Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

Assessing the Use of Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Tobacco Use Disorder
• Intervention / Treatment: Device: e-cigarettes

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 4.5% e-cig; e-cigarettes with nicotine cartridges	Device: 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: 0 mg e-cig; e-cigarettes with placebo cartridges (0mg).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Number of Cigarettes Per Day (CPD)		Baseline up to 3 weeks
Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 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	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants in Each Arm Who Reported Side Effects	Percentage of participants who responded yes to a yes/no question about experiencing any side effects	3 weeks
Number of Participants Using Additional Tobacco Products and/or Marijuana		Up to 12 weeks
Percentage Satisfaction Rating for the E-cigarettes	Percent of participants who reported either "Strongly Agree" or "Agree" to liking using e-cigarettes at 3-weeks	3 weeks
Number of Nicotine Urges/Cravings		Up to 12 weeks
Number of Participants Experiencing Withdrawal Symptoms	No data displayed because Outcome Measure has zero total participants analyzed.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Donna Shelley, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): March 26, 2018
• Study Completion (Actual): March 26, 2018

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (Estimate): December 11, 2015

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: smoking; cigarettes
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 14-01178

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes