65 who smoke any of the following brands on a regular basis: Marlboro Red, Marlboro Menthol, Pall Mall Red, Pall Mall Menthol, Kool Menthol, Salem Menthol, L&M Menthol, Pyramid Red, Newport Red, Newport Menthol.
If you smoke one of these brand styles on a regular basis you may be eligible to participate in a compensated short term study on health and smoking behavior at Penn State Hershey Medical Center.
Study participation lasts 22 days, with 4 study visits at the Medical Center. Smokers are asked to use their usual brand for one week and then switch to 1 of 3 brands for the remaining two weeks. The three brands participants are randomly assigned to after the first week of participation are either Group 1. reduced nicotine content cigarette (Spectrum Research Cigarettes) or Group 2. reduced oxidant cigarette (American Spirit) or assigned to Group 3. usual brand. Whichever group you are assigned to, you will be asked to smoke only these until the end of the study. All cigarettes following visit 1 will be provided free of charge.
Study overview:
Visit 1/ Duration: 60 minutes Provide a blood and urine sample Complete a 20 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 2: Randomized Phase /Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 3/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Use a simple, hand held smoking device to smoke all cigarettes for 2 days Collect cigarette butts on 1 day
Visit 4/ Duration: 20-30 minutes Provide a blood and urine sample Complete a 10 minute interview Sign compensation form
For information on additional tobacco studies being conducted at Penn State Hershey, please call 1-844-207-6392
*This research is being conducted under the investigator John Richie at Penn State Hershey; 500 University Drive Hershey, PA
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033
- Penn State Hershey
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 21-65
- Smoke 10 cigarettes/day or more for at least one year
- Read and write in English
- Menthol and nonmenthol smokers who use relatively high nicotine and ROS/RNS cigarettes
- Able to understand and provide consent to study procedures
- Plan to live in the local area for the next month
- Women not pregnant or nursing and taking steps to avoid pregnancy
- No quit attempt in the last one months and not planning to quit in the next month
Exclusion Criteria:
- Currently pregnant or nursing
- Unstable or significant medical condition, such as COPD or kidney failure, that is likely to affect biomarker data
- Use of non-cigarette nicotine delivery product in the past week (included cigars, pipes, chew, snus, hookah, e-cig, and marijuana)
- Currently reducing or planning to reduce cigarette consumption in the next month
- Use of smoking cessation medicine in the past 3 months
- History of difficulties providing blood samples: fainting, poor veins, anxiety, etc.
- Uncontrolled serious psychotic illness or substance abuse or inpatient treatment for these in the last 6 months (substance abuse includes weekly, almost daily or daily use of other illegal drugs and prescription drugs that are not being used for medically prescribed purposes or alcohol abuse that would hinder the participant's ability to participate)
- Significant medical condition, i.e. stroke, MI, cancer, in the last month
- Currently using illegal drugs
研究計画
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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実験的：Reduced Nicotine Cigarettes
Participants will be randomized to receive low nicotine cigarettes to replace their usual high nicotine brand.
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Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization.
Select biosamples of participants will be used to analyze how biomarkers differ among groups
他の名前：
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実験的：Reduced ROS/RNS
Participants will be randomized to receive Reduced Oxidative/Nitrogen Species (ROS/RNS) cigarettes to replace their usual cigarettes.
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Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization.
Select biosamples of participants will be used to analyze how biomarkers differ among groups
他の名前：
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プラセボコンパレーター：Control Group
Participants will be assigned to continue smoking their usual brand of cigarettes.
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Human topography data will show if smokers change the way they smoke due to being in a research study.
Select biosamples of participants will be used to analyze how biomarkers differ among groups
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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 |
|---|---|---|
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Smoking Topography
時間枠：8 days
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measures of smoking topography include parameters such as puff volume, frequency and intensity as measured using a smoking topography instrument.
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8 days
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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 |
|---|---|---|
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Biomarkers of oxidative stress
時間枠：4 times over the 22 day study period
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biomarkers of oxidative stress are as followed: glutathionylated and cysteinylated proteins in blood and F2-isoprostanes and 8-hydroxydeoxyguanosine (8-OHdG).
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4 times over the 22 day study period
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協力者と研究者
協力者
捜査官
- 主任研究者：John Richie, Ph.D、Milton S. Hershey Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY00001996
- 5P50DA036107-02 (米国 NIH グラント/契約)
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。
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