NCT05815199

E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness

Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cigarette Smoking

Interventions

Type	Name	Description
OTHER	E-cigarette (EC)	Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
OTHER	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.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2023-11-13
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-04-18
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States