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Varenicline

Generic Name
Varenicline
Brand Names
Champix, Chantix, Tyrvaya
Drug Type
Small Molecule
Chemical Formula
C13H13N3
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

Reducing Falls with Varenicline in Hypocholinergic Parkinson Disease

Phase 2
Not yet recruiting
Conditions
Parkinson Disease
Interventions
Drug: Placebo
Drug: Varenicline
First Posted Date
2024-11-07
Last Posted Date
2024-11-07
Lead Sponsor
Vikas Kotagal
Target Recruit Count
102
Registration Number
NCT06679374
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

Neural Mechanisms Connecting Deficient Sleep and Smoking Relapse

Phase 2
Not yet recruiting
Conditions
Tobacco Use
Tobacco Cessation
Insomnia
Interventions
Behavioral: Experimental health intervention
Drug: Varenicline
First Posted Date
2024-09-24
Last Posted Date
2025-01-09
Lead Sponsor
Yale University
Target Recruit Count
114
Registration Number
NCT06609369
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

The Avenues Study: Dual Use Cessation

Phase 4
Not yet recruiting
Conditions
Smoking Cessation
Electronic Cigarette Use
Interventions
Drug: Nicotine patch
Drug: Varenicline
Behavioral: Dual Focused Cessation Counseling
Behavioral: Smoking Focused Cessation Counseling
First Posted Date
2024-06-25
Last Posted Date
2024-06-25
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
500
Registration Number
NCT06474299
Locations
🇺🇸

University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, United States

Tobacco Treatment Comparison for Cancer Care

Phase 4
Active, not recruiting
Conditions
Cancer
Smoking Cessation
Interventions
Drug: Transdermal Nicotine Patch
Drug: Varenicline
Behavioral: Standard Telephone Counseling
Behavioral: Cancer-Targeted Telephone Counseling
Other: Mailed Information about Standard Care Resources
First Posted Date
2024-01-23
Last Posted Date
2024-12-04
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
52
Registration Number
NCT06218823
Locations
🇺🇸

UW Carbone Cancer Center, Madison, Wisconsin, United States

Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors.

Phase 4
Recruiting
Conditions
Pain
Smoking Cessation
Interventions
Other: Smoking cessation and pain management intervention
Drug: Varenicline
First Posted Date
2023-09-08
Last Posted Date
2024-10-10
Lead Sponsor
Duke University
Target Recruit Count
20
Registration Number
NCT06029907
Locations
🇺🇸

Duke University Health System, Durham, North Carolina, United States

Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use

Phase 1
Recruiting
Conditions
Cigarette Smoking
Smoking Cessation
E-Cigarette Use
Interventions
Drug: Varenicline
Behavioral: Counseling
Behavioral: Guided Self-Change Booklets
First Posted Date
2023-09-07
Last Posted Date
2024-06-28
Lead Sponsor
Yale University
Target Recruit Count
40
Registration Number
NCT06027840
Locations
🇺🇸

Yale University, New Haven, Connecticut, United States

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2

Phase 2
Not yet recruiting
Conditions
Hiv
Alcohol Use Disorder
Tobacco Use Disorder
Interventions
First Posted Date
2023-08-23
Last Posted Date
2025-01-03
Lead Sponsor
Yale University
Target Recruit Count
30
Registration Number
NCT06006143
Locations
🇺🇸

Atlanta VA Medical Center, Decatur, Georgia, United States

V+PSF-M for Tobacco Cessation in HIV Care in India

Phase 3
Recruiting
Conditions
Smoking, Tobacco
Smoking Cessation
Human Immunodeficiency Virus
Interventions
Behavioral: Standard Care
Drug: Varenicline
Behavioral: Positively Smoke Free Mobile (PSF-M)
First Posted Date
2023-03-27
Last Posted Date
2024-12-10
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
400
Registration Number
NCT05786547
Locations
🇮🇳

VHS Infectious Disease Medical Centre, CART Clinical Research Site, Chennai, Tamil Nadu, India

🇺🇸

University of Colorado, Aurora, Colorado, United States

Botswana Smoking and Abstinence Reinforcement Trial

Phase 4
Conditions
Smoking Cessation
Hiv
Interventions
Behavioral: Screening, Brief Intervention and Referral to Treatment (SBIRT) intervention consisting of the 5As, (Ask, Advise, Assess, Assist, Arrange)
Drug: Varenicline
First Posted Date
2023-01-23
Last Posted Date
2024-11-13
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
750
Registration Number
NCT05694637
Locations
🇧🇼

Tutume Primary Hospital, Tutume, Central, Botswana

🇧🇼

Masego Clinic, Francistown, Central, Botswana

🇧🇼

Sefhare Primary Hospital, Sefhare, Central, Botswana

and more 7 locations

Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes

Not Applicable
Recruiting
Conditions
Hiv
Tobacco Use
Interventions
Behavioral: EX+
Drug: Varenicline
Behavioral: TAU
Behavioral: HR
First Posted Date
2022-12-08
Last Posted Date
2024-12-27
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
400
Registration Number
NCT05642715
Locations
🇺🇸

Montefiore Medical Center, Bronx, New York, United States

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