Longitudinal Care: Smoking Reduction to Aid Cessation
Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction
調査の概要
詳細な説明
Objective The objective of this project is to conduct a randomized controlled trial to compare 1) an extended quality care smoking cessation treatment delivered over a one-year period (EQC) to 2) quality care smoking cessation treatment delivered over an 8 week period (QC) to determine if EQC improves prolonged smoking abstinence.
Research Design/Methodology 500 smokers who are interested in quitting will be enrolled and randomly assigned to the EQC or QC groups. Both groups will initially receive a state-of-the-science smoking cessation intervention including behavioral and pharmacological components, delivered by a combination of in-person and telephone care. EQC participants who fail to quit, reduce but do not quit, or relapse will receive intensive treatment over the ensuing 12 months that encourages repeat quit attempts and smoking reduction if they are not to quit. We propose reduction as an intermediate goal in LC because this may increase the likelihood of cessation, increase self-efficacy and keep smokers and clinicians engaged. Reduction treatment will include behavioral treatment and nicotine replacement. QC participants will only receive occasional prompts to quit. The primary endpoint will be 6M of abstinence measured 18M after enrollment. Secondary endpoints will include point prevalent abstinence, smoking reduction, self-efficacy and satisfaction. We will also collect qualitative data from successful abstainers and reducers about decision making processes and intervention experiences.
Clinical Significance This project will address the potential role of smoking reduction in the treatment menu for smokers interested in quitting. This project examines mechanisms, methods and a "real world" application for reducing toxin exposure.
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
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55417
- Minneapolis VAMC
-
-
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 18-80
- Current and regular smoker 5 or more cigarettes per day
- Interested in making a quit attempt in the next 14 days
- Personal phone available
Exclusion Criteria:
- Pregnancy or plans to become pregnant in the next year
- Cannot speak English
- Not a union member or employee of specified worksite or immediate family member
- Member of household is currently enrolled in the study
- Not willing to comply with study protocol
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Longitudinal Care
One year of combined behavioral and pharamcological tobacco dependence treatment, with interim smoking reduciton for smokers who fail initial quit attempt.
|
This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups.
The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period.
This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt.
The UC group received evidence-based treatment that lasted 8 weeks.
|
|
アクティブコンパレータ:Usual Care
Evidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks
|
This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups.
The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period.
This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt.
The UC group received evidence-based treatment that lasted 8 weeks.
|
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 |
|---|---|---|
|
The primary endpoint will be 6M of abstinence measured 18M after enrollment.
時間枠:18M
|
6M prolonged abstinence
|
18M
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
7d point prevalent abstinence
時間枠:18M
|
Data collected at 21d, 3, 6, 12, 18M
|
18M
|
|
30d point prevalent abstinence
時間枠:18M
|
Data collected at 3, 6, 12, 18M
|
18M
|
|
Smoking reduction
時間枠:18M
|
Data collected at 3, 6, 12, 18M
|
18M
|
|
Total duration of abstinence
時間枠:18M
|
Time Line Follow Back
|
18M
|
協力者と研究者
捜査官
- 主任研究者:Anne M Joseph, MD, MPH、University of Minnesota
出版物と役立つリンク
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
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。