Electronic Cigarettes as a Harm Reduction Strategy Among People With Opioid Use Disorder on Buprenorphine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in cigarettes smoked per day
研究概览
简要总结
This project aims to investigate the impact of e-cigarette flavors and usage patterns on achieving harm-reduction milestones in a sample of cigarette smokers with opioid use disorder who are taking buprenorphine
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥21 years
- •Smoke ≥5 CPD for ≥1 year
- •Daily CC smoker
- •Willing to switch to EC
- •Exhaled CO ≥6 ppm
- •Diagnosed with OUD
- •Stable on bupropion treatment
- •In good physical and mental health
- •Able to use a smartphone
- •Willing to participate in all study components
- •Able to provide informed consent
排除标准
- •Interested in quitting CC (contemplation stage of change)
- •Use of EC on ≥4 of the past 30 days
- •Use of other tobacco products (e.g., cigars, smokeless tobacco) on ≥9 days of the past 30 days
- •Use of nicotine replacement therapy, smoking cessation medication, or a cessation attempt in the past 30 days
- •Hypertension
- •Medical condition that would contraindicate participation
- •Meet DSM-V criteria for major depressive episode, psychotic episode, or manic episode
- •Current suicidal ideation or suicide attempt in the past year
- •Psychiatric hospitalization in the past year
- •Contemplating pregnancy, currently pregnant, or breastfeeding
- •Unable to speak and/or read English
研究组 & 干预措施
Sweet-Cooling EC + Counseling
Those randomized to the intervention group will be provided a free 12-week supply of sweet-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.
干预措施: Brief individual counseling sessions (Behavioral)
Sweet non-cooling EC + Counseling
Those randomized to the intervention group will be provided a free 12-week supply of sweet non-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.
干预措施: Brief individual counseling sessions (Behavioral)
Tobacco-flavored EC + Counseling
Those randomized to the intervention group will be provided a free 12-week supply of tobacco-flavored electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC.
干预措施: Brief individual counseling sessions (Behavioral)
结局指标
主要结局
Change in cigarettes smoked per day
时间窗: Baseline to week 12
The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to weeks 12
次要结局
- Change in cigarettes smoked per day(Baseline to week 24)
- Switching(Weeks 12 and 24)
- Partial Switching(Weeks 12 and 24)
- Change in cigarettes smoked per day(Baseline to week 24)
- Percentage of participants with a ≥50% reduction in CPD(Baseline to weeks 12 and 26)
- Switching(Weeks 12 and 24)
- Partial Switching(Weeks 12 and 24)
- 7-Day CC Abstinence(Weeks 12 and 26)
- Change in carbon monoxide levels(Baselone to weeks 12 and 26)
研究者
Irene Pericot-Valverde
Assistant Professor
Clemson University