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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 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.

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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.

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

FieldValue
Enrollment Target 313 participants
Start Date 2018-05-07
Est. Completion 2022-04-16
Phase Phase 4

Sponsor

Arizona State University

187 total trials

What the Registry Record Tells You About NCT03557294

The ClinicalTrials.gov registry entry for NCT03557294 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 313 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 473-participant average among 188 other Smoking Cessation trials with a reported enrollment target (34% lower). The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.