Varenicline OTC Trial on Efficacy and Safety

PHASE4CompletedINTERVENTIONAL
Enrollment

313

Participants

Timeline

Start Date

May 7, 2018

Primary Completion Date

April 16, 2022

Study Completion Date

April 16, 2022

Conditions
Tobacco DependenceWithdrawal SymptomsSmoking Cessation
Interventions
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

Trial Locations (2)

85004

Arizona State University, Phoenix

91505

Los Angeles Clinical Trials, Burbank

Sponsors
All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

Los Angeles Clinical Trials

UNKNOWN

collaborator

University of Nevada, Reno

OTHER

collaborator

Pfizer

INDUSTRY

lead

Arizona State University

OTHER