Hollings Cancer Center Varenicline Sampling Study

Smoking Cessation Clinical Trial

Official title:

A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742154
• Other study ID #: Pro00078289
• Status: Completed
• Phase: Early Phase 1
• Start date: December 3, 2018
• Est. completion date: April 6, 2020

Study information

• Verified date: October 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 6, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation
• Smoking, Cigarette
• Smoking, Tobacco

Intervention

Drug:
• Varenicline 0.5 MG
varenicline comes in bottles of 56 - 0.5 mg pills

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit Attempts	Percent of participants with any self-defined and any self-defined 24-hr quit attempt	From study enrollment through end of three-month follow up
Secondary	Conversion of Varenicline Use	Percent of participants in the sampling group using varenicline at 3-month follow up assessment.	At the end of the three-month follow up