Hollings Cancer Center Varenicline Sampling Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03742154|
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : December 21, 2018
The purpose of this study is to learn what happens when people are given a free, 4-week, sample of varenicline, a smoking cessation medication. Investigators will look at quit attempts, changes in smoking, and attitude towards varenicline, in both smokers who want to quit and those who do not.
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Smoking Cessation Smoking, Tobacco Smoking, Cigarette||Drug: Varenicline 0.5 MG||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized into one of the two study groups, like drawing numbers from a hat. One group will receive a mailed sample of varenicline, and the other will not. Participants have 50/50 chance of being in either group. Both groups will contain equal numbers of smokers motivated to quit and smokers not currently motivated to quit.|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation|
|Actual Study Start Date :||December 3, 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Varenicline Group
40 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.
Drug: Varenicline 0.5 MG
varenicline comes in bottles of 56 - 0.5 mg pills
No Intervention: Control Group
40 participants will be enrolled in this group.
- Quit Attempts [ Time Frame: From study enrollment through end of three-month follow up ]% of participants with any self-defined and any self-defined 24hr quit attempt
- Conversion of varenicline use [ Time Frame: At the end of the three-month follow up ]% of participants using varenicline at 3-month follow up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742154
|Contact: Lisa L Colesfirstname.lastname@example.org|
|Contact: Amy Boatrightemail@example.com|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Lisa Coles|