RecruitingNot ApplicableNCT05815199

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

Sponsor

NYU Langone Health

Enrollment

60 participants

Start Date

Nov 13, 2023

Study Type

INTERVENTIONAL

Conditions

Cigarette Smoking

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.

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying E-cigarette (EC), a behavioral approach called Ecological Momentary Intervention (EMI) Text Messaging, and others for people with cigarette smoking. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERE-cigarette (EC)

Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.

OTHERNicotine Replacement Therapy (NRT)

Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.

BEHAVIORALHarm-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.

BEHAVIORALEcological 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.