N/A
N=100
Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy
Tobacco Use Disorder · Smoking
Bottom Line
View on ClinicalTrials.gov: NCT02628964 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Changes in the Number of Cigarettes Per Day (CPD) — 8.2; 7.3 cigarettes per day (CPD)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- e-cigarettes (Device)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Number of Cigarettes Per Day (CPD) |
8.2; 7.3 | — |
| PRIMARY Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks. |
.7; .49 | — |
| SECONDARY Percent of Participants in Each Arm Who Reported Side Effects |
22.5; 10.5 | — |
| SECONDARY Number of Participants Using Additional Tobacco Products and/or Marijuana |
— | — |
| SECONDARY Percentage Satisfaction Rating for the E-cigarettes |
65; 71.8 | — |
| SECONDARY Number of Nicotine Urges/Cravings |
— | — |
| SECONDARY Number of Participants Experiencing Withdrawal Symptoms |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02628964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.