Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT05815199

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

Led by NYU Langone Health · Updated on 2025-10-10

60

Participants Needed

1

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Currently smokes 5 or more combustible cigarettes per day
  • Willingness and ability to provide informed consent
  • Age of at least 21 years
  • Diagnosed with Serious Mental Illness (SMI) such as schizophrenia, schizoaffective disorder, bipolar disorder, depressive disorders, or trauma-related disorders
  • Interested in reducing combustible cigarette smoking but not necessarily trying to quit
  • Owns or has regular access to a mobile phone
  • Able to provide an additional contact to help with follow-up
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Used tobacco products other than combustible cigarettes in the past 2 weeks (e.g., e-cigarettes, cigarillos)
  • Currently attempting to quit combustible cigarettes
  • Changed dose of psychotropic medications in the last 30 days
  • Meets DSM-V criteria for current alcohol or substance use disorder except nicotine use disorder and mild active alcohol or substance use disorders
  • Had suicidal thoughts, suicide attempt, or psychiatric hospitalization in the past 30 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

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Research Team

O

Omar El-Shahawy

CONTACT

I

Izamar Gallardo Castillo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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