CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 313 enrolled
Drug / intervention
1.0mg Varenicline b.i.d. +2 moredrug
Likely dose
1.0mg Varenicline b.i.d.from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03557294
NCT03557294Phase 4Completed

Varenicline OTC Trial on Efficacy and Safety

Arizona State University·interventional·Posted Jun 15, 2018·Updated Sep 19, 2024

In Brief

A Phase 4 clinical trial evaluating 1.0mg Varenicline b.i.d., 0.5mg Varenicline b.i.d., and 1 other intervention for Tobacco Dependence and 2 related conditions. Completed, enrolled 313 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJun 15, 2018
Enrollment StartMay 7, 2018
Primary CompletionApr 16, 2022
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.0 years ago

Interventions

1.0mg Varenicline b.i.d.drug

Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.

0.5mg Varenicline b.i.d.drug

Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.

0.0mg placebo Varenicline b.i.d.drug

Product that looks like active varenicline, but contains no active ingredient