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

Hollings Cancer Center Varenicline Sampling Study

Early Phase 1

Completed

Conditions: Smoking Cessation
Smoking, Cigarette
Smoking
Smoking, Tobacco

Interventions: Drug: Varenicline 0.5 MG

First Posted Date: 2018-11-15

Last Posted Date: 2020-10-28

Lead Sponsor: Medical University of South Carolina

Target Recruit Count: 99

Registration Number: NCT03742154

Locations: 🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)

Phase 2

Terminated

Conditions: Smoking Cessation

Interventions: Drug: Varenicline
Drug: Oral Nicotine Replacement Therapy (NRT)
Behavioral: Medication Reminders
Behavioral: Tobacco Cessation Counseling

First Posted Date: 2018-10-29

Last Posted Date: 2024-02-06

Lead Sponsor: University of Oklahoma

Target Recruit Count: 34

Registration Number: NCT03722966

Locations: 🇺🇸
TSET Health Promotion Research Center, Oklahoma City, Oklahoma, United States

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.

First Posted Date: 2018-06-15

Last Posted Date: 2022-05-02

Lead Sponsor: Arizona State University

Target Recruit Count: 307

Registration Number: NCT03557294

Locations: 🇺🇸
Arizona State University, Phoenix, Arizona, United States
🇺🇸
Los Angeles Clinical Trials, Burbank, California, United States

So-Lo-Mo Intervention Applied to the Smoking Cessation Process

Not Applicable

Completed

Conditions: Lifestyle-related Condition
Smoking Cessation
Health Behavior

Interventions: Behavioral: Psychological advice
Other: So-Lo-Mo
Drug: Bupropion Pill
Drug: Varenicline Pill

First Posted Date: 2018-06-12

Last Posted Date: 2018-12-04

Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Target Recruit Count: 240

Registration Number: NCT03553173

Balanced Placebo Design With Varenicline: Pharmacological and Expectancy Effects on Medication Adherence

Phase 4

Completed

Conditions: Medication Adherence

Interventions: Drug: Varenicline
Other: Placebo

First Posted Date: 2018-05-29

Last Posted Date: 2020-12-14

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 80

Registration Number: NCT03538808

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

PRecision Interventions for SMoking in the SCCS

Phase 2

Completed

Conditions: Tobacco Use Cessation

Interventions: Drug: Nicotine patch
Drug: Varenicline
Genetic: Nicotine metabolism
Genetic: Genetically-informed lung cancer risk score
Behavioral: NCI "Clearing the Air"

First Posted Date: 2018-05-11

Last Posted Date: 2020-06-01

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 67

Registration Number: NCT03521141

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

Phase 2

Terminated

Conditions: Tobacco Dependence

Interventions: Drug: Placebo
Drug: Varenicline

First Posted Date: 2018-04-24

Last Posted Date: 2022-05-17

Lead Sponsor: Brown University

Target Recruit Count: 5

Registration Number: NCT03507127

Locations: 🇺🇸
Brown University, 121 South Main Street, Providence, Rhode Island, United States

Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates

Phase 4

Recruiting

Conditions: Schizophrenia
Schizoaffective Disorder
Tardive Dyskinesia
Tobacco Smoking
Parkinsonism

Interventions: Drug: Varenicline

First Posted Date: 2018-04-11

Last Posted Date: 2019-03-22

Lead Sponsor: Corporal Michael J. Crescenz VA Medical Center

Target Recruit Count: 10

Registration Number: NCT03495024

Locations: 🇺🇸
Corporal Michael J Crescenz VA Medical Center, Philadelphia, Pennsylvania, United States

A Trial of Directly Observed and Long-term Varenicline

Phase 4

Active, not recruiting

Conditions: Tobacco Use Disorder
Opioid-use Disorder

Interventions: Drug: Short-Term Varenicline
Drug: Long-Term Varenicline
Behavioral: Directly Observed Therapy
Behavioral: Self Administered Therapy