Assessing the Use of Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks.
研究概览
简要总结
The purpose of this study is to examine the feasibility of using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking outcomes. Participants will be randomized to receive either e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.
详细描述
This pilot study will be a two-arm, randomized controlled trial. The investigator will randomize 40 participants into each intervention arm. Participants will be randomized to one of the two arms: e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges (0mg). Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. Participants will be asked to track their nicotine use via text message. All participants will receive a 20-30 minute behavioral counseling consultation with a trained tobacco counselor. Counselors will review each participant's smoking pattern and offer tailored behavioral and environmental change strategies including specific smoking reduction strategy options. Participants will be given a supply of e-cigarettes and followed for 3 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-35 years old
- •daily smokers who smoke at least 10 cigarettes per day (CPD)
- •interested in reducing CPDs
- •able to provide consent
- •Use a cell phone and are willing/able to receive and respond to daily text messages regarding their cigarette use and e-cigarette use on their cell phone
- •Willing to use an e-cigarette for 3 weeks
排除标准
- •pregnant and/or breast feeding
- •currently using smoking cessation medications (including other forms of Nicotine Replacement Therapy (NRT), buproprion, or varenicline)
- •enrolled in a smoking cessation program or another cessation trial
- •have used an e-cigarette in the past 14 days
- •have used any other tobacco products (pipe, cigar, cigarillos, snuff, chewing tobacco, rolling tobacco, or hookah/shisha) in the past 30 days
- •score ≥7 (men) or ≥5 (women) on the Alcohol Use Disorders Identification Test (AUDIT-C),
- •score ≥ 5 on the Drug Abuse Screening Test-10 (DAST)
- •report having a history of asthma, other airways diseases, or heart disease.
研究组 & 干预措施
4.5% e-cig
e-cigarettes with nicotine cartridges
干预措施: e-cigarettes (Device)
0 mg e-cig
e-cigarettes with placebo cartridges (0mg).
干预措施: e-cigarettes (Device)
结局指标
主要结局
Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks.
时间窗: up to 3 weeks
Using the percent difference in number of cigarettes per day from baseline to 3-weeks, the proportion of participants who reduced their cigarette usage per day by 50% or greater
Changes in the Number of Cigarettes Per Day (CPD)
时间窗: Baseline up to 3 weeks
次要结局
- Number of Nicotine Urges/Cravings(Up to 12 weeks)
- Number of Participants Using Additional Tobacco Products and/or Marijuana(Up to 12 weeks)
- Number of Participants Experiencing Withdrawal Symptoms(Up to 12 weeks)
- Percent of Participants in Each Arm Who Reported Side Effects(3 weeks)
- Percentage Satisfaction Rating for the E-cigarettes(3 weeks)