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
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
November 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedOctober 10, 2025
October 1, 2025
2.3 years
April 4, 2023
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (\< 6 ppm).
Up to Week 4
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (\< 6 ppm).
Up to Week 8
Secondary Outcomes (5)
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12
Up to Week 12
Self-Reported Percent Change in CPD from Baseline to Week 8
Baseline, Week 8
Self-Reported Percent Change in CPD from Baseline to Week 12
Baseline, Week 12
Change in American Thoracic Questionnaire Score from Baseline to Week 12
Baseline, Week 12
Change in Symptom Check Questionnaire Score from Baseline to Week 12
Baseline, Week 12
Study Arms (2)
E-cigarettes (EC)
EXPERIMENTALAdult 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.
Nicotine Replacement Therapy (NRT)
ACTIVE COMPARATORAdult 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.
Interventions
Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar El-Shahawy
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2023
First Posted
April 18, 2023
Study Start
November 13, 2023
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data or researchers who provide a methodologically sound proposal will be granted access upon reasonable request or for individual participant data meta-analysis. Requests should be directed to Omar.ElShahawy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request or for individual participant data meta-analysis beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data or researcher who provides a methodologically sound proposal executes a data use agreement with NYU Langone Health. Requests may be directed to: Omar.ElShahawy@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.