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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA296186-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This is randomized, placebo-controlled clinical trial in treatment-seeking adults who report regular e-cigarette use to test the hypothesis that varenicline is efficacious for quitting e-cigarettes.
Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) or matching placebo plus brief cessation advice from a counselor and self-management resources. All participants will also complete research assessments every 3 weeks during treatment and a final follow-up visit at week 26.
The primary objective is to test the efficacy of varenicline vs. placebo on e-cigarette quit rates. We will also evaluate predictors and moderators of outcomes and explore changes in health biomarkers following e-cigarette cessation treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Varenicline | Experimental | Participants will randomly be assigned to 12-weeks of varenicline (titrated to 2mg daily) plus brief cessation advice with a counselor and self-management resources. |
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| Placebo | Placebo Comparator | Participants will randomly be assigned to 12-weeks of matching placebo plus brief cessation advice with a counselor and self-management resources. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varenicline 1mg BID | Drug | 12 weeks following the standard titration of 1 mg, twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Abstinent From E-cigarette Use at Week 12 | 7-day point-prevalence e-cigarette abstinence (PPA) at Week 12 defined as no ecigarette use [and no use of any combusted tobacco product], not even a puff, biochemically verified by saliva cotinine | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Abstinent From E-cigarette Use at Week 26 | 7-day point-prevalence e-cigarette abstinence (PPA) at Week 26 defined as no ecigarette use [and no use of any combusted tobacco product], not even a puff, biochemically verified by saliva cotinine | Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Fucito, PhD | Contact | 2032001470 | lisa.fucito@yale.edu | |
| Michael Fatigate, PhD | Contact | Michael.fatigate@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Fucito, PhD | Yale University | Principal Investigator |
| Benjamin Toll, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center/Smilow Cancer Hospital at Yale-New Haven | Recruiting | New Haven | Connecticut | 06520 | United States |
Data will be shared to an NIH data repository - the NIMH Data Archive
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Access to the data is managed by the NIMH Data Archive
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Adults who report regular e-cigarette use
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| Placebo |
| Drug |
Matching placebo twice daily |
|
| Hollings Cancer Center at MUSC (HCC) | Recruiting | Charleston | South Carolina | 29425 | United States |
| D001523 |
| Mental Disorders |
| D011810 | Quinoxalines |