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NCT05815199NARecruiting

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

NYU Langone Health

Start Date

11/13/2023

Completion Date

3/1/2026

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 Criteria

Age Range: 21 years to No maximum

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

Interventions

OTHER

E-cigarette (EC)

OTHER

Nicotine Replacement Therapy (NRT)

BEHAVIORAL

Harm-Reduction Counseling

BEHAVIORAL

Ecological Momentary Intervention (EMI) Text Messaging

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Conditions

Cigarette Smoking

Locations

NYU Langone Health

New York, New York 10016

United States