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The purpose of this study is to examine the feasibility of using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking outcomes. Participants will be randomized to receive either e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.
This pilot study will be a two-arm, randomized controlled trial. The investigator will randomize 40 participants into each intervention arm. Participants will be randomized to one of the two arms: e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges (0mg). Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. Participants will be asked to track their nicotine use via text message. All participants will receive a 20-30 minute behavioral counseling consultation with a trained tobacco counselor. Counselors will review each participant's smoking pattern and offer tailored behavioral and environmental change strategies including specific smoking reduction strategy options. Participants will be given a supply of e-cigarettes and followed for 3 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4.5% e-cig | Active Comparator | e-cigarettes with nicotine cartridges |
|
| 0 mg e-cig | Placebo Comparator | e-cigarettes with placebo cartridges (0mg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| e-cigarettes | Device | Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Number of Cigarettes Per Day (CPD) | Baseline up to 3 weeks | |
| Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks. | Using the percent difference in number of cigarettes per day from baseline to 3-weeks, the proportion of participants who reduced their cigarette usage per day by 50% or greater | up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants in Each Arm Who Reported Side Effects | Percentage of participants who responded yes to a yes/no question about experiencing any side effects | 3 weeks |
| Number of Participants Using Additional Tobacco Products and/or Marijuana |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donna Shelley, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 4.5% E-cig | e-cigarettes with nicotine cartridges e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. |
| FG001 | 0 mg E-cig | e-cigarettes with placebo cartridges (0mg). e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4.5% E-cig | e-cigarettes with nicotine cartridges e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in the Number of Cigarettes Per Day (CPD) | Posted | Mean | Standard Deviation | cigarettes per day (CPD) | Baseline up to 3 weeks |
|
3 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 4.5% E-cig | e-cigarettes with nicotine cartridges e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donna Shelley, MD MPH | NYU Langone Health | 917-494-4210 | donna.shelley@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2014 | Jul 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Up to 12 weeks |
| Percentage Satisfaction Rating for the E-cigarettes | Percent of participants who reported either "Strongly Agree" or "Agree" to liking using e-cigarettes at 3-weeks | 3 weeks |
| Number of Nicotine Urges/Cravings | Up to 12 weeks |
| Number of Participants Experiencing Withdrawal Symptoms | No data displayed because Outcome Measure has zero total participants analyzed. | Up to 12 weeks |
| 0 mg E-cig |
e-cigarettes with placebo cartridges (0mg). e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks. | Using the percent difference in number of cigarettes per day from baseline to 3-weeks, the proportion of participants who reduced their cigarette usage per day by 50% or greater | Posted | Number | proportion of participants | up to 3 weeks |
|
|
|
| Secondary | Percent of Participants in Each Arm Who Reported Side Effects | Percentage of participants who responded yes to a yes/no question about experiencing any side effects | Posted | Number | percentage of participants | 3 weeks |
|
|
|
| Secondary | Number of Participants Using Additional Tobacco Products and/or Marijuana | no data were collected for this Outcome Measure | Posted | Up to 12 weeks |
|
|
| Secondary | Percentage Satisfaction Rating for the E-cigarettes | Percent of participants who reported either "Strongly Agree" or "Agree" to liking using e-cigarettes at 3-weeks | Posted | Number | percentage of participants | 3 weeks |
|
|
|
| Secondary | Number of Nicotine Urges/Cravings | no data were collected for this Outcome Measure | Posted | Up to 12 weeks |
|
|
| Secondary | Number of Participants Experiencing Withdrawal Symptoms | No data displayed because Outcome Measure has zero total participants analyzed. | no data were collected for this Outcome Measure | Posted | Up to 12 weeks |
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 0 mg E-cig | e-cigarettes with placebo cartridges (0mg). e-cigarettes: Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. | 0 | 49 | 0 | 49 | 0 | 49 |
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