Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03557294 · ClinicalTrials.gov registry record · Phase 4
Varenicline OTC Trial on Efficacy and Safety
A Phase 4 study of Smoking Cessation and Tobacco Dependence, sponsored by Arizona State University.
- Completed
- Registry status
- Phase 4
- Development phase
- 313
- Enrollment target
- 2
- Study locations
NCT03557294: Completed Phase 4 study of Smoking Cessation and Tobacco Dependence, sponsored by Arizona State University.
NCT03557294 is a Phase 4 study of Smoking Cessation and Tobacco Dependence that has completed, run by Arizona State University. The registered enrollment target is 313 participants, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (34% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03557294, a Phase 4 study of Smoking Cessation and Tobacco Dependence, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 313 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
Primary Outcome
Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - Continuous abstinence
Conditions Studied
Interventions
- DRUG 1.0mg Varenicline b.i.d.
- DRUG 0.5mg Varenicline b.i.d.
- DRUG 0.0mg placebo Varenicline b.i.d.
Study Locations (2)
Arizona
- Arizona State University - Phoenix
California
- Los Angeles Clinical Trials - Burbank
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2018-05-07 |
| Est. Completion | 2022-04-16 |
| Phase | Phase 4 |
What the finished NCT03557294 record still lists
NCT03557294 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (34% lower).
The record links to 3 conditions, with Smoking Cessation appearing as the primary indexed condition, and to 3 interventions - of which 1.0mg Varenicline b.i.d. is the first listed.
NCT03557294 reports a single indexed study location in Arizona, California.
Frequently Asked Questions
What is clinical trial NCT03557294 about?
NCT03557294 is a clinical study titled "Varenicline OTC Trial on Efficacy and Safety". The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
What is the current status of trial NCT03557294?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 313 participants. The study started on 2018-05-07. Estimated completion is 2022-04-16.
What conditions does trial NCT03557294 study?
This clinical trial studies the following conditions: Smoking Cessation, Tobacco Dependence, Withdrawal Symptoms.
What interventions are being tested in trial NCT03557294?
The interventions under investigation include: 1.0mg Varenicline b.i.d. (DRUG), 0.5mg Varenicline b.i.d. (DRUG), 0.0mg placebo Varenicline b.i.d. (DRUG).
Who is sponsoring clinical trial NCT03557294?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03557294 being conducted?
This trial has 2 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoking Cessation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03557294's enrollment target sits among peer trials
313 77th of 188 higher than 112 of 188 other Smoking Cessation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking Cessation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
RECRUITING · Phase 4
-
The Options 2 Study
RECRUITING · Phase 4
-
Smoking Cessation Program in the Construction Sector
RECRUITING · Phase 4
-
The Avenues Study: Dual Use Cessation
RECRUITING · Phase 4
-
Using Multiphase Optimization Strategy (MOST) to Optimize a Cost-effective, Sustainable and Scalable Smoking Cessation Package for Smokers in HIV Clinical Care
RECRUITING · Phase 4
-
Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites
ACTIVE NOT RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00595491 · 313 participants · Phase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
- NCT03866382 · 314 participants · Phase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
- NCT04500756 · 314 participants · Phase 2
Limiting AAA With Metformin (LIMIT) Trial
- NCT06167746 · 314 participants · Phase 3
iCare4Me Transitions
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI