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Search / Trial NCT05815199

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

Launched by NYU LANGONE HEALTH · Apr 4, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

E Cigarettes Harm Reduction Cigarette Smoking Serious Mental Illness

ClinConnect Summary

This clinical trial is looking at how e-cigarettes can help people with serious mental illnesses who smoke regular cigarettes reduce their smoking. The study will involve participants who currently smoke at least five cigarettes a day and are diagnosed with conditions like schizophrenia or bipolar disorder. These participants will receive support through counseling and text messages to help them, and they will be randomly divided into two groups. One group will use e-cigarettes, while the other will use nicotine replacement therapies, like patches or lozenges, to see which method is more effective in helping them cut back on smoking.

To be eligible for the trial, participants should be at least 21 years old, own or have access to a mobile phone, and be willing to provide contact information for follow-up. They shouldn't be pregnant, have recently used other tobacco products, or be actively trying to quit smoking. Overall, participants can expect to receive guidance and support as they try to reduce their cigarette smoking, while also contributing to valuable research that may help others in similar situations.

Gender

ALL

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

About Nyu Langone Health

NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.

Locations

New York, New York, United States

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Omar El-Shahawy

Principal Investigator

NYU Langone Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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