Using e-cigarettes to help smokers with serious mental illness reduce smoking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized controlled trial aims to evaluate the effectiveness of e-cigarettes compared to nicotine replacement therapy in reducing combustible cigarette smoking among individuals diagnosed with serious mental illness. Participants will receive harm-reduction counseling and Ecological Momentary Intervention text messaging to support their smoking reduction efforts. The study will involve individuals who smoke at least five cigarettes per day and are interested in reducing their smoking without necessarily quitting completely. The trial will assess the impact of these interventions on smoking behavior over a specified period.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Omar El-Shahawy — NYU Langone Health
• Study coordinator: Omar El-Shahawy
• Email: Omar.ElShahawy@nyulangone.org
• Phone: 646-501-3587

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.