Study Results
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View full resultsBasic Information
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COMPLETED
EARLY_PHASE1
99 participants
INTERVENTIONAL
2018-12-03
2020-04-06
Brief Summary
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Smoking use causes a number of deaths and diseases, including heart disease and cancer. All smokers are advised to quit. Varenicline (sometimes called Chantix), is a prescription medication approved by the US FDA. Many studies show that use of varenicline can help smokers quit smoking.
Varenicline is a prescription medication, which usually means that people have to see a doctor to get it. This study examines a different way to deliver varenicline, delivered directly to participants for a few weeks, and without need to see a doctor. This method is called "varenicline sampling."
The study is sponsored by the Hollings Cancer Center at the Medical University of South Carolina. The study is being done at the Medical University of South Carolina, but study recruitment is based state-wide, throughout South Carolina.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Varenicline Group
50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration.
Varenicline 0.5 MG
varenicline comes in bottles of 56 - 0.5 mg pills
Control Group
49 participants will be enrolled in this group.
No interventions assigned to this group
Interventions
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Varenicline 0.5 MG
varenicline comes in bottles of 56 - 0.5 mg pills
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* daily smoker (25+ days/previous month)
* smoking 5+ cigarettes/day;
* smoking \> 1yr;
* some interest in eventual quitting (\>2 on 10-point scale);
* has a primary care doctor and has seen that doctor at least once in past year; and
* own a smartphone or have regular (daily) access/use of email.
Exclusion Criteria
* suicidal ideation in past month;
* any lifetime suicide attempt;
* currently pregnant, breastfeeding, or planning to become pregnant; or
* reports of hallucinations.
18 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
Responsible Party
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Matthew Carpenter
Principal Investigator
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Carpenter MJ, Gray KM, Wahlquist AE, Cropsey K, Saladin ME, Froeliger B, Smith TT, Toll BA, Dahne J. A Pilot Randomized Clinical Trial of Remote Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation. Nicotine Tob Res. 2021 May 24;23(6):983-991. doi: 10.1093/ntr/ntaa241.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00078289
Identifier Type: -
Identifier Source: org_study_id