Improving Varenicline Adherence and Outcomes in Homeless Smokers
調査の概要
状態
条件
詳細な説明
Despite significant declines in cigarette smoking rates among adults in the United States in the last few decades, smoking rates remain high among poor and underserved populations. One underserved group is the 4 million homeless persons in the US among whom cigarette smoking rate is an alarming 70% or more; these rates are 3 times higher than national average. Two of the three leading causes of death among homeless persons, heart disease and cancer are tobacco related.2, 3 Despite very high smoking prevalence and disease burden in this population smoking cessation research have not been extended to the homeless. Recent studies including data from our research team show a considerable degree of readiness to quit smoking by homeless smokers and that nicotine replacement therapy (NRT) plus counseling show promise. However, homeless persons face many challenges that may constitute barriers for them to adhere to smoking cessation treatments even if such treatments have been proven effective in the general population. In order to reduce smoking-related health disparities within this underserved population, it is critical that cessation interventions including strategies to improve treatment adherence be developed to include homeless smokers. The primary aim of this study is to assess the effects of adherence-focused motivational interviewing (MI) to help homeless persons quit smoking.
Recruitment and retention will be enhanced by use of bus passes for transportation, debit cards, attractive intervention materials, collaboration with homeless shelters, and advice from a community advisory board. If successful, this study will provide a model for how to overcome barriers to cancer prevention services among homeless persons. It will also provide the impetus for policy changes directed at increasing homeless persons' access to smoking cessation pharmacotherapy and treatment.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55414
- University of Minnesota
-
-
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:
- currently homeless
- smoke 5 or more cigarettes per day
- smoked 100 cigarettes in lifetime
- aged 18 years or older
Exclusion Criteria:
- unstable mental illness
- pregnancy
- current history of psychoactive or alcohol dependence or psychotic disorder
- cognitive impairment
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: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 |
|---|---|
|
実験的:1
Participants will receive NRT and Motivational Interviewing counseling
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Motivational Interviewing; 8 weeks of counseling
他の名前:
|
|
アクティブコンパレータ:2
Varenicline plus brief advice
|
Brief advice, one time during initial session
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 |
時間枠 |
|---|---|
|
7-day point prevalence abstinence from smoking
時間枠:6 months after enrollment
|
6 months after enrollment
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Adherence to treatment
時間枠:12 weeks and 6 months after enrollment
|
12 weeks and 6 months after enrollment
|
|
Moderating effects of psychiatric co-morbidities and other substance abuse on treatment
時間枠:6 months after enrollment
|
6 months after enrollment
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Kolawole S Okuyemi, MD,MPH、University of Minnesota
出版物と役立つリンク
一般刊行物
- Ojo-Fati O, Joseph AM, Ig-Izevbekhai J, Thomas JL, Everson-Rose SA, Pratt R, Raymond N, Cooney NL, Luo X, Okuyemi KS. Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned. Trials. 2017 Jul 5;18(1):305. doi: 10.1186/s13063-017-2046-9.
- Ojo-Fati O, Thomas JL, Vogel RI, Ogedegbe O, Jean-Louis G, Okuyemi KS. Predictors of Adherence to Nicotine Replacement Therapy (Nicotine Patch) Among Homeless Persons Enrolled in a Randomized Controlled Trial Targeting Smoking Cessation. J Fam Med. 2016;3(7):1079. Epub 2016 Sep 6.
- Goldade K, Whembolua GL, Thomas J, Eischen S, Guo H, Connett J, Des Jarlais D, Resnicow K, Gelberg L, Owen G, Grant J, Ahluwalia JS, Okuyemi KS. Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomized clinical trial. Clin Trials. 2011 Dec;8(6):744-54. doi: 10.1177/1740774511423947.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
その他の研究ID番号
- 0708M14444
- HL081522
- NIH-522
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。