Understanding Disparities in Quitting in African American and White Smokers
調査の概要
詳細な説明
While many studies have evaluated the use of drugs for quitting smoking among Whites, few have assessed efficacy with AAs. Racial/ethical differences in smoking are well documented. AAs smoke less than White smokers but experience disproportionately greater smoking disease and death.
Past studies by the researchers in this study looked at how effective other smoking cessation methods are in AAs. These methods included nicotine gum, nicotine patch and buproprion sustained release. This study will be evaluating varenicline in both AA and White smokers. There has not been a study conducted yet to prospectively research AA-White differences in smoking cessation and also to examine potential causal pathways explaining AA-White differences in quitting.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Kansas
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Kansas City、Kansas、アメリカ、66160
- University of Kansas Medical Center
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Missouri
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Kansas City、Missouri、アメリカ、64130
- Swope Health Central
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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:
- Non-Hispanic African American or non-Hispanic White
- ≥ 18 years of age
- Smoked 3-20 cigarettes per day
- Smoked on >25 days of the past 30 days
- Functioning telephone
- Interested in quitting smoking
- Interested in taking 3 months of varenicline
- Willing to complete all study visits
Exclusion Criteria:
- Renal impairment
- Evidence or history of clinically significant allergic reactions to varenicline
A cardiovascular event in the past month Hospitalization in the past 2 months for any cardiovascular disease, including but not limited to:
- Angina
- Myocardial infarction
- Peripheral vascular disease
- Stroke
- New onset of chest pain or arrhythmia in the past 2 months
- History of alcohol or drug dependency in the past year
- Major depressive disorder in the last year requiring treatment
- History of panic disorder, psychosis, bipolar disorder, or eating disorders
- Use of tobacco products other than cigarettes in past 30 days
- Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
- Pregnant, contemplating getting pregnant, or breastfeeding
- Plans to move from Kansas City during the treatment and follow-up phase
- Another household member enrolled in the study
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:処理
- 割り当て:非ランダム化
- 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:African American (AA) Smokers
AA smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
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1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
他の名前:
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アクティブコンパレータ:White Smokers
White smokers received 12 weeks of Varenicline and 6 smoking cessation counseling sessions.
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1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
他の名前:
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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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Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26
時間枠:Change from Baseline to Week 26
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Defined as having no cigarettes for the previous 7 days at the Week 26 visit.
The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers.
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Change from Baseline to Week 26
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Nikki Nollen, PhD, MA、University of Kansas Medical Center
出版物と役立つリンク
一般刊行物
- El-Boraie A, Chenoweth MJ, Pouget JG, Benowitz NL, Fukunaga K, Mushiroda T, Kubo M, Nollen NL, Sanderson Cox L, Lerman C, Knight J, Tyndale RF. Transferability of Ancestry-Specific and Cross-Ancestry CYP2A6 Activity Genetic Risk Scores in African and European Populations. Clin Pharmacol Ther. 2021 Oct;110(4):975-985. doi: 10.1002/cpt.2135. Epub 2021 Jan 1.
- Peng AR, Swardfager W, Benowitz NL, Ahluwalia JS, Lerman C, Nollen NL, Tyndale RF. Impact of early nausea on varenicline adherence and smoking cessation. Addiction. 2020 Jan;115(1):134-144. doi: 10.1111/add.14810. Epub 2019 Nov 5.
- Nollen NL, Mayo MS, Saint Onge JM, Scheuermann TS, Cox LS, Chae D, Leavens E, Ahluwalia JS. The effect of area-level disadvantage and race on smoking abstinence in a clinical trial. Exp Clin Psychopharmacol. 2022 Jun;30(3):279-286. doi: 10.1037/pha0000493. Epub 2021 Aug 9.
- Nollen NL, Mayo MS, Sanderson Cox L, Benowitz NL, Tyndale RF, Ellerbeck EF, Scheuermann TS, Ahluwalia JS. Factors That Explain Differences in Abstinence Between Black and White Smokers: A Prospective Intervention Study. J Natl Cancer Inst. 2019 Oct 1;111(10):1078-1087. doi: 10.1093/jnci/djz001.
- Nollen NL, Cox LS, Yu Q, Ellerbeck EF, Scheuermann TS, Benowitz NL, Tyndale RF, Mayo MS, Ahluwalia JS. A clinical trial to examine disparities in quitting between African-American and White adult smokers: Design, accrual, and baseline characteristics. Contemp Clin Trials. 2016 Mar;47:12-21. doi: 10.1016/j.cct.2015.12.001. Epub 2015 Dec 5.
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
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。