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
- Cigarette Smoking
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- NYU Langone Health
- Enrolment target
- 60
- Started
- 13 November 2023
- Main results due
- March 2027
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Aged 21 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
NYU Langone Health
New York, New York, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05815199. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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