RITCH: Reducing Disparities in Tobacco Cessation Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Latency to Relapse
研究概览
简要总结
Tobacco use is a leading contributor to racial and socioeconomic health disparities in the US primarily due to an unequal burden of tobacco-related disease from a disproportionate share of smokers in African American and lower socioeconomic (SES) groups. Unlike many other health risk behaviors, tobacco-related health disparities are increasing despite a large treatment network of free telephone and in-person counseling services, perhaps due to significant disparities in treatment outcomes. The goal of this project is to revise the standard treatment for tobacco dependence to address key factors associated with treatment outcome disparities and more fully meet the needs of lower SES and African American smokers thereby reducing socioeconomic disparities in tobacco dependence treatment outcomes, halting the alarming increase in tobacco-related health disparities, and reducing a leading cause of racial and socioeconomic health disparities in the US.
详细描述
This study will be conducted in five phases. Each phase utilizes the results from the previous phase. Each phase is also associated with at least one specific aim.
Phase One (Aim One): Complete a revised version of a standard, widely utilized, multi-component, cognitive-behavior treatment manual for tobacco dependence to include commonly utilized, cognitive-behavioral interventions that specifically address the key factors associated with treatment outcome disparities.
Phase Two (Aim Two): Using the PEN-3 Model,1-3 target and tailor RITCh_1 to address the needs of smokers who are of lower SES as well as smokers who are minority, particularly African American. In this preparatory activity, the research team will tailor and target RITCh_1 using this well-accepted theoretical model and produce the second draft of the revised treatment, called RITCh_2. Human subjects are not involved with this phase of the research. No data will be collected.
Phase Three (Aim Three): Pilot test RITCh_2 with three treatment groups (5-10 participants per group) to assess understandability and acceptability and to ensure that it can be delivered in the same 60-minute per session time frame as the standard treatment. This is a qualitative study in which the investigators will pilot test RITCh_2 with 21 participants who will be consented as pilot study participants. See Pilot Study Informed Consent Form. Contact and demographic information will be collected from participants, but not baseline and outcome assessments. Participant feedback will be provided in a group format and will not be linked to identifying information. The research team will incorporate participant feedback into a third draft of the revised treatment, RITCh_3.
Phase Four (Aim Four): Compare the effects of SES on treatment outcomes in a socioeconomically and racially diverse group of participants treated with RITCh_3 and the standard treatment. The investigators will conduct a randomized controlled trial (n=253) comparing the efficacy of RITCh_3 to the standard treatment. Investigators will use a randomized treatment design and two methods for assessing abstinence (latency to relapse and six-month point prevalence abstinence rates) to compare the effects of SES and treatment condition on treatment outcomes. Investigators expect RITCh_3 to demonstrate fewer treatment outcome disparities than standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •smoking cigarettes daily
- •expressing a desire to quit smoking in the next 30 days
- •no regular use of other tobacco products
- •age 18 years or older
- •no plans to move from the area in the next six months
- •willing to comply with treatment
- •able to engage in treatment
排除标准
- •any contra-indication for use of the nicotine patch (i.e., uncontrolled high blood pressure, allergic reaction to patch adhesive, pregnancy, etc.),
- •currently using mediations for smoking cessation (bupropion, varenicline, or any form of NRT)
- •drinking more than 20 alcoholic drinks per week
- •positive test on a urine screen for drugs of abuse at baseline (amphetamine, methamphetamine, cannabis, cocaine, opioids, methadone, etc.)
- •current diagnosis that would prohibit engagement in brief CBT (active psychotic disorder, acute major depressive episode, significantly cognitively impaired)
- •current regular use of other forms of tobacco other than smoking cigarettes
结局指标
主要结局
Latency to Relapse
时间窗: 6 months following scheduled week 3 quit date
Abstinence will be assessed with latency to relapse (days from Quit Date to relapse or 7 consecutive days of smoking after a 24 hour quit attempt)
次要结局
未报告次要终点
研究者
Christine Sheffer
Associate Professor
The City College of New York