Clinical trial NCT03742154: Hollings Cancer Center Varenicline Sampling Study
Official title: A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Smoking
Smoking Cessation
Smoking, Tobacco
Smoking, Cigarette
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of the two study groups, like drawing numbers from a hat. One group will receive a mailed sample of varenicline, and the other will not. Participants have 50/50 chance of being in either group. Both groups will contain equal numbers of smokers motivated to quit and smokers not currently motivated to quit.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quit Attempts
timeFrame: From study enrollment through end of three-month follow up
Secondary outcomes:
measure: Conversion of Varenicline Use
timeFrame: At the end of the three-month follow up
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: 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.