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

项目摘要/摘要 本申请是为回应特别利益通知(NOSI)而提出的，该通知被确认为非- CA-22-070：检查烟草和大麻使用模式的行政补充资料。这 补充申请将支持额外的数据收集，作为NCI资助的奖励的一部分(R37 CA237245，PI McClure，2019年7月1日至2024年6月30日)，题为“确定大麻使用和严重程度对烟草的影响” 戒烟结果：一项前瞻性的烟草治疗试验。获得资助的父母的总体目标R37优点 该奖项是进行一项前瞻性的烟草治疗研究，评估共同使用大麻对烟草的影响。 戒烟结果。NOSI NOT-CA-22-070是资助父母奖的理想选择，并将 允许通过突发的生态瞬间增加实时、生态有效的数据收集 对参加父母试验的参与者的大麻-烟草共同使用模式进行评估(EMA)。而当 家长研究正在收集关于大麻和烟草共同使用模式的每周数据，目前的措施可能是 不够敏感，不能将共同用户分类到使用模式的配置文件中，并在 特定使用事件。有关大麻和烟草共同使用的文献表明，有很大一部分仍是未知的。 关于共同使用的模式，共同使用的人之间的模式有何不同，以及共同使用模式可能 对健康和治疗结果产生不利影响。在整个过程中实时收集共同使用模式的数据 家长烟草治疗试验将提供关于共同使用模式的更准确和更精细的数据，以告知 这一领域的治疗影响和未来工作。对于为期一年的补习期，我们预计将有48人参加 大麻--烟草联合使用参与者参与额外的环境管理数据收集工作。EMA数据收集将是 在整个试验中分四次进行，以评估大麻和烟草在 参与者，以及这些模式在烟草治疗过程中如何变化。我们将进行为期一周的紧急救援行动 在试验期间的4个时间点收集数据：1)基线/用药前，2)1周(从目标戒烟开始 日期)，3)第11周(在第12周治疗结束访问结束，以及4)第25周(在最后第26周结束 后续访问)。通过进行多次EMA数据收集，我们将能够比较共同使用模式 在戒烟前阶段、治疗阶段和药物治疗后的随访阶段 被终止了。我们还将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，本附录将允许 吸烟者个体共用模式及其在烟草治疗过程中的变化探讨 共同使用大麻和烟草。这项关于烟草-大麻共同使用模式的额外数据收集将有助于 向文献提供信息，并为后续研究提供初步数据，重点是不同的共同使用和 它们对使用烟草和大麻产品的人的相关治疗影响。

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.