RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: NYU Langone Health • ClinicalTrials.gov ID: NCT05815199

Registry updated: 2026-09-29

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Description

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.

Interventions

E-cigarette (EC) (Other)
Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
Nicotine Replacement Therapy (NRT) (Other)
Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.
Harm-Reduction Counseling (Behavioral)
At baseline, after randomization, participants will receive their first telehealth session (20\~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Up to five additional sessions will be delivered, 15\~20 minutes each.
Ecological Momentary Intervention (EMI) Text Messaging (Behavioral)
EMI can be defined as delivering tailored interventions via electronic messages (i.e., regular text messages) that include personalized feedback based on real-time assessment responses and other contextual factors. EMI will take place throughout the intervention period.

Eligibility criteria

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

Conditions

Cigarette Smoking

Locations

NYU Langone Health — New York, New York, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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