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E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness | Clinical Trials | Clareo Health

RECRUITINGNA

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

Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness

NCT05815199•NYU Langone Health

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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

Locations (1)

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

November 13, 2023

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

October 10, 2025

Enrollment

ESTIMATED participants

Conditions

Cigarette Smoking

Interventions

E-cigarette (EC)

OTHER

Nicotine Replacement Therapy (NRT)

OTHER

Harm-Reduction Counseling

BEHAVIORAL

Ecological Momentary Intervention (EMI) Text Messaging

BEHAVIORAL

Contacts

Omar El-Shahawy

CONTACT

646-501-3587 Omar.ElShahawy@nyulangone.org

Izamar Gallardo Castillo

CONTACT

646-501-3602 Izamar.gallardocastillo@nyulangone.org

Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers

NCT06372899

E-cigarette UseCigarette Smoking+2 more

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RECRUITINGNA

The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers

NCT06264154

SmokingTobacco Use+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Noncombustible Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers

The Role of Flavor in the Substitutability of E-cigarettes for Combustible Cigarettes Among Persistent Smokers

Studying Flavors and Cooling Agents in Oral Nicotine Pouches to Understand User Preferences

Carcinogen and Toxicant Exposure Among Young Adults Who Co-Use E-cigarettes and Cannabis (Co-Tox Study)

Beta-Adrenergic Modulation of Drug Cue Reactivity

Effect of Helpers Program On-line Training on Smoking Relapse and Social Networks