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E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness
Sponsor: NYU Langone Health
Summary
In this open-label, randomized controlled trial study, participants who smoke combustible cigarettes (CC) and are diagnosed with Serious Mental Illness (SMI) will be randomized in two arms to receive harm-reduction counseling and Ecological Momentary Intervention text messaging (EMI) along with either e-cigarettes (EC) or nicotine replacement therapy (NRT) such as patch and lozenges to compare the efficacy in CC smoking reduction.
Official title: Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-11-13
Completion Date
2026-03
Last Updated
2025-10-10
Healthy Volunteers
No
Conditions
Interventions
E-cigarette (EC)
Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
Nicotine Replacement Therapy (NRT)
Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.
Harm-Reduction Counseling
At baseline, after randomization, participants will receive their first telehealth session (20\~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Up to five additional sessions will be delivered, 15\~20 minutes each.
Ecological Momentary Intervention (EMI) Text Messaging
EMI can be defined as delivering tailored interventions via electronic messages (i.e., regular text messages) that include personalized feedback based on real-time assessment responses and other contextual factors. EMI will take place throughout the intervention period.
Locations (1)
NYU Langone Health
New York, New York, United States