Cigarette SmokingNCT05815199
E-cigarettes for Harm Reduction Among Smokers With Serious Mental Illness
A study testing E-cigarette (EC), Nicotine Replacement Therapy (NRT) and Harm-Reduction Counseling in people with Cigarette Smoking, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- E-cigarette (EC), Nicotine Replacement Therapy (NRT) and Harm-Reduction Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness
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
- Being tested
- E-cigarette (EC), Nicotine Replacement Therapy (NRT), Harm-Reduction Counseling, Ecological Momentary Intervention (EMI) Text Messaging
- Keywords
- E-cigarettes, Harm reduction, Cigarette smoking, Serious mental illness
- Medical subject headings
- Cigarette Smoking, Vaping, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigarette (EC)Other
Also called NJOY Ace or NJOY Daily Electronic Cigarette
Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC.
Nicotine Replacement Therapy (NRT)Other
Includes nicotine patches and lozenges. NRT use recommendations will follow the guidelines of the product, e.g. one patch per day.
Harm-Reduction CounselingBehavioural
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 MessagingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| E-cigarettes (EC) | Experimental | 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. Receives: Other: E-cigarette (EC); Behavioral: Harm-Reduction Counseling; Behavioral: Ecological Momentary Intervention (EMI) Text Messaging |
| Nicotine Replacement Therapy (NRT) | Active comparator | 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. Receives: Other: Nicotine Replacement Therapy (NRT); Behavioral: Harm-Reduction Counseling; Behavioral: Ecological Momentary Intervention (EMI) Text Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Up to Week 8
Secondary outcomes (5)
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
Measured: Up to Week 12
Self-Reported Percent Change in CPD from Baseline to Week 8
Measured via self-report (daily diary about smoking behavior).
Measured: Baseline, Week 8
Self-Reported Percent Change in CPD from Baseline to Week 12
Measured via self-report (daily diary about smoking behavior).
Measured: Baseline, Week 12
Change in American Thoracic Questionnaire Score from Baseline to Week 12
8-item questionnaire assessing general thoracic pain. Items are rated on a Likert scale from 1 (never) to 5 (every day). The total score is the sum of responses and ranges from 8-40; higher scores indicate more severe impact of general thoracic pain.
Measured: Baseline, Week 12
Change in Symptom Check Questionnaire Score from Baseline to Week 12
9-item assessment of chronic obstructive pulmonary disease (COPD) symptoms. Each item is marked as either "yes" or "no." The total score is the number of "yes" responses and ranges from 0-9; higher scores indicate more severe COPD symptoms.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start13 Nov 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar El-Shahawy, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815199
- Sponsor's protocol ID
- 23-00124
- Status last verified
- Sep 2026
- First submitted
- 4 Apr 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Impact of Counseling Enhanced Using Electronic Cigarettes for Harm Reduction in People With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT05815199
- Acronym / sponsor ID
- 23-00124
- Conditions
- Cigarette Smoking
- Keywords
- E-cigarettes, Harm reduction, Cigarette smoking, Serious mental illness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-cigarettes (EC) | Experimental | Other: E-cigarette (EC), Behavioral: Harm-Reduction Counseling, Behavioral: Ecological Momentary Intervention (EMI) Text MessagingAdult 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 comparator | Other: Nicotine Replacement Therapy (NRT), Behavioral: Harm-Reduction Counseling, Behavioral: Ecological Momentary Intervention (EMI) Text MessagingAdult 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-cigarette (EC)Also: NJOY Ace or NJOY Daily Electronic CigaretteFixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC. | Other | E-cigarettes (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. | Other | Nicotine Replacement Therapy (NRT) |
| Harm-Reduction CounselingAt 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. | Behavioural | E-cigarettes (EC), Nicotine Replacement Therapy (NRT) |
| Ecological Momentary Intervention (EMI) Text MessagingEMI 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. | Behavioural | E-cigarettes (EC), Nicotine Replacement Therapy (NRT) |
Primary outcome
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4
Time frame: Up to Week 4
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 8
Time frame: Up to Week 8
Measured via self-report (daily diary about smoking behavior) and verified by exhaled carbon-monoxide (eCO) level (< 6 ppm).
5 secondary outcomes
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 12
Time frame: Up to Week 12
Self-Reported Percent Change in CPD from Baseline to Week 8
Time frame: Baseline, Week 8
Self-Reported Percent Change in CPD from Baseline to Week 12
Time frame: Baseline, Week 12
Change in American Thoracic Questionnaire Score from Baseline to Week 12
Time frame: Baseline, Week 12
Change in Symptom Check Questionnaire Score from Baseline to Week 12
Time frame: Baseline, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar El-Shahawy principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette (EC), Nicotine Replacement Therapy (NRT) and Harm-Reduction Counseling in people with Cigarette Smoking, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar El-Shahawy (646-501-3587, Omar.ElShahawy@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Achieve a 100% Reduction in Cigarettes Per Day (CPD) by Week 4 (time frame: Up to Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.