Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine e-cigarette.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine e-cigarette | Experimental | Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine. |
|
| Non-nicotine e-cigarette | Active Comparator | Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine e-cigarette | Other | Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in daily quantitative cigarette smoking | Quantitative tobacco cigarette smoking will be measured by experimenter-administered rating scale for 30 days prior to treatment through 6 month follow-up. | baseline, 8 weeks, and 6 months. |
| Change in exhaled carbon monoxide (CO) levels | Exhaled carbon monoxide levels will be measured with a precision instrument for detecting CO in exhaled breath. | baseline, 8 weeks, and 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term impact on lung function (spirometry) | Lung function will be measured by spirometry at time of study enrollment and at 6 months. | 6 months |
Not provided
Inclusion:
Exclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen R. Baldassarri, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital | New Haven | Connecticut | 06519 | United States |
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-nicotine e-cigarette | Other | Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine. |
|