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Completed

NCT Number: NCT03742154

Hollings Cancer Center Varenicline Sampling Study

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.

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Key information

Conditions

Smoking Behavior Cigarette Smoking Health Behavior Smoking Cessation Smoking, Cigarette Smoking, Tobacco Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Varenicline 0.5 MG

Drug

varenicline comes in bottles of 56 - 0.5 mg pills

Other names: Chantix, Varenicline Pill

Primary outcomes

  1. Quit Attempts

    Time frame: 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 outcomes

  1. Conversion of Varenicline Use

    Time frame: At the end of the three-month follow up

    Percent of participants in the sampling group using varenicline at 3-month follow up assessment.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2018
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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