E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness
Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness
Who can join
Ages 21 and older · All sexes
Full 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 the study
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.
What is being tested
- E-cigarette (EC) (other)
- Nicotine Replacement Therapy (NRT) (other)
- Harm-Reduction Counseling (behavioral)
- Ecological Momentary Intervention (EMI) Text Messaging (behavioral)
Sponsor: NYU Langone Health · Participants: 60 · Started: Nov 13, 2023
Contact the study team
- Omar El-Shahawy · Phone: 646-501-3587
- Noah Shedivy · Phone: 507-424-9415
Official record on ClinicalTrials.gov — NCT05815199
Locations in the U.S.
| New York | NYU Langone Health, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.