Clinical trials: Varenicline
Smoking Cessation
ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking
The purpose of this study is to describe the characteristics of the smoker who wants to quit and his/her treating physician, in addition to determine the safety and effectiveness of Champix in the real-world setting of smokers in…
- Trial name
- ASIA CHOICES (NCT00808015)
- Testing
- varenicline
- Where
- 97 sites in China, India and 2 more
- Volunteers
- 1,373 people
- Sponsor
- Pfizer
Smoking Cessation
A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch) as Compared to Oral Varenicline in Adult Smokers.
1. To evaluate the absorption and elimination of varenicline Formulation A transdermal delivery system [TDS (patch)] compared to varenicline immediate release tablet (CHANTIX®). 2.
- Trial name
- NCT00661765
- Testing
- varenicline tartrate, varenicline free base
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Smoking Cessation
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric…
- Trial name
- EAGLES (NCT01456936)
- Testing
- varenicline tartrate, bupropion hydrochloride, Nicotine Replacement Therapy Patch
- Where
- 156 sites in United States, Argentina and 14 more
- Volunteers
- 8,144 people, healthy volunteers welcome
- Sponsor
- Pfizer
Smoking Cessation, Stress
Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment
This open-label study will evaluate hydroxyzine, a first-generation antihistamine, combined with varenicline, to help smokers abstain from smoking during a 12-week trial period by diminishing the nausea, stress, anxiety, and…
- Conditions
- Smoking Cessation, Stress, Sleep Disturbance, Nausea
- Trial name
- HAVE (NCT04188106)
- Testing
- Varenicline Pill, Hydroxyzine Pill
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Rose Research Center, LLC
Dry Eye Disease (DED)
Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
- Trial name
- NCT04036292
- Testing
- OC-01 (varenicline) nasal spray
- Where
- 22 sites in United States
- Volunteers
- 758 people
- Sponsor
- Oyster Point Pharma, Inc.
Smoking Cessation
Study To Evaluate Cardiac Assessments Following Different Treatments Of Smoking Cessation Medications In Subjects With And Without Psychiatric Disorders.
Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data…
- Trial name
- CATS (NCT01574703)
- Testing
- varenicline tartrate, bupropion hydrochloride, Nicotine Replacement Therapy Patch
- Where
- 134 sites in United States, Argentina and 14 more
- Volunteers
- 4,595 people, healthy volunteers welcome
- Sponsor
- Pfizer
Smoking Cessation
Post Marketing Surveillance Study of Champix in Smoking Cessation for Filipino Patients
The primary objective of this Post-Marketing Study is to monitor the safety of a novel smoking cessation drug Varenicline (Champix™) 0.5 mg and 1 mg tablets as used in clinical practice for 12 weeks among Filipino smokers.
- Trial name
- NCT00794365
- Testing
- Varenicline
- Volunteers
- 330 people
- Sponsor
- Pfizer
Tobacco Use
Comparative Tobacco Interventions for Individuals With Severe and Persisting Behavioral Health Disorders
The aim of this pilot intervention is to examine the acceptability of a harm reduction intervention approach to tobacco use for individuals with serious behavioral health disorders and its association with a decrease in smoking.
- Trial name
- THRRP (NCT04523948)
- Testing
- Behavioral and pharmacological support to reduce combustible tobacco use.
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Rose Research Center, LLC
Smoking Cessation
A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers
This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.
- Trial name
- NCT00463918
- Testing
- varenicline
- Where
- 16 sites in United States, United Kingdom
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Pfizer
Smoking Cessation
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.
- Trial name
- NCT00282984
- Testing
- Varenicline
- Where
- 39 sites in United States, Argentina and 13 more
- Volunteers
- 714 people
- Sponsor
- Pfizer
Smoking Cessation, Depression
Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not…
- Trial name
- NCT01078298
- Testing
- varenicline
- Where
- 41 sites in United States, Bosnia and Herzegovina and 6 more
- Volunteers
- 525 people
- Sponsor
- Pfizer
Smoking Cessation, Harm Reduction
Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction
This open-label study will explore the impact of varenicline on the process of switching from combustible cigarettes (CC) to an e-cigarette.
- Trial name
- EVAR (NCT04210180)
- Testing
- Varenicline, e-cigarette
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Rose Research Center, LLC
Smoking Cessation
"VIBRATIONS" - A Study In Smokers Who Are Willing And Motivated To Stop Smoking With The Aid Of Varenicline Which Will Be Prescribed According To Usual Clinical Practice In Germany
The aim of this study is to determine the success rates for stopping smoking with varenicline in Germany. The main measure of success will be continuous abstinence from smoking (not a single puff) in the last week of the standard…
- Trial name
- VIBRATIONS (NCT01104636)
- Testing
- Varenicline
- Volunteers
- 1,177 people
- Sponsor
- Pfizer
Pharmacokinetics, Bioavailability
An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation
1. To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions. 2.
- Conditions
- Pharmacokinetics, Bioavailability, Smoking Cessation
- Trial name
- NCT00731562
- Testing
- Varenicline Tartrate Controlled Release
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Dry Eye, Keratoconjunctivitis Sicca
Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya
The objective of this study is to determine the safety of the nasal guide when utilized to aid in the administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray
- Trial name
- NCT05918406
- Testing
- Nasal Guide
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Oyster Point Pharma, Inc.
Schizophrenia
A 6-Week Multicenter Trial Of Varenicline Tartrate For Cognitive Impairment In Subjects With Schizophrenia
The primary objective of this protocol is to assess the efficacy of two dose strengths of varenicline (0.5 mg BID and 1mg BID) as adjunctive treatment for cognitive impairment in symptomatically stable outpatient schizophrenic…
- Trial name
- NCT00743847
- Testing
- varenicline
- Sponsor
- Pfizer
Smoking Cessation
A Study to Evaluate the Safety and Efficacy of Three Doses of a Controlled Release Formulation of Varenicline for Smoking Cessation
The purpose of this study is to evaluate the safety, efficacy, and tolerability of twice daily (BID) administration of three dose strengths (1.2 mg, 1.8 mg, and 2.4 mg) of varenicline controlled release (CR) tablets in adult…
- Trial name
- NCT00741884
- Testing
- Varenicline Controlled Release 1.2 mg, Varenicline Controlled Release 1.8 mg, Varenicline Controlled Release 2.4 mg
- Sponsor
- Pfizer
Smoking Cessation
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation
The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.
- Trial name
- NCT00143364
- Testing
- varenicline (CP-526,555)
- Where
- 15 sites in United States
- Volunteers
- 1,005 people
- Sponsor
- Pfizer
Healthy Subjects
Evaluating Relative Bioavailability of OC-01 (Varenicline) Nasal Spray as Compared to Orally Administered Varenicline
To assess the relative bioavailability of varenicline administered intranasally at its highest intended clinical strength compared to varenicline administered orally at its highest oral tablet strength.
- Trial name
- NCT04072146
- Testing
- Vaenicline oral tablet 1 mg, then OC-01 (varenicline solution) nasal spray 0.12 mg, OC-01 (varenicline solution) nasal spray 0.12 mg then Varenicline oral tablet 1 mg
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Oyster Point Pharma, Inc.
Smoking Cessation
A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline
The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.
- Trial name
- NCT00143299
- Testing
- varenicline (CP-526,555)
- Where
- 9 sites in United States, Australia
- Volunteers
- 375 people
- Sponsor
- Pfizer