跳至主要内容
临床试验/NCT04063267
NCT04063267已完成2 期

Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年10月27日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
48
试验地点
1
主要终点
Proportion of participants who achieve 50% reduction in CPD at 3 weeks.

研究概览

简要总结

Patients in addiction treatment have exceptionally higher rate of cigarette smoking and very low quit rates compared to the general population. 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 among patients in addiction treatment.

详细描述

Electronic nicotine delivery devices often referred to as e-cigarettes, are battery-powered devices that deliver vaporized nicotine when inhaled. Corresponding with the growth in media attention, marketing and promotion, awareness and use of e-cigarettes has increased dramatically. A large proportion of those using e-cigarettes use them to reduce the number of cigarettes they are smoking or to help them quit. Use of an e-cigarette by smokers unwilling or unable to stop smoking completely might be a good approach to reducing cigarette consumption as the e-cigarette imitates some behavioral aspects of cigarette smoking and contains nicotine. Moreover, the few existing studies on the effect of e-cigarettes on tobacco withdrawal and craving suggest promising potential to assist smokers in coping with smoking urges and decreasing cigarette use.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •smokes at least 10 cigarettes per day
  • •meet DSM-V AUD and/or OUD within the past year, interested in reducing CPDs
  • •able to provide consent
  • •use a cell phone, are willing/able to receive and respond to daily text messages regarding their cigarette use and e-cigarette use on their cell phone
  • •provide one additional contact, and are willing to use an e-cigarette for 3 weeks.

排除标准

  • •pregnant and/or breast feeding (self-reported)
  • •currently using smoking cessation medications (including other forms of NRT, buproprion, or varenicline)
  • •enrolled in a smoking cessation program or another cessation tria
  • •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
  • •report having a history of asthma, other airways diseases, or heart disease.

研究组 & 干预措施

E cigarettes

Experimental

干预措施: E cigarettes (Other)

Nicotine Replacement Therapy

Active Comparator

干预措施: Nicotine Replacement Therapy (Other)

结局指标

主要结局

Proportion of participants who achieve 50% reduction in CPD at 3 weeks.

时间窗: 3 Weeks

proportion of participants who achieve 50% reduction in CPD at 3 weeks.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Electronic Cigarettes as a Harm Reduction Strategy... | 临床试验