MedPath

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

Cannabis-Tobacco Co-Use Treatment Study

Phase 3
Recruiting
Conditions
Tobacco Use Disorder
Tobacco Use Cessation
Cannabis Use
Cannabis Use Disorder
Marijuana Use
Interventions
Behavioral: Counseling
Behavioral: Psychosocial modules
First Posted Date
2025-03-19
Last Posted Date
2025-05-08
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
200
Registration Number
NCT06883162
Locations
🇺🇸

Medical University of South Carolina - Charleston, Charleston, South Carolina, United States

A Study of Varenicline in the Treatment of Visceral Sensation

Phase 1
Recruiting
Conditions
Irritable Bowel Syndrome
Interventions
First Posted Date
2025-03-03
Last Posted Date
2025-04-27
Lead Sponsor
Mayo Clinic
Target Recruit Count
8
Registration Number
NCT06854406
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Combination Nicotine Replacement Therapy, Cytisine, or Varenicline for Smoking Cessation

Phase 4
Recruiting
Conditions
Tobacco
Interventions
Drug: Nicotine Replacement Therapy (Nicotine patch plus NRT gum or lozenge)
First Posted Date
2025-02-18
Last Posted Date
2025-05-04
Lead Sponsor
Ottawa Heart Institute Research Corporation
Target Recruit Count
1500
Registration Number
NCT06832085
Locations
🇨🇦

University of Ottawa Heart Institute, Ottawa, Ontario, Canada

TDCS Plus Varenicline for Smoking Cessation

Phase 4
Not yet recruiting
Conditions
Tobacco Smoking
Nicotine Use Disorder
Tobacco Use Disorder
Substance Use Disorders
Nicotine Dependence
Smoking Cessation
Interventions
Device: Active Transcranial Direct Current Stimulation (tDCS)
Device: Sham Transcranial Direct Current Stimulation (tDCS)
First Posted Date
2025-01-29
Last Posted Date
2025-02-26
Lead Sponsor
Centre for Addiction and Mental Health
Target Recruit Count
160
Registration Number
NCT06798324
Locations
🇨🇦

Centre for Addiction and Mental Health, Toronto, Ontario, Canada

Efficacy of Varenicline Tartrate in Frequent Premature Ventricular Contractions

Phase 3
Not yet recruiting
Conditions
Premature Ventricular Contraction (PVC)
Interventions
First Posted Date
2025-01-17
Last Posted Date
2025-01-20
Lead Sponsor
Shanghai East Hospital
Target Recruit Count
116
Registration Number
NCT06780215
Locations
🇨🇳

Shanghai East Hospital, Shanghai, Shanghai, China

E-cigarette Cessation in Adults Who Co-use Cannabis

Phase 4
Recruiting
Conditions
Nicotine Dependence
Tobacco Use Disorder
Interventions
Behavioral: Contingency management
Behavioral: Counseling
First Posted Date
2024-11-14
Last Posted Date
2025-02-20
Lead Sponsor
Medical University of South Carolina
Target Recruit Count
105
Registration Number
NCT06688539
Locations
🇺🇸

MUSC Charleston, Charleston, South Carolina, United States

🇺🇸

MUSC Lancaster, Lancaster, South Carolina, United States

🇺🇸

Behavioral Health Services of Pickens County, Pickens, South Carolina, United States

Reducing Falls With Varenicline in Hypocholinergic Parkinson Disease

Phase 2
Recruiting
Conditions
Parkinson Disease
Interventions
Drug: Placebo
First Posted Date
2024-11-07
Last Posted Date
2025-04-15
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
Recruiting
Conditions
Tobacco Use
Tobacco Cessation
Insomnia
Interventions
Behavioral: Experimental health intervention
First Posted Date
2024-09-24
Last Posted Date
2025-04-29
Lead Sponsor
Yale University
Target Recruit Count
114
Registration Number
NCT06609369
Locations
🇺🇸

Connecticut Mental Health Center, New Haven, Connecticut, United States

🇺🇸

Yale University, New Haven, Connecticut, United States

Advancing VR-based Attentional Bias as a Biomarker for Tobacco Use Disorder

Early Phase 1
Recruiting
Conditions
Nicotine Addiction
Craving
Interventions
First Posted Date
2024-09-03
Last Posted Date
2024-11-22
Lead Sponsor
University of California, San Diego
Target Recruit Count
200
Registration Number
NCT06582888
Locations
🇺🇸

University California, San Diego, San Diego, California, United States

The Avenues Study: Dual Use Cessation

Phase 4
Recruiting
Conditions
Smoking Cessation
Electronic Cigarette Use
Interventions
Behavioral: Dual Focused Cessation Counseling
Behavioral: Smoking Focused Cessation Counseling
First Posted Date
2024-06-25
Last Posted Date
2025-04-10
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

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