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Completed

NCT Number: NCT02628964

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.

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Mental Disorders Smoking Substance-Related Disorders

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

e-cigarettes

Device

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

  1. Changes in the Number of Cigarettes Per Day (CPD)

    Time frame: Baseline up to 3 weeks

  2. Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks.

    Time frame: up to 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

Secondary outcomes

  1. Percent of Participants in Each Arm Who Reported Side Effects

    Time frame: 3 weeks

    Percentage of participants who responded yes to a yes/no question about experiencing any side effects

  2. Number of Participants Using Additional Tobacco Products and/or Marijuana

    Time frame: Up to 12 weeks

  3. Percentage Satisfaction Rating for the E-cigarettes

    Time frame: 3 weeks

    Percent of participants who reported either "Strongly Agree" or "Agree" to liking using e-cigarettes at 3-weeks

  4. Number of Nicotine Urges/Cravings

    Time frame: Up to 12 weeks

  5. Number of Participants Experiencing Withdrawal Symptoms

    Time frame: Up to 12 weeks

    No data displayed because Outcome Measure has zero total participants analyzed.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2015
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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