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. 2021 Sep 14;2021(9):CD010216. doi: 10.1002/14651858.CD010216.pub6

NCT04063267.

Study name Electronic cigarettes as a harm reduction strategy in individuals with substance use disorder
Methods Parallel, randomized trial
Recruitment/Setting: Not specified
Participants Estimated enrolment: 240
Inclusion criteria:
  • Smokes at least 10 cpd

  • Meet DSM‐V AUD and/or OUD within the past year, interested in reducing cpd

  • Able to provide consent

  • Use a cell phone, are willing/able to receive and respond to daily text messages about their cigarette use and e‐cigarette use on their cell phone

  • Provide 1 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, bupropion, 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

  • Report having a history of asthma, other airways diseases, or heart disease

Interventions E‐cigarettes arm:
  • Participants will be encouraged to substitute e‐cigarettes for combustible cigarettes in order to reduce nicotine withdrawal symptoms


Nicotine Replacement Therapy arm:
  • 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

Outcomes Proportion of participants who achieve 50% reduction in cpd at 3 weeks
Starting date 15 September 2019
Contact information NYU Langone Health, Scott.Sherman@nyulangone.org
Notes