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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-cigarette (EC) | Other | Fixed dose. Participants are to use the EC as replacement for smoking combustible cigarettes. Participants will vape the EC. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to Week 12 |
| Self-Reported Percent Change in CPD from Baseline to Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omar El-Shahawy | Contact | 646-501-3587 | Omar.ElShahawy@nyulangone.org | |
| Izamar Gallardo Castillo | Contact | 646-501-3602 | Izamar.gallardocastillo@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Omar El-Shahawy | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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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Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D000072137 | Vaping |
| D040261 | Harm Reduction |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| D000095488 | Nicotine Replacement Therapy |
| C030340 | elastin microfibril interface located protein |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D004358 | Drug Therapy |
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| 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. |
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| Harm-Reduction Counseling | Behavioral | 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. |
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| Ecological Momentary Intervention (EMI) Text Messaging | Behavioral | 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. |
|
Measured via self-report (daily diary about smoking behavior). |
| Baseline, Week 8 |
| Self-Reported Percent Change in CPD from Baseline to Week 12 | Measured via self-report (daily diary about smoking behavior). | 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. | 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. | Baseline, Week 12 |
| D013812 | Therapeutics |