E-cigarettes for Harm Reduction in Smokers with Serious Mental Illness

This study is testing if e-cigarettes (EC) or nicotine replacement therapy (NRT), like patches and lozenges, can help people with serious mental illness (SMI) reduce or stop smoking regular cigarettes. You would also receive counseling and text messages to help you. The study aims to see how many participants completely stop smoking cigarettes by 4 and 8 weeks. To join, you must be at least 21 years old, smoke 5 or more cigarettes daily, and have a diagnosis of SMI (such as schizophrenia, bipolar disorder, or depression). The current status of this study is unclear, and it plans to enroll 60 participants.

Study design
This is an open-label, randomized controlled trial. Participants will be assigned to one of two groups to compare e-cigarettes with nicotine replacement therapy.
What's involved
You will receive an initial telehealth counseling session, followed by up to five additional sessions. You will also receive text messages throughout the study period.
Compensation
Not stated in the trial record.
Follow-up
The study measures how well participants reduce smoking up to 8 weeks.

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NCT05815199

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

Recruiting
NAAges 21+InterventionalTreatment
NYU Langone Health
~60 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:E-cigarette (EC)Nicotine Replacement Therapy (NRT)Harm-Reduction CounselingEcological Momentary Intervention (EMI) Text Messaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4
Measured over Up to Week 4
+1 more outcome measured
Cigarette Smoking
1 sites across 1 states
New York1
  • Omar El-Shahawy · PRINCIPAL_INVESTIGATOR · NYU Langone Health

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Eligibility criteria

Inclusion

Currently smokes 5 or more CPD
Willingness and ability to provide informed consent
Age of at least 21 years
Has SMI diagnosis (such as Schizophrenia, Schizoaffective disorders, Bipolar disorder, Depressive disorders, Trauma and stressor related disorders etc.) as determined using the MINI tool
Interested in reducing CC smoking but not necessarily trying to quit
Own a mobile phone or have regular access to a mobile phone
Able to provide an additional contact to improve follow-up rates

Exclusion

Is pregnant or breastfeeding
Used tobacco other than CC in the past 2 weeks (e.g., EC, cigarillo)
Currently engaged in an attempt to quit CC
Change in dose of their psychotropic medication(s) in the last 30 days
Meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders.
Past month suicidal ideation/suicide attempt and/or psychiatric hospitalization in the last 30 days
  • Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4Up to Week 4

    Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (\< 6 ppm).

  • Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8Up to Week 8

    Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (\< 6 ppm).