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medication has not been available for the intervention
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Researchers are gathering information on the feasibility of treating e-cigarette users with 12-weeks of varenicline (Chantix®) in assisting with stopping the use of e-cigarettes.
Because the process of developing nicotine dependence and the reinforcing mechanisms of nicotine delivered in high concentrations are similar between tobacco cigarettes and newer generation electronic cigarettes, the investigators hypothesize that evidence based treatment approaches used in treating tobacco dependence should be effective in treating dependence on electronic cigarettes. Since there is no existing evidence base for treatment of electronic cigarette dependence, preliminary evidence is needed from feasibility and open label studies to guide in the development of future randomized clinical trials. In this study, vaping participants will be treated with a 12 week course of varenicline as well as have nicotine dependence counseling through a certified tobacco treatment specialist followed up 12 weeks post end of medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-cigarette users | Experimental | Participants who are regular users of e-cigarettes will be treated with a 12 week course of varenicline for stopping vaping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline | Drug | Dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 11 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of e-cigarette abstinence after 12 weeks of treatment with varenicline plus brief behavioral therapy as an aid to stop vaping | The rate of self reported e-cigarette abstinence verified biochemically with nicotine and nicotine metabolites in urine will be assessed at the end of a 12-week course of varenicline plus brief behavioral therapy. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Ebbert, MD | Mayo Clinic | Principal Investigator |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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12 weeks of varenicline
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|
| brief behavioral therapy | Other | brief behavioral therapy |
|
| D011810 | Quinoxalines |