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

Efficacy of the Use of Genetic Markers in the Choice of the Pharmacological Treatment of Smoking (GENTSMOKING)

Phase 4

Completed

Conditions: Genetic Predisposition
Smoking Cessation

Interventions: Drug: Varenicline Tartrate or bupropion

First Posted Date: 2017-12-05

Last Posted Date: 2022-12-21

Lead Sponsor: University of Sao Paulo General Hospital

Target Recruit Count: 361

Registration Number: NCT03362099

Locations: 🇧🇷
Ambulatório de Tratamento Tabagismo - Incor HCFMUSP, São Paulo, Brazil

EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking

Phase 3

Completed

Conditions: Tobacco Smoking

Interventions: Drug: Varenicline
Behavioral: Brief smoking cessation counseling

First Posted Date: 2017-08-25

Last Posted Date: 2023-07-11

Lead Sponsor: State University of New York at Buffalo

Target Recruit Count: 320

Registration Number: NCT03262662

Locations: 🇺🇸
State University of New York at Buffalo, Buffalo, New York, United States

Efficacy and Safety of E-cigarettes for Smoking Cessation in Middle-aged Heavy Smokers

Phase 4

Completed

Conditions: Smoking Cessation
Electronic Cigarette

Interventions: Drug: Varenicline Tartrate
Drug: Nicotine
Behavioral: Motivational Interview

First Posted Date: 2017-08-01

Last Posted Date: 2024-05-16

Lead Sponsor: University of Oulu

Target Recruit Count: 450

Registration Number: NCT03235505

Locations: 🇫🇮
Lapland Central Hospital, Rovaniemi, Finland

Metabolism-informed Care for Smoking Cessation

Not Applicable

Completed

Conditions: Tobacco Use
Tobacco Use Cessation

Interventions: Other: Nicotine Metabolite Ratio
Drug: Varenicline
Drug: Bupropion
Drug: Nicotine patch

First Posted Date: 2017-07-24

Last Posted Date: 2017-07-24

Lead Sponsor: Vanderbilt University Medical Center

Target Recruit Count: 82

Registration Number: NCT03227679

UW Quitting Using Intensive Treatment Study (QUITS)

Phase 4

Completed

Conditions: Tobacco Dependence

Interventions: Drug: Varenicline
Other: Placebo Patch
Drug: Nicotine patch
Other: Placebo Pill

First Posted Date: 2017-06-06

Last Posted Date: 2023-01-23

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 1251

Registration Number: NCT03176784

Locations: 🇺🇸
UW Center for Tobacco Research and Intervention, Milwaukee, Wisconsin, United States
🇺🇸
UW Center For Tobacco Research and Intervention, Madison, Wisconsin, United States

Stage Ib Trial of mSMART With Varenicline

Phase 1

Withdrawn

Conditions: Nicotine Dependence

Interventions: Device: mSMART
Drug: Chantix

First Posted Date: 2017-03-03

Last Posted Date: 2018-04-17

Lead Sponsor: Duke University

Registration Number: NCT03069768

Locations: 🇺🇸
Duke Health Behavior Neuroscience Research Lab, Durham, North Carolina, United States

Dopamine D2/D3 Receptor Upregulation by Varenicline in Methamphetamine Users

Phase 1

Terminated

Conditions: Dopamine D2/3 Receptor Availability
Cognitive Function
Methamphetamine Abuse

Interventions: Other: Placebo
Drug: Varenicline

First Posted Date: 2017-02-23

Last Posted Date: 2024-05-08

Lead Sponsor: University of California, Los Angeles

Target Recruit Count: 62

Registration Number: NCT03059563

Locations: 🇺🇸
University of California Los Angeles, Los Angeles, California, United States

Human Laboratory Study of Varenicline for Alcohol Use Disorder

Phase 1

Completed

Conditions: Alcohol Use Disorder

Interventions: Drug: Placebo oral capsule
Drug: Varenicline

First Posted Date: 2017-01-30

Last Posted Date: 2019-10-23

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

Target Recruit Count: 47

Registration Number: NCT03035708

Locations: 🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
🇺🇸
Brown University, Providence, Rhode Island, United States

Treating Smokeless Tobacco Use in Rural Veterans

Not Applicable

Conditions: Smokeless Tobacco
Nicotine Dependence

Interventions: Behavioral: Tailored behavioral intervention
Behavioral: Tobacco quit line
Behavioral: Behavioral activation for elevated depressive symptoms
Behavioral: Educational materials
Behavioral: Post-cessation weight gain management
Behavioral: Alcohol use risk reduction
Drug: Nicotine replacement therapy - transdermal nicotine patch
Drug: Nicotine replacement therapy - nicotine lozenge
Drug: Nicotine replacement therapy - nicotine gum
Drug: Bupropion sustained release
Drug: Varenicline
Drug: Combination nicotine replacement therapy
Drug: Combination nicotine replacement therapy + bupropion

First Posted Date: 2016-12-15

Last Posted Date: 2019-07-24

Lead Sponsor: Mark Vander Weg

Target Recruit Count: 123

Registration Number: NCT02994082

Locations: 🇺🇸
Iowa City VA Healthcare System, Iowa City, Iowa, United States

Combined Bio- and Neuro- Feedback vs. Varenicline Use for Smoking Cessation

Not Applicable

Completed

Conditions: Smoking
Chronic Obstructive Pulmonary Disease (COPD)
Asthma

Interventions: Other: Biofeedback and Neurofeedback Training
Drug: Varenicline use for smoking cessation
Other: Passive Control
Other: Sham Neurofeedback

First Posted Date: 2016-12-14

Last Posted Date: 2020-02-17

Lead Sponsor: Aristotle University Of Thessaloniki

Target Recruit Count: 106

Registration Number: NCT02991781

Locations: 🇧🇬
National Association of General Practitioners in Bulgaria, Sofia, Bulgaria
🇨🇾
AAI Scientific Cultural Services Ltd (AAISCS), Nicosia, Cyprus
🇬🇷
Laboratory of Medical Physics, AUTH, Thessaloniki, Greece

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