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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) versus telehealth motivational counseling with combination nicotine replacement therapy (NRT) + telehealth counseling on combustible cigarettes smoking reduction among persons with opioid use disorder (OUD) in methadone and buprenorphine treatment programs (opioid use disorder treatment programs (OUDTP)). OUDTP patients are a population with exceptionally high combustible cigarettes smoking burden and yet limited success in achieving meaningful clinical outcomes in tobacco treatment. If effective, electronic cigarettes would provide an additional tool for tobacco harm reduction among this difficult-to-treat vulnerable population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic Cigarette | Experimental | Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC). |
|
| Nicotine Replacement Therapy | Active Comparator | Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Motivational 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. Four additional sessions will be delivered (weeks 2, 3, 4, 6), 15~20 minutes each. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5) | Verified by exhaled carbon-monoxide (eCO) level. | Up to Visit 5 (Day 56) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up | Verified by exhaled carbon-monoxide (eCO) level. | Month 6 |
| Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omar El-Shahawy, MD, MPH, PhD | Contact | 646-501-3587 | Omar.ElShahawy@nyulangone.org | |
| Mohsen Abbasi, MD, MPH | Contact | 646-501-3581 | Mohsen.Abbasikangevari@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 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 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.
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 and researchers who provide a methodologically sound proposal will be granted access to the data upon reasonable request. 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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| Nicotine Replacement Product | Drug | Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions. |
|
| National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC). | Device | Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes. |
|
Verified by exhaled carbon-monoxide (eCO) level. |
| From Visit 5 (Day 56) up to Month 6 |
| Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5) | Verified by exhaled carbon-monoxide (eCO) level. | Baseline, Visit 5 (Day 56) |
| Change from Baseline in Self-Reported CPD at Month 6 | Verified by exhaled carbon-monoxide (eCO) level. | Baseline, Month 6 |
| Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5) | 8-item self assessment of participants' perceived physical and mental health over time. Each item lists a condition. For each item, participants indicate the number of days the condition applied to them. The total score is the average of responses and ranges from 0-30. Lower scores indicate greater perceived physical and mental health. A reduction in scores indicates perceived physical and mental health improved over the observational period. | Baseline, Visit 5 (Day 56) |
| Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up | 8-item self assessment of participants' perceived physical and mental health over time. Each item lists a condition. For each item, participants indicate the number of days the condition applied to them. The total score is the average of responses and ranges from 0-30. Lower scores indicate greater perceived physical and mental health. A reduction in scores indicates perceived physical and mental health improved over the observational period. | Baseline, Month 6 |
| Number of Respiratory Symptoms Reported at Baseline | Baseline |
| Number of Respiratory Symptoms Reported at End of Treatment (Visit 5) | Visit 5 (Day 56) |
| Number of Respiratory Symptoms Reported at Month 6 Follow-up | Month 6 |
| Albert Einstein College of Medicine | Not yet recruiting | The Bronx | New York | 10461 | United States |
|
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D000073865 | Cigarette Smoking |
| D012907 | Smoking |
| D000074264 | Smoking Reduction |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000073869 | Tobacco Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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