NCT04063267.

Study name	Electronic cigarettes as a harm reduction strategy in individuals with substance use disorder
Methods	Parallel‐group, 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 breastfeeding (self‐reported) Currently using smoking cessation medications (including other forms of NRT, bupropion, or varenicline) Enrolled in a smoking cessation programme 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
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