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Hollings Cancer Center Varenicline Sampling Study

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ClinicalTrials.gov Identifier: NCT03742154
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew Carpenter, Medical University of South Carolina

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
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)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking

Arm Intervention/treatment
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
Other Names:
  • Chantix
  • Varenicline Pill

No Intervention: Control Group
40 participants will be enrolled in this group.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Conversion of varenicline use [ Time Frame: At the end of the three-month follow up ]
    % of participants using varenicline at 3-month follow up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18+
  • 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:

  • reports of history of seizures or seizure disorders;
  • suicidal ideation in past month;
  • any lifetime suicide attempt;
  • currently pregnant, breastfeeding, or planning to become pregnant; or
  • reports of hallucinations.

Information from the National Library of Medicine

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


Contacts
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Contact: Lisa L Coles 843-876-2291 colesl@musc.edu
Contact: Amy Boatright 843-876-2440 boatrigh@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Lisa Coles         
Sponsors and Collaborators
Medical University of South Carolina

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Responsible Party: Matthew Carpenter, Principal Investigator, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03742154     History of Changes
Other Study ID Numbers: Pro00078289
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs