Clinical trial NCT04063267: Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder
Official title: Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cigarette Smoking
Addiction
E Cig Use
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of participants who achieve 50% reduction in CPD at 3 weeks.
timeFrame: 3 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Scott Sherman, MD
role: PRINCIPAL_INVESTIGATOR
References: