Actively Recruiting
Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness
Led by NYU Langone Health · Updated on 2025-10-10
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating harm reduction strategies for adult smokers diagnosed with Serious Mental Illness (SMI) who use combustible cigarettes. The study compares the effects of e-cigarettes (EC) and nicotine replacement therapy (NRT) combined with harm-reduction counseling and Ecological Momentary Intervention (EMI) text messaging. The goal is to assess which approach better helps reduce cigarette smoking in this population. Participants are randomly assigned to one of two groups: one receives e-cigarettes along with nicotine patches and lozenges, while the other uses only nicotine replacement therapy products such as patches and lozenges. Both groups receive motivational counseling via telehealth sessions over an 8-week intervention period. Throughout this time, personalized text messages support behavior change as part of the EMI. During the study, participants are monitored for smoking reduction by checking the percentage who stop smoking cigarettes entirely by weeks 4 and 8, with additional follow-up at week 12. Assessments include self-reported changes in cigarette use and questionnaires measuring respiratory and mental health symptoms. The study tracks adherence to treatments and counseling, with data collected through electronic messages and regular evaluations. Participation continues until the last follow-up at 12 weeks.
CONDITIONS
Brief 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
- Diagnosis of serious mental illness such as schizophrenia, schizoaffective disorder, bipolar disorder, depressive disorders, or trauma and stressor related disorders
- Interested in reducing combustible cigarette smoking but not necessarily trying to quit
- Own a mobile phone or have regular access to one
- Able to provide an additional contact to improve follow-up rates
You will not qualify if you...
- Pregnant or breastfeeding
- Used tobacco other than combustible cigarettes in the past 2 weeks (e.g., e-cigarettes, cigarillos)
- Currently trying to quit combustible cigarettes
- Changed dose of psychotropic medications in the last 30 days
- Meets criteria for current alcohol or substance use disorder except nicotine use disorder or mild active alcohol or substance use disorders
- Had suicidal ideation, suicide attempt, or psychiatric hospitalization in the past 30 days
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 8 weeks
Participants receive either e-cigarettes or nicotine replacement therapy along with telehealth harm-reduction counseling and ecological momentary intervention text messaging over 8 weeks.
1 baseline visit and weekly telehealth counseling sessions during the 8 weeks
Duration - Up to 4 weeks after treatment (from Week 8 to Week 12)
Participants are monitored for changes in cigarette use and health outcomes up to 12 weeks from baseline.
Follow-up assessments at Week 12
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
I
Izamar Gallardo Castillo
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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