RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness

Quick Facts

Study Start:2023-11-13
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05815199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Currently smokes 5 or more CPD
  2. * Willingness and ability to provide informed consent
  3. * Age of at least 21 years
  4. * Has SMI diagnosis (such as Schizophrenia, Schizoaffective disorders, Bipolar disorder, Depressive disorders, Trauma and stressor related disorders etc.) as determined using the MINI tool
  5. * Interested in reducing CC smoking but not necessarily trying to quit
  6. * Own a mobile phone or have regular access to a mobile phone
  7. * Able to provide an additional contact to improve follow-up rates
  1. * Is pregnant or breastfeeding
  2. * Used tobacco other than CC in the past 2 weeks (e.g., EC, cigarillo)
  3. * Currently engaged in an attempt to quit CC
  4. * Change in dose of their psychotropic medication(s) in the last 30 days
  5. * Meeting DSM-V criteria for current alcohol or substance use disorder except for nicotine use disorder and active mild alcohol or substance use disorders.
  6. * Past month suicidal ideation/suicide attempt and/or psychiatric hospitalization in the last 30 days

Contacts and Locations

Study Contact

Omar El-Shahawy
CONTACT
646-501-3587
Omar.ElShahawy@nyulangone.org
Izamar Gallardo Castillo
CONTACT
646-501-3602
Izamar.gallardocastillo@nyulangone.org

Principal Investigator

Omar El-Shahawy
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Omar El-Shahawy, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-13
Study Completion Date2025-08

Study Record Updates

Study Start Date2023-11-13
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • E-cigarettes
  • Harm reduction
  • Cigarette smoking
  • Serious mental illness

Additional Relevant MeSH Terms

  • Cigarette Smoking