Hollings Cancer Center Varenicline Sampling Study

Medical University of South Carolina (MUSC)

Status and phase: Completed; Early Phase 1

Conditions: Smoking, Cigarette; Smoking, Tobacco; Smoking; Smoking Cessation

Treatments: Drug: Varenicline 0.5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT03742154

Pro00078289

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Varenicline Group

Experimental group

Description:

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.

Treatment:

Drug: Varenicline 0.5 MG

Control Group

No Intervention group

Description:

49 participants will be enrolled in this group.