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OpenTrials
Completed

NCT Number: NCT04063267

Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder

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.

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

E cigarettes

Other

Participants will be encouraged to substitute e-cigarettes for combustible cigarettes in order to reduce nicotine withdrawal symptoms

Nicotine Replacement Therapy

Other

Nicotine patches and gum to last them the first week based on their baseline recorded smoking. Participants will be advised to use both a 21 mg nicotine patch and 4 mg nicotine for cravings.

Primary outcomes

  1. Proportion of participants who achieve 50% reduction in CPD at 3 weeks.

    Time frame: 3 Weeks

    proportion of participants who achieve 50% reduction in CPD at 3 weeks.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2019
Registry last updated
Dec 20, 2024

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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