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

Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study)

Phase 3

Completed

Conditions: Tobacco Dependence
Smoking Cessation

Interventions: Drug: Nicotine Patch
Drug: Placebo
Drug: Varenicline

First Posted Date: 2010-08-19

Last Posted Date: 2012-10-11

Lead Sponsor: Queen Mary University of London

Target Recruit Count: 117

Registration Number: NCT01184664

Locations: 🇬🇧
Tobacco Dependence Research Unit, London, United Kingdom
🇬🇧
Tobacco Dependence Research and Treatment Unit, London, United Kingdom

Varenicline and Alcohol in Inpatient Addictions Program (IAP)

Phase 3

Terminated

Conditions: Alcoholism
Nicotine Dependence

Interventions: Drug: Varenicline

First Posted Date: 2010-07-26

Last Posted Date: 2019-03-20

Lead Sponsor: Mayo Clinic

Target Recruit Count: 1

Registration Number: NCT01169610

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

Maintaining Nonsmoking

Phase 3

Completed

Conditions: Nicotine Dependence

Interventions: Drug: Varenicline
Behavioral: Initial Individual counseling
Behavioral: Check-ins with medical staff
Behavioral: Extended Individual Counseling - Health Model
Behavioral: Extended Individual Counseling - Relapse Prevention Model

First Posted Date: 2010-07-14

Last Posted Date: 2020-11-12

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 216

Registration Number: NCT01162239

Locations: 🇺🇸
University of California San Francisco, San Francisco, California, United States

Human Behavioral Pharmacology Laboratory (HBPL) Study of Varenicline's Impact on Cocaine and Alcohol Craving

Phase 2

Completed

Conditions: Alcohol Dependence
Cocaine Dependence

Interventions: Drug: Placebo
Drug: Varenicline

First Posted Date: 2010-06-28

Last Posted Date: 2020-08-18

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 15

Registration Number: NCT01151813

Locations: 🇺🇸
University of Pennsylvania, Treatment Research Center, Philadelphia, Pennsylvania, United States

Varenicline for Alcohol Dependence

Phase 2

Completed

Conditions: Alcoholism

Interventions: Drug: Placebo
Drug: Varenicline

First Posted Date: 2010-06-17

Last Posted Date: 2014-08-27

Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Target Recruit Count: 200

Registration Number: NCT01146613

Locations: 🇺🇸
Dartmouth Medical School, Hanover, New Hampshire, United States
🇺🇸
Boston Medical Center, Boston, Massachusetts, United States
🇺🇸
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

and more 2 locations