Varenicline

Generic Name: Varenicline

Brand Names: Champix, Chantix, Tyrvaya

Drug Type: Small Molecule

Chemical Formula: C_₁₃H_₁₃N_₃

CAS Number: 249296-44-4

Unique Ingredient Identifier: W6HS99O8ZO

Background: Varenicline is a prescription medication used to treat smoking addiction. This medication is the first approved nicotinic receptor partial agonist. Specifically, varenicline is a partial agonist of the alpha4/beta2 subtype of the nicotinic acetylcholine receptor. In addition it acts on alpha3/beta4 and weakly on alpha3beta2 and alpha6-containing receptors. A full agonism was displayed on alpha7-receptors.

On March 9, 2015, the U.S. Food and Drug Administration warned that Varenicline, in the form of Pfizer Inc's quit-smoking drug, Chantix, has been associated with seizures and that some patients who drink while taking the drug may become aggressive or black out. Pfizer is conducting an additional safety study of the drug, results of which are expected in late 2015. The FDA said it is keeping the black box in place at least until the results of the trial are announced.

Indication: For use as an aid in smoking cessation.

Varenicline as a nasal spray is indicated for the symptomatic treatment of dry eye disease.

Associated Conditions: Dry Eye Syndrome (DES)

Associated Therapies: Smoking, Cessation

Clinical Trials

Addressing Post Cessation Weight Gain

Phase 2

Terminated

Conditions: Smoking Cessation
Obesity

Interventions: Drug: Varenicline
Drug: lorcaserin
Drug: Placebo

First Posted Date: 2015-04-09

Last Posted Date: 2021-06-10

Lead Sponsor: Mayo Clinic

Target Recruit Count: 84

Registration Number: NCT02412631

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Lorcaserin for Preventing Weight Gain Among Smokers

Phase 1

Completed

Conditions: Weight Gain
Tobacco Use Disorder

Interventions: Drug: Varenicline
Drug: Lorcaserin

First Posted Date: 2015-03-19

Last Posted Date: 2017-06-06

Lead Sponsor: Mayo Clinic

Target Recruit Count: 20

Registration Number: NCT02393547

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Behavioral Activation and Varenicline for Smoking Cessation in Depressed Smokers

Phase 4

Completed

Conditions: Nicotine Dependence
Major Depressive Disorder

Interventions: Behavioral: Standard treatment
Behavioral: BASC
Drug: Varenicline

First Posted Date: 2015-03-04

Last Posted Date: 2021-07-29

Lead Sponsor: Northwestern University

Target Recruit Count: 300

Registration Number: NCT02378714

Locations: 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States

Advancing Tobacco Use Treatment for African American Smokers

Phase 4

Completed

Conditions: Smoking Cessation

Interventions: Drug: Chantix
Drug: Placebo

First Posted Date: 2015-02-10

Last Posted Date: 2020-07-15

Lead Sponsor: Lisa Sanderson Cox, PhD

Target Recruit Count: 500

Registration Number: NCT02360631

Locations: 🇺🇸
Swope Health Central, Kansas City, Missouri, United States
🇺🇸
University of Kansas Medical Center, Kansas City, Kansas, United States