Clinical trials: Smoker
Healthy Smokers
Nicotine Patch - Bioequivalence Study
The purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications
- Trial name
- NCT02089308
- Testing
- Test treatment : V0116 transdermal patch, Reference treatment : Nicotine transdermal patch
- Where
- France
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Smoking
Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting
The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the levels of biomarkers of exposure for selected…
- Trial name
- NCT01970982
- Testing
- Tobacco Heating System (THS 2.2), Smoking abstinence (SA), Conventional cigarette (CC)
- Where
- Japan
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Migraine
A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder
This study is an open-label, parallel group study to evaluate acute pulmonary safety and Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation powder in three groups of adults: those with…
- Trial name
- NCT02905227
- Testing
- CVT-427 (zolmitriptan inhalation powder)
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Acorda Therapeutics
Tobacco Use
A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product
The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.
- Trial name
- NCT04079933
- Testing
- Oral tobacco-derived nicotine product (OTDN)
- Where
- 3 sites in United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Altria Client Services LLC
Smoking
Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.
The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette…
- Trial name
- NCT02503254
- Testing
- CHTP 1.0, Conventional Cigarette (CC)
- Where
- Poland
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Chronic Obstructive Pulmonary Disease
QVA Mechanistic Efficacy Study (Receptor Effects, Etc)
The purpose of this study was to assess global ventilated lung volume in moderate to severe COPD patients using MRI lung imaging after treatment with QVA149 compared to placebo.
- Trial name
- NCT02634983
- Testing
- QVA149
- Where
- 3 sites in United Kingdom
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Smoking Behaviors
Nicotine Pouch Pharmacokinetics Abuse Liability
Nicotine pharmacokinetics and subjective effects of Investigational Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design.
- Trial name
- NCT07476144
- Testing
- Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.
- Where
- 2 sites in United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- JT International SA
NSCLC
A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue to Smoke After Failure of One or Two Prior Chemotherapy Regimens
This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in patients with advanced NSCLC who currently smoke. Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers.
- Trial name
- NCT00294736
- Testing
- Tarceva
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 57 people
- Sponsor
- OSI Pharmaceuticals
Tobacco Dependence
Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.
- Trial name
- NCT01084707
- Testing
- Oral Nicotine, Nicotine Lozenge, Nicotine gum
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- McNeil AB
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
Tobacco Use Disorder
A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers
This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 2 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 2 mg) in healthy smokers under fasting…
- Trial name
- NCT03541044
- Testing
- Nicotine Prototype Mini lozenge, Nicorette Mini Lozenge
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Oxidative Stress, Healthy Aging
Efficacy of Solarplast for Health and Oxidative Stress
Solarplast is a unique mixture of antioxidant enzymes and single antioxidant molecules that are capable of attack oxidants that cause damage to the cells in the human body and cause premature aging.
- Conditions
- Oxidative Stress, Healthy Aging, Skin Health
- Trial name
- NCT04144777
- Testing
- Solarplast
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Deerland Enzymes
Smoking Cessation
A Multi-National Study To Assess How Effective And Safe The Smoking Cessation Medicine Varenicline Is In Smokers Who Have Already Tried Varenicline In The Past As A Prescription Medicine From Their Usual Healthcare Provider
The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment.
- Trial name
- NCT01244061
- Testing
- Varenicline
- Where
- 37 sites in United States, Australia and 6 more
- Volunteers
- 498 people
- Sponsor
- Pfizer
Tobacco Dependence
Single-dose Nicotine Pharmacokinetics With Four Oral Nicotine Replacement Products
Single-dose nicotine pharmacokinetics with four oral nicotine replacement products. A study in healthy smokers.
- Trial name
- NCT01234896
- Testing
- Nicotine Medicated Gum, 4 mg Nicotine Gum, 2 mg Nicotine Gum
- Where
- Sweden
- Volunteers
- 44 people
- Sponsor
- McNeil AB
Smoking Cessation
Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers
The primary objective of this trial is to assess the effects of cytisinicline at therapeutic and supratherapeutic doses on cardiac repolarization relative to placebo in healthy adult subjects who are smokers.
- Trial name
- NCT05566288
- Testing
- Cytisinicline, Moxifloxacin
- Where
- Portugal
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Achieve Life Sciences
Chronic Obstructive Pulmonary Disease (COPD)
Aclidinium/Formoterol Fixed Combination Dose Finding Study
The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials
- Trial name
- NCT00626522
- Testing
- Aclidinium bromide and formoterol
- Where
- 9 sites in Australia, Czechia and 2 more
- Volunteers
- 808 people
- Sponsor
- AstraZeneca
Substance Dependence
A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy Smokers
Study to investigate the safety, tolerability and pharmacokinetics of GSK598809 in otherwise healthy volunteers. This study is required because this drug is being developed for the treatment of nicotine dependence.
- Trial name
- NCT00728052
- Testing
- GSK598809
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers, Moderate to Heavy Smokers
Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects
Open label study of Pracinostat will be tested to assess the effect of food on the single-dose pharmacokinetics in healthy non-smoking and smoking adult subjects under fasted and fed conditions.
- Conditions
- Healthy Volunteers, Moderate to Heavy Smokers, Non-smokers
- Trial name
- HVFE (NCT02058784)
- Testing
- pracinostat
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Helsinn Healthcare SA
Healthy Smokers
Nicotine Patch Bioequivalence Study
The purpose of this study is to compare the relative bioavailability of nicotine following single application of a new transdermal formulation to that of a reference formulation.
- Trial name
- NCT01658202
- Testing
- V0116 transdermal patch (Test treatment ), Nicotine transdermal patch (Reference Treatment )
- Where
- France
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Smoking, Tobacco
A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers
The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine…
- Trial name
- NCT07598136
- Testing
- P2613422, P2611222, P2615522
- Where
- 7 sites in United States
- Volunteers
- 1,280 people, healthy volunteers welcome
- Sponsor
- RAI Services Company