Overview

This trial is active, not recruiting.

Conditions tobacco use disorder, smoking
Treatment e-cigarettes
Sponsor New York University School of Medicine
Start date May 2015
End date March 2017
Trial size 100 participants
Trial identifier NCT02628964, 14-01178

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Active Comparator)
e-cigarettes with nicotine cartridges
e-cigarettes
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.
(Placebo Comparator)
e-cigarettes with placebo cartridges (0mg).
e-cigarettes
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.

Primary Outcomes

Measure
Changes in the number of cigarettes per day (CPD)
time frame: up to 3 weeks
Proportion of participants who achieve 50% reduction in number of cigarettes per day at 3 weeks.
time frame: up to 3 weeks

Secondary Outcomes

Measure
Number of side effects associated with e-cigarette use
time frame: Up to 12 weeks
Number of participants using additional tobacco products and/or marijuana
time frame: Up to 12 weeks
Satisfaction rating for the e-cigarettes
time frame: Up to 12 weeks
Number of nicotine urges/cravings
time frame: Up to 12 weeks
Number of participants experiencing withdrawal symptoms
time frame: Up to 12 weeks

Eligibility Criteria

Male or female participants from 21 years up to 35 years old.

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.

Additional Information

Official title Assessing the Use of Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy
Principal investigator Donna Shelley, MD
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.