Hollings Cancer Center Varenicline Sampling Study

Early Phase 1

Completed

• Conditions: Smoking Cessation; Smoking, Cigarette; Smoking; Smoking, Tobacco
• Interventions: Drug: Varenicline 0.5 MG

• Registration Number: NCT03742154
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-15
• Study Start: 2018-12-03
• Primary Completion: 2020-04-06
• Study Completion: 2020-04-06
• Results First Submitted: 2020-08-27
• Results First Submitted QC: 2020-09-16
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-08
• Results First Posted: 2020-10-09
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline Group	Varenicline 0.5 MG	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.

Primary Outcome Measures

Name	Time	Method
Quit Attempts	From study enrollment through end of three-month follow up	Percent of participants with any self-defined and any self-defined 24-hr quit attempt

Secondary Outcome Measures

Name	Time	Method
Conversion of Varenicline Use	At the end of the three-month follow up	Percent of participants in the sampling group using varenicline at 3-month follow up assessment.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States