Determining the impact of cannabis use and severity on tobacco cessation outcomes: A prospective tobacco treatment trial

确定大麻使用及其严重程度对戒烟结果的影响：前瞻性烟草治疗试验

• 批准号: 10629879
• 负责人: Erin A McClure
• 金额: $ 7.55万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10629879
• 关键词: Abstinence; Address; Administrative Supplement; Adult; Adverse effects; Affect; Age; Area; Award; Behavior Therapy; Biochemical; Cannabis; Counseling; Data; Data Collection; Dose; Ecological momentary assessment; Enrollment; Event; Follow-Up Studies; Funding; Future; General Population; Goals; Health; Individual; Individual Differences; Lead; Literature; Measures; Medical; Methodology; Methods; Nicotine Dependence; Outcome; Parents; Participant; Patient Self-Report; Pattern; Perception; Pharmaceutical Preparations; Pharmacotherapy; Phase; Positioning Attribute; Premedication; Prevalence; Prospective Studies; Recommendation; Research; Sampling Studies; Severities; Smoker; Statutes and Laws; Substance Use Disorder; Time; Tobacco; Tobacco Use Cessation; Tobacco Use Disorder; Tobacco use; Treatment outcome; United States; Variant; Visit; Work; cannabis cessation; clinical care; contingency management; diaries; efficacious treatment; follow-up; improved; interest; marijuana use; marijuana user; prospective; psychosocial; recruit; response; smoking cessation; substance use; therapy development; tobacco abstinence; tobacco cessation intervention; tobacco user; treatment comparison; treatment trial; varenicline

Project Summary/Abstract This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT- CA-22-070: Administrative Supplements for Examining Patterns of Tobacco and Cannabis Use. This supplement request will support additional data collection as part of the NCI-funded award (R37 CA237245, PI McClure, 07/01/2019-06/30/2024) entitled, “Determining the impact of cannabis use and severity on tobacco cessation outcomes: A prospective tobacco treatment trial.” The overall goal of the funded parent R37 MERIT award is to conduct a prospective tobacco treatment study evaluating the impact of cannabis co-use on tobacco cessation outcomes. The NOSI NOT-CA-22-070 supplement is an ideal fit for the funded parent award and will allow for the addition of real-time, ecologically valid data collection via bursts of ecological momentary assessment (EMA) on patterns of cannabis-tobacco co-use for participants enrolled in the parent trial. While the parent study is collecting weekly data on patterns of cannabis and tobacco co-use, current measures may be not be sensitive enough to categorize co-users into profiles of use patterns and determine relationships during specific use events. The literature on cannabis-tobacco co-use suggests that a great deal remains unknown regarding patterns of co-use, how patterns vary across those who co-use, and how co-use patterns may adversely impact health and treatment outcomes. Real-time data collection on co-use patterns throughout the parent tobacco treatment trial will provide more accurate and refined data on patterns of co-use to inform treatment implications and future work in this area. For the 1-year supplement, we anticipate enrolling 48 cannabis-tobacco co-use participants to engage in additional EMA data collection. EMA data collection will be conducted in four bursts across the trial to assess detailed patterns of cannabis-tobacco co-use among participants, and how those patterns change during tobacco treatment. We will conduct 1-week bursts of EMA data collection at 4 time points during the trial: 1) baseline/pre-medication, 2) Week 1 (starting at the target quit date), 3) Week 11 (ending at the Week 12 end-of-treatment visit, and 4) Week 25 (ending at the Week 26 final follow-up visit). By conducting multiple bursts of EMA data collection, we will be able to compare co-use patterns within an individual across the pre-quit phase, treatment phase and at follow-up after medication has been terminated. We will also be able to make comparisons in co-use patterns between participants to assess for varying patterns of co-use. Together with the original aims of the R37 award, this supplement will allow for the exploration of individual co-use patterns and changes in patterns during tobacco treatment among those who co-use cannabis and tobacco. This additional data collection on patterns of tobacco-cannabis co-use will help to inform the literature and provide preliminary data for follow-up studies focused on varying patterns of co-use and their associated treatment implications among those who use tobacco and cannabis products.

项目概要/摘要 本申请是为了响应被确定为 NOT- 的特殊利益通知 (NOSI) 而提交的 CA-22-070：检查烟草和大麻使用模式的行政补充。这 补充请求将支持额外的数据收集，作为 NCI 资助的奖项的一部分（R37 CA237245，PI McClure，07/01/2019-06/30/2024），题为“确定大麻使用及其严重程度对烟草的影响” 戒烟结果：前瞻性烟草治疗试验。”受资助母公司总体目标 R37 MERIT 奖项旨在进行一项前瞻性烟草治疗研究，评估大麻共同使用对烟草的影响 戒烟结果。 NOSI NOT-CA-22-070 补充品非常适合获得资助的家长奖，并将 允许通过生态瞬时突发添加实时、生态有效的数据收集 对参加家长试验的参与者的大麻与烟草共同使用模式进行评估（EMA）。虽然 家长研究正在每周收集有关大麻和烟草共同使用模式的数据，目前的措施可能是 不够敏感，无法将共同用户分类为使用模式档案并确定使用期间的关系 具体使用事件。关于大麻与烟草同时使用的文献表明，还有很多事情尚不清楚 关于共同使用模式，共同使用者之间的模式有何不同，以及共同使用模式如何可能 对健康和治疗结果产生不利影响。整个过程中共同使用模式的实时数据收集 父母烟草治疗试验将提供有关共同使用模式的更准确和更精细的数据，以告知 治疗影响和该领域的未来工作。对于 1 年期的补充，我们预计招收 48 名 大麻-烟草共同使用参与者参与额外的 EMA 数据收集。 EMA 数据收集将 整个试验分四次进行，以评估大麻与烟草同时使用的详细模式 参与者，以及这些模式在烟草治疗期间如何变化。我们将进行为期 1 周的 EMA 爆发 试验期间 4 个时间点的数据收集：1) 基线/用药前，2) 第 1 周（从目标戒烟开始） 日期），3）第 11 周（在第 12 周治疗结束访视时结束，以及 4）第 25 周（在第 26 周最后一次访视时结束） 后续回访）。通过进行多次 EMA 数据收集，我们将能够比较共同使用模式 个体在戒烟前阶段、治疗阶段以及药物治疗后的随访期间 终止。我们还能够比较参与者之间的共同使用模式，以评估 不同的共同使用模式。与 R37 奖项的最初目标一起，该补充将允许 探索烟草治疗期间个体共同使用模式和模式变化 共同使用大麻和烟草。关于烟草与大麻共同使用模式的额外数据收集将有助于 为关注不同共同使用模式的后续研究提供文献资料并提供初步数据 它们对使用烟草和大麻产品的人的相关治疗影响。