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

Evaluating Smoking Cessation Interventions for PWH in South Africa

Phase 2

Recruiting

Conditions: Smoking Cessation
Comorbidities and Coexisting Conditions
HIV

Interventions: Drug: Nicotine patch
Drug: Varenicline
Behavioral: Intensive Behavioral Counselling
Drug: Nicotine gum
Behavioral: Peer Counselling

First Posted Date: 2022-06-09

Last Posted Date: 2024-08-09

Lead Sponsor: Johns Hopkins University

Target Recruit Count: 660

Registration Number: NCT05413122

Locations: 🇿🇦
Perinatal HIV Research Unit (PHRU), Soweto, Gauteng, South Africa

Varenicline for the Treatment of Cannabis and Tobacco Use Disorders in Veterans

Phase 2

Withdrawn

Conditions: Cannabis Use Disorder
Tobacco Use Disorder

Interventions: Drug: Varenicline
Drug: Placebo

First Posted Date: 2022-03-24

Last Posted Date: 2024-08-27

Lead Sponsor: VA Office of Research and Development

Registration Number: NCT05294263

Locations: 🇺🇸
Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston, South Carolina, United States

Wellness Intervention for Smoking and HIV

Not Applicable

Recruiting

Conditions: Smoking Cessation
HIV
Cardiovascular Diseases
Sleep

Interventions: Drug: Varenicline
Behavioral: Smoking Cessation Counseling
Other: Health Approach 2 to Reduce Smoking
Behavioral: Health Approach 1 to Reduce Smoking

First Posted Date: 2021-01-27

Last Posted Date: 2024-02-08

Lead Sponsor: University of Arizona

Target Recruit Count: 200

Registration Number: NCT04725617

Locations: 🇺🇸
Banner University Medical Center Phoenix, Phoenix, Arizona, United States
🇺🇸
University of Arizona, Tucson, Arizona, United States

Effectiveness of an Enhanced Tobacco Intervention Protocol Compared to Standard Treatment in Helping Head and Neck and Lung Cancer Patients Starting Treatment to Reduce Cigarette Use

Not Applicable

Active, not recruiting

Conditions: Head and Neck Squamous Cell Carcinoma
Lung Non-Small Cell Carcinoma

Interventions: Drug: Nicotine Replacement
Drug: Bupropion Hydrochloride Controlled-release
Other: Quality of Life Assessment
Other: Best Practice
Drug: Varenicline
Other: Tobacco Cessation Counseling
Other: Questionnaire Administration

First Posted Date: 2021-01-05

Last Posted Date: 2024-05-13

Lead Sponsor: Thomas Jefferson University

Target Recruit Count: 40

Registration Number: NCT04694846

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy, Philadelphia, Pennsylvania, United States
🇺🇸
Jefferson Health, Methodist Hospital, Philadelphia, Pennsylvania, United States

Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

Phase 2

Recruiting

Conditions: Cancer, Treatment-Related
Smoking Cessation

Interventions: Drug: Bupropion
Drug: Long-acting nicotine replacement therapy
Drug: Varenicline
Behavioral: High-intensity counseling
Behavioral: Low-intensity counseling
Other: No nicotine replacement therapy
Drug: Nicotine Replacement Products

First Posted Date: 2020-11-18

Last Posted Date: 2024-06-07

Lead Sponsor: Joseph Valentino, MD

Target Recruit Count: 126

Registration Number: NCT04634071

Locations: 🇺🇸
Kings Daughters Medical Center - Ashland, Ashland, Kentucky, United States
🇺🇸
Med Center Health, Bowling Green, Kentucky, United States
🇺🇸
University Of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States

and more 1 locations

Nicotine Replacement Therapy, Counseling, Varenicline, and Bupropion for Smoking Cessation, the PISCES I Trial

Phase 4

Recruiting

Conditions: Cigarette Smoking-Related Carcinoma

Interventions: Drug: Nicotine Replacement
Drug: Bupropion Hydrochloride Controlled-release
Other: Questionnaire Administration
Drug: Varenicline
Other: Tobacco Cessation Counseling

First Posted Date: 2020-10-27

Last Posted Date: 2024-10-01

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 2010

Registration Number: NCT04604509

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents

Phase 4

Terminated

Conditions: Vaping
Nicotine Dependence

Interventions: Drug: Placebo
Drug: Varenicline

First Posted Date: 2020-10-26

Last Posted Date: 2024-04-04

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 5

Registration Number: NCT04602494

Locations: 🇺🇸
Center for Addiction Medicine, Boston, Massachusetts, United States

Metabolism Informed Smoking Treatment: The MIST RCT

Phase 3

Active, not recruiting

Conditions: Smoking

Interventions: Behavioral: Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.
Drug: Nicotine Replacement Therapy
Drug: Varenicline
Other: Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)

First Posted Date: 2020-10-19

Last Posted Date: 2024-12-05

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 608

Registration Number: NCT04590404

Locations: 🇺🇸
Vanderbilt University Medical Center ViTAL, Vanderbilt Center for Tobacco, Addiction, and Lifestyle General Internal Medicine and Public Health 2525 West End Ave, Suite 450, Nashville, Tennessee, United States

A Smart Approach to Treating Tobacco Use Disorder in Persons Living With HIV

Phase 4

Active, not recruiting

Conditions: Tobacco Use Cessation

Interventions: Drug: Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler
Drug: Varenicline or bupropion
Behavioral: Contingency Management

First Posted Date: 2020-07-28

Last Posted Date: 2025-01-09

Lead Sponsor: Yale University

Target Recruit Count: 320

Registration Number: NCT04490057

Locations: 🇺🇸
SUNY Downstate STAR Clinic, Brooklyn, New York, United States
🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

and more 1 locations

Financial Incentives for Homeless Smokers: A Community-based RCT

Not Applicable

Completed

Conditions: Tobacco Smoking

Interventions: Drug: Varenicline
Behavioral: Financial incentives
Behavioral: Tobacco coaching

First Posted Date: 2020-06-24

Last Posted Date: 2024-12-05

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 184

Registration Number: NCT04445662

Locations: 🇺🇸
Boston Health Care for the Homeless Program, Boston, Massachusetts, United States

Drug Development Updates

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