Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA056445-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.
Even though e-cigarettes have risen in prevalence over the last decade, data on the use of these products as harm reduction tools for smokers who try to switch completely is lacking.
These data are urgently needed for several reasons.
The reviews underscore the need for additional data on this topic, especially data comparing the products to pharmacotherapy. The goal of the proposed study is to provide one of the first well-designed randomized controlled trials that addresses whether alternative tobacco products (e-cigarettes) have the potential to serve as harm reduction tools in a critical population-smokers who have tried to quit smoking using FDA-approved pharmacotherapy and failed to do so.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choice of Medication | Experimental | This arm includes participants randomly assigned to the Meds Group. Participants will choose between 1) combo NRT and 2) varenicline. The NRT will consist of transdermal NRT and nicotine lozenge. Participants will receive study product for 11 weeks. |
|
| Choice of E-Cigarette | Experimental | This arm includes participants randomly assigned to the E-Cigarette Group. Participants will choose between two different brands of e-cigarettes and choose up to two different flavors. Participants will receive study product for 11 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switching to E-Cigarette | Behavioral | Participants will receive eleven weeks of e-cigarette products with instructions to switch completely at switch date |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback | Self-reported zero cigarettes in the past 7 days on timeline followback at Week 11 + expired carbon monoxide < 6 ppm | 11 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Greater than 50% reduction in cigarette smoking | Average reduction in the number of cigarettes smoked per day on 7-day timeline followback at Week 11 of at least 50% or greater compared to average baseline number of cigarettes smoked per day on 7 day timeline followback | 11 Weeks |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracy Smith, PhD | Contact | (843)-792-5164 | smithtra@musc.edu | |
| Merritt McDonald | Contact | (843)-876-2430 | mcdoname@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tracy Smith | smithtra@musc.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Univeristy of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
Not provided
| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Switching using Medication | Behavioral | Participants will receive eleven weeks of FDA approved medication, either varenicline or combination NRT, with instructions to quit smoking cigarettes at quit date |
|