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

NCT05815199 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Omar El-Shahawy · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-13
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05815199 on ClinicalTrials.gov