RECRUITING

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

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.

Conditions

Cigarette Smoking
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Related Conditions:

Cigarette Smoking

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cigarette Smoking
Intervention / Treatment

-

Contacts and Locations

New York

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Omar El-Shahawy, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2025-08