Clinical trial · Interventional
Hollings Cancer Center Varenicline Sampling Study
A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Smoking | — | UNRESOLVED | — |
| Smoking Cessation | — | UNRESOLVED | — |
| Smoking, Cigarette | — | UNRESOLVED | — |
| Smoking, Tobacco | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Varenicline 0.5 MG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Varenicline 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.
- interventionNames
- Drug: Varenicline 0.5 MG
- type
- NO_INTERVENTION
- label
- Control Group
- description
- 49 participants will be enrolled in this group.
Primary outcomes (1)
- measure
- Quit Attempts
- timeFrame
- From study enrollment through end of three-month follow up
- description
- Percent of participants with any self-defined and any self-defined 24-hr quit attempt
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCarpenter 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. PMID 33249458