A Needs Survey of Urban Day Shelter Users and Preliminary Evaluation of Alternative Approaches to Combustible Cigarette Cessation: The Exchange Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Combustible Cigarette Cessation
研究概览
简要总结
This randomized controlled trial evaluated the feasibility and potential efficacy of 1) e-cigarette switching (EC) or 2) e-cigarette switching + financial incentives for combustible cigarette cessation (EC+FI)
详细描述
The current study examined the feasibility of e-cigarette switching and financial incentives contingent on combustible cigarette abstinence to promote combustible cigarette cessation among urban day shelter guests (N=60). A total of 60 adults who accessed the Homeless Alliance day shelter in Oklahoma City, OK were randomly assigned to 1 of 2 groups and followed weekly from 1 week prior to a scheduled EC switch date through 4 weeks post-switch date, with a final 8-week post-switch follow-up. The intervention groups were: 1) e-cigarette switching (EC) or 2) EC switching + small financial incentives for carbon monoxide (CO) verified combustible cigarette abstinence (FI + EC). The primary outcomes were self-reported combustible cigarette abstinence over the previous 7 days with carbon monoxide (CO)-verification at 4- and 8- weeks follow-up. Secondary outcomes included changes in CO from baseline, days of combustible cigarette smoking, and continued e-cigarette use. Other feasibility outcomes included study retention and perceptions of the intervention.
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
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥21 years of age
- •Expired CO level ≥8 ppm suggestive of current smoking
- •reported smoking ≥5 cigarettes per day
- •Willing and able to attend 8 study visits over a 10-week period
- •Interested in switching from CCs to ECs
- •Willing to abstain from smoking cannabis for the duration of the study
- •Able to speak and understand English
- •Demonstrated >6th grade English literacy by earning a score ≥4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form (REALM-SF),
- •Able to read a 3-sentence selection from the consent form
- •Not pregnant, breastfeeding, or planning to become pregnant.
排除标准
- 未提供
研究组 & 干预措施
E-Cigarette Switching (EC)
Participants were provided with an e-cigarette device and nicotine pods and advised to completely switch from combustible cigarettes to e-cigarettes. Although participants in the EC group did not earn incentives for combustible cigarette abstinence, they were yoked with a participant in the EC+FI group (described below), and they earned the same weekly incentive amount as their counterpart earned for combustible cigarette abstinence credited to a reloadable study credit card.
干预措施: E-cigarette Switching (Behavioral)
E-Cigarette Switching + Financial Incentives (EC+FI)
Participants assigned to the EC+FI group received ECs and pods and were instructed to switch from combustible cigarettes to e-cigarettes as described above for the EC group. Participants also earned escalating financial incentives for self-reported and carbon-monoxide-verified combustible cigarette abstinence via credits to a reloadable study credit card. Participants who reported combustible cigarette use and/or had a CO level >6 ppm did not earn incentives that week, but could earn incentives at the next visit with the incentive value reset to the starting value.
干预措施: E-cigarette Switching (Behavioral)
E-Cigarette Switching + Financial Incentives (EC+FI)
Participants assigned to the EC+FI group received ECs and pods and were instructed to switch from combustible cigarettes to e-cigarettes as described above for the EC group. Participants also earned escalating financial incentives for self-reported and carbon-monoxide-verified combustible cigarette abstinence via credits to a reloadable study credit card. Participants who reported combustible cigarette use and/or had a CO level >6 ppm did not earn incentives that week, but could earn incentives at the next visit with the incentive value reset to the starting value.
干预措施: Financial Incentives (Behavioral)
结局指标
主要结局
Combustible Cigarette Cessation
时间窗: 8 weeks post-quit/switch date
Self-reported and Carbon monoxide-verified (\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)
Combustible Cigarette Cessation
时间窗: 4 weeks post-switch date
Self-reported and Carbon monoxide-verified (\<=6 ppm) combustible cigarette smoking abstinence during the previous 7 days (missing = smoking)
次要结局
- Follow-Up Completion(8 weeks post-switch)
- Days of Combustible Cigarette Smoking, Past 7 Days(8 weeks post-switch)
- Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline(8 week post-switch)
- Days of E-cigarette Use, Past 7 Days(8 weeks post-switch)
- Combustible Cigarette Cessation (Complete Case Analysis)(8 weeks post-switch)
- Combustible Cigarette Cessation (Complete Case Analysis)(4 weeks post-switch)
- Expired Carbon Monoxide (CO), Parts Per Million (Ppm), Change From Baseline(4 weeks post-switch)
- Days of Combustible Cigarette Smoking, Past 7 Days(4 weeks post-switch)
- Days of E-cigarette Use, Past 7 Days(4 weeks post-switch)
- Follow-Up Completion(4 weeks post-switch)