Varenicline OTC Trial on Efficacy and Safety

Phase 4

Completed

• Conditions: Withdrawal Symptoms; Smoking Cessation; Tobacco Dependence
• Interventions: Drug: 0.0mg placebo Varenicline b.i.d.; Drug: 0.5mg Varenicline b.i.d.; Drug: 1.0mg Varenicline b.i.d.

• Registration Number: NCT03557294
• Lead Sponsor: Arizona State University

Brief 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.

Study Timeline

• Study Start: 2018-05-07
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-15
• Status Verified: 2022-04
• Primary Completion: 2022-04-16
• Study Completion: 2022-04-16
• Last Update Submitted: 2022-04-29
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.0mg placebo varenicline b.i.d.	0.0mg placebo Varenicline b.i.d.	Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily.
0.5mg varenicline b.i.d.	0.5mg Varenicline b.i.d.	Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study
1.0mg varenicline b.i.d.	1.0mg Varenicline b.i.d.	Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily.

Primary Outcome Measures

Name	Time	Method
The Number of Participants Who Have Continuous Abstinence as Verified by Breath Carbon Monoxide or Urine Cotinine	Week 12	Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - Continuous abstinence

Secondary Outcome Measures

Name	Time	Method
Breath Carbon Monoxide or Urine Cotinine Verified Abstinence From Smoking Cigarettes - Point Prevalence Abstinence	Week 12 visit	Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - point prevalence abstinence
Breath Carbon Monoxide Verified Abstinence From Smoking Cigarettes	Week 26	Participants who self report not smoking will be asked to have smoking status verified by breath carbon monoxide

Trial Locations

Locations (2)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States

Los Angeles Clinical Trials; 🇺🇸 Burbank, California, United States