「私のたばこをやめる道」
成人の禁煙を支援するための3つの多成分介入法の比較
The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults. The goal of this research proposal is to determine whether more intensive, culturally specific, evidence-based interventions are more effective at promoting long-term cessation and other key patient-centered outcomes compared to the usual evidence-based standard of care: services provided by a state-run quitline. This study compares the relative effectiveness of three different treatments (Standard, Intensive, and Intensive Incentivized) on long-term smoking cessation (biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day) among Black adults who smoke and want to quit.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Primary Objective: Identify the most effective treatment for increasing long-term smoking abstinence among Black adults who smoke.
Secondary Objectives:
- Compare the 3 interventions on key patient-relevant outcomes (e.g., treatment satisfaction, smoke fewer cigarettes per day, quality of life) using validated measures collected at 8 and 26 weeks post-target quit day (TQD)
- Identify subgroups for whom these treatments are especially effective or ineffective with respect to the primary and secondary outcomes.
- Compare indices of treatment engagement (e.g., percentage of counseling sessions attended, percentage of days used nicotine patch) among Black people who smoke and are randomly assigned to the 3 different treatment conditions.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 4
連絡先と場所
研究連絡先
研究連絡先
- 名前：Megan Piper, PhD
- 電話番号：608-265-5472
- メール：mep@ctri.wisc.edu
研究場所
-
-
Arizona
-
Phoenix、Arizona、アメリカ、85004
- まだ募集していません
- Arizona State University
-
-
Indiana
-
Indianapolis、Indiana、アメリカ、46202
- まだ募集していません
- Indiana University
-
-
Kansas
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Kansas City、Kansas、アメリカ、66160
- まだ募集していません
- University of Kansas Medical Center Research Institute, Inc
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-
Virginia
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Richmond、Virginia、アメリカ、23298
- まだ募集していません
- Virginia Commonwealth University
-
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Wisconsin
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Milwaukee、Wisconsin、アメリカ、53233
- 募集
- UW School of Medicine and Public Health
-
-
参加基準
適格基準
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:
- self-identify as Black
- smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days/week)
- motivated to quit smoking
- willing to discontinue any non-study smoking cessation pharmacotherapy use during study treatment.
Exclusion Criteria:
- currently taking bupropion for non-smoking cessation reasons
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
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ：Standard Intervention
The Standard Intervention will include 2 weeks of nicotine patches + 4 quitline-style counseling phone calls. |
Patch dosing will be consistent with the package insert
他の名前：
4, 10 to 15-minute counseling sessions (the duration of a typical quitline call) will occur via phone one week prior to the TQD, 1 day after the TQD, and 1 and 2 weeks after the TQD. |
|
実験的：Intensive Intervention
The Intensive Intervention will include 8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content. |
Patch dosing will be consistent with the package insert
他の名前：
Participants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions Pathways to Freedom video content, a 60-minute video that addresses key issues such as emotional dependence, nicotine replacement, identifying smoking triggers, developing coping skills, and other behavioral strategies people can use to support a quit attempt. |
|
実験的：Intensive Incentivized Intervention
The Intensive Incentivized Intervention will include all components provided in the Intensive intervention (8 weeks of nicotine patches (if eligible) + 8 counseling sessions (choice of individual phone or virtual group) + the Pathways to Freedom video content on the study website with additional smoking cessation content) and up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8) |
Patch dosing will be consistent with the package insert
他の名前：
Participants will have the option of choosing 8, 30-minute counseling phone calls or 8, 60-minute video group counseling sessions Pathways to Freedom video content, a 60-minute video that addresses key issues such as emotional dependence, nicotine replacement, identifying smoking triggers, developing coping skills, and other behavioral strategies people can use to support a quit attempt. up to $50 for completing counseling sessions ($5 for completing sessions 1-6 and $10 for completing sessions 7 and 8) |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day
時間枠：26 weeks post-TQD
|
The primary outcome for this study will be biochemically confirmed (anabasine less than 2 ng/ml) 7-day point-prevalence smoking abstinence at 26- weeks post-TQD |
26 weeks post-TQD
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
週あたりのたばこにかけるお金
時間枠：ベースライン、TQD後8週および26週
|
ベースライン、TQD後8週および26週
|
|
|
Biochemically confirmed abstinence from any nicotine product at 26-weeks post-target quit day
時間枠：26 weeks post-TQD
|
salivary cotinine using a cut-off of less than 10 ng/ml to indicate abstinence from any nicotine product (combusted cigarettes, e-cigarettes, nicotine replacement therapy [NRT]) |
26 weeks post-TQD
|
|
Treatment Satisfaction
時間枠：8 weeks post-TQD
|
Scored from 1 to 7 where higher scores indicate increased satisfaction with treatment. |
8 weeks post-TQD
|
|
Cigarettes per day
時間枠：baseline, 8 and 26 weeks post-TQD
|
Cigarettes per day based on the past 7 days. |
baseline, 8 and 26 weeks post-TQD
|
|
Quality of Life measured by the Medical Outcomes Study's 12-item Short Form Survey Instrument (SF-12)
時間枠：baseline, 8 and 26 weeks post-TQD
|
Scores range from 0 to 100 where higher scores indicate better quality of life. |
baseline, 8 and 26 weeks post-TQD
|
|
Smoking Cessation Self-efficacy using a single 10-point Likert scale
時間枠：baseline, 8 and 26 weeks post-TQD
|
Scores range from 1 to 10 where higher scores mean higher cessation self-efficacy. |
baseline, 8 and 26 weeks post-TQD
|
|
Psychological Distress measured by the 6-item Kessler screener (K6)
時間枠：baseline, 8 and 26 weeks post-TQD
|
Total range of scores is from 0-24 where higher scores mean decreased psychological distress. |
baseline, 8 and 26 weeks post-TQD
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Megan Piper, PhD、UW School of Medicine and Public Health
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- 2025-1697
- SMPH / CTRI (その他の識別子：UW Madison)
- BPS-2024C1-36762 (その他の助成金/資金番号：PCORI)
- Protocol Version 4/6/26 (その他の識別子：UW Madison)
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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。