NCT03557294

Varenicline OTC Trial on Efficacy and Safety

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Arizona State University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed description

Given the recent research on varenicline showing that it is more effective than nicotine patch and bupropion, and with the removal of the box warning, research is needed to assess whether smokers can use varenicline without a prescription and formal behavioral support. To test this, the primary goal of the proposed research is to test whether varenicline is a candidate for switching from prescription (Rx) to OTC, and whether a dose lower than that currently approved is as effective in an OTC environment. To understand the within-person mechanisms explaining how and when OTC varenicline might improve cessation outcomes, the investigators also propose to assess experience with OTC varenicline via (a) ecological momentary assessment (EMA). Primary Objectives: 1. To assess the safety and effectiveness of the current FDA-approved 1 mg b.i.d. varenicline for smoking cessation in comparison with placebo when used in a simulated OTC study condition. 2. To assess the safety and effectiveness of .5mg b.i.d. varenicline in comparison with 1mg b.i.d. varenicline and placebo when used in a simulated OTC study condition.

Conditions

• Tobacco Dependence
• Withdrawal Symptoms
• Smoking Cessation

Interventions

Type	Name	Description
DRUG	1.0mg Varenicline b.i.d.	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.
DRUG	0.5mg Varenicline b.i.d.	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.
DRUG	0.0mg placebo Varenicline b.i.d.	Product that looks like active varenicline, but contains no active ingredient

Timeline

• Start date: 2018-05-07
• Primary completion: 2022-04-16
• Completion: 2022-04-16
• First posted: 2018-06-15
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study