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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

A Study Evaluating the Safety of the Nasal Pump

Phase 4
Terminated
Conditions
Kerato Conjunctivitis Sicca
Dry Eye
Interventions
First Posted Date
2024-03-26
Last Posted Date
2025-05-02
Lead Sponsor
Oyster Point Pharma, Inc.
Target Recruit Count
5
Registration Number
NCT06329687
Locations
🇺🇸

United States, California, Newport Beach, California, United States

Tobacco Treatment Comparison for Cancer Care

Phase 4
Active, not recruiting
Conditions
Cancer
Smoking Cessation
Interventions
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
Active, not recruiting
Conditions
Pain
Smoking Cessation
Interventions
Other: Smoking cessation and pain management intervention
First Posted Date
2023-09-08
Last Posted Date
2025-03-19
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
Behavioral: Counseling
Behavioral: Guided Self-Change Booklets
First Posted Date
2023-09-07
Last Posted Date
2025-05-06
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
2025-05-08
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
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

Switching to E-cigarettes in African-American Smokers

Phase 3
Recruiting
Conditions
Smoking Reduction
Interventions
Other: Electronic cigarette
Drug: Placebo
First Posted Date
2023-01-30
Last Posted Date
2024-12-20
Lead Sponsor
University of Kansas Medical Center
Target Recruit Count
500
Registration Number
NCT05703672
Locations
🇺🇸

Swope Health Central, Kansas City, Missouri, United States

🇺🇸

University of Kansas Medical Center, Kansas City, Missouri, United States

Nasal Spray Study in Sjogren's Dry Eye Disease

Phase 4
Completed
Conditions
Sjogren's Syndrome
Dry Eye
Interventions
First Posted Date
2023-01-26
Last Posted Date
2024-11-05
Lead Sponsor
University of Pennsylvania
Target Recruit Count
39
Registration Number
NCT05700422
Locations
🇺🇸

Scheie Eye Institute at the University of Pennsylvania, Philadelphia, Pennsylvania, 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)
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+
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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