Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
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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