E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness
NCT ID: NCT05815199
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-11-13
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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E-cigarettes (EC)
Adult cigarette smokers with a SMI diagnosis randomized to the EC arm will receive NRT including nicotine patches and lozenges. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.
E-cigarette (EC)
Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
Harm-Reduction Counseling
At baseline, after randomization, participants will receive their first telehealth session (20\~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Up to five additional sessions will be delivered, 15\~20 minutes each.
Ecological Momentary Intervention (EMI) Text Messaging
EMI can be defined as delivering tailored interventions via electronic messages (i.e., regular text messages) that include personalized feedback based on real-time assessment responses and other contextual factors. EMI will take place throughout the intervention period.
Nicotine Replacement Therapy (NRT)
Adult cigarette smokers with a SMI diagnosis randomized to the NRT arm will receive NRT including nicotine patches and lozenges gum. Participants will also receive telehealth motivational counseling during the intervention period of 8 weeks.
Nicotine Replacement Therapy (NRT)
Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.
Harm-Reduction Counseling
At baseline, after randomization, participants will receive their first telehealth session (20\~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Up to five additional sessions will be delivered, 15\~20 minutes each.
Ecological Momentary Intervention (EMI) Text Messaging
EMI can be defined as delivering tailored interventions via electronic messages (i.e., regular text messages) that include personalized feedback based on real-time assessment responses and other contextual factors. EMI will take place throughout the intervention period.
Interventions
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E-cigarette (EC)
Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
Nicotine Replacement Therapy (NRT)
Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.
Harm-Reduction Counseling
At baseline, after randomization, participants will receive their first telehealth session (20\~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Up to five additional sessions will be delivered, 15\~20 minutes each.
Ecological Momentary Intervention (EMI) Text Messaging
EMI can be defined as delivering tailored interventions via electronic messages (i.e., regular text messages) that include personalized feedback based on real-time assessment responses and other contextual factors. EMI will take place throughout the intervention period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Omar El-Shahawy
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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23-00124
Identifier Type: -
Identifier Source: org_study_id
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