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

Last updated: October 10, 2024
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Harm-Reduction Counseling

E-cigarette (EC)

Ecological Momentary Intervention (EMI) Text Messaging

Clinical Study ID

NCT05815199
23-00124
  • Ages > 21
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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, Bipolardisorder, Depressive disorders, Trauma and stressor related disorders etc.) asdetermined 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

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 fornicotine use disorder and active mild alcohol or substance use disorders.

  • Past month suicidal ideation/suicide attempt and/or psychiatric hospitalization inthe last 30 days

Study Design

Total Participants: 60
Treatment Group(s): 4
Primary Treatment: Harm-Reduction Counseling
Phase:
Study Start date:
November 13, 2023
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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