Hollings Cancer Center Varenicline Sampling Study

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Smoking Cessation; Smoking, Tobacco; Smoking, Cigarette
• Intervention / Treatment: Drug: Varenicline 0.5 MG

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varenicline Group; 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.	Drug: Varenicline 0.5 MG; varenicline comes in bottles of 56 - 0.5 mg pills; Other Names: Chantix; Varenicline Pill
No Intervention: Control Group; 49 participants will be enrolled in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Publications and helpful links

General Publications

• Carpenter MJ, Gray KM, Wahlquist AE, Cropsey K, Saladin ME, Froeliger B, Smith TT, Toll BA, Dahne J. A Pilot Randomized Clinical Trial of Remote Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation. Nicotine Tob Res. 2021 May 24;23(6):983-991. doi: 10.1093/ntr/ntaa241.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): April 6, 2020
• Study Completion (Actual): April 6, 2020

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: Pro00078289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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