Clinical trials: Healthy Smokers
Tobacco Use Disorder
A Bioequivalence Study of 21 Milligram (mg) Nicotine Transdermal Patches (NicoDerm CQ, GlaxoSmithKline [GSK] Dungarvan) Compared to the Current Marketed 21 mg Nicotine Transdermal Patches (NicoDerm CQ, Alza) in Healthy Adult Smokers
The purpose of this study is to assess the bioequivalence of the 21mg nicotine transdermal patch from GSK Dungarvan (Test) compared to the 21mg nicotine transdermal patch currently manufactured by Alza (Reference).
- Trial name
- NCT05024747
- Testing
- NicoDerm CQ patch (GSK Dungarvan), NicoDerm CQ (Alza)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- HALEON
Smoking Cessation
A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers
The primary objectives of this study are: To evaluate the pharmacokinetic (PK) parameters during repeat dosing of 1.5 mg or 3.0 mg cytisine when administered as the commercial 25-day schedule.
- Trial name
- NCT03303911
- Testing
- Cytisine
- Where
- United Kingdom
- Volunteers
- 26 people
- Sponsor
- Achieve Life Sciences
Smoking
Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment
The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime non-smokers as an index of endothelial function in…
- Trial name
- smoker3 (NCT02141633)
- Testing
- echocardiogram plus albuterol, airway blood flow plus albuterol, Fluticasone propionate
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Miami
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.
Healthy
Clinical Trial to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response of BI 1026706 Versus Placebo
The primary and secondary objectives of the current study are the assessments of anti-inflammatory pharmacodynamic effects on segmental endotoxin induced inflammatory response after 4 weeks treatment with BI 1026706.
- Trial name
- NCT02657408
- Testing
- BI 1026706
- Where
- Germany
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Tobacco Use Disorder
To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers
This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 4 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 4mg) in healthy smokers under fasting…
- Trial name
- NCT03543137
- Testing
- Nicotine Prototype Mini lozenge, Nicorette Mini Lozenge
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Respiratory Disorders
A Study to Assess Immunity to Specific Microbial Antigens in Healthy Smokers and Non-smokers and in Subjects With Stable COPD
The present study aims to assess the natural immunity to specific microbial antigens in healthy subjects and in subjects with stable COPD aged between 45-75 years.
- Trial name
- NCT01516437
- Testing
- Blood collection, Swab collection, Sputum collection
- Where
- 3 sites in Belgium
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Smoking
Reduced Exposure Study in Smokers Using THS 2.2 With 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 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) for…
- Trial name
- NCT01959932
- Testing
- Tobacco Heating System (THS 2.2), Smoking abstinence (SA), Conventional cigarette (CC)
- Where
- Poland
- Volunteers
- 169 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Smoking, Tobacco, Smoking
GeoScan and Remote Geo Smoking Study: Neural and Behavioral Correlates of Smokers' Exposure to Retail Environments
The purpose of the study is to learn more about the relationships between the brain, behavior, and natural daily exposure to particular environments, including the places where smokers regularly spend time and specific retail…
- Conditions
- Smoking, Tobacco, Smoking, Smoking, Cigarette
- Trial name
- NCT04279483
- Testing
- Tobacco retailer, Non-tobacco retailer
- Where
- United States
- Volunteers
- 343 people, healthy volunteers welcome
- Sponsor
- Abramson Cancer Center at Penn Medicine
COPD, Emphysema
Leukocyte Function in Chronic Obstructive Pulmonary Disease (COPD)
The aim of this study is to investigate the mechanisms whereby leukocytes are recruited to the lung in chronic obstructive pulmonary disease (COPD) and cause tissue destruction.
- Conditions
- COPD, Emphysema, Chronic Bronchitis
- Trial name
- NCT00147082
- Where
- United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Healthy Non-smoker
Matrix on Fruit Constituent Bioavailability
Primary objective is to evaluate the influence of matrix on the bioavailability of key phytochemical constituents in fruits and their subsequent effect on chronic disease risk factors.
- Trial name
- FRT (NCT01908634)
- Testing
- Milk-based Strawberry Beverage without meal, Water-Based Strawberry Beverage without meal, Milk-based strawberry Beverage with meal
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
Healthy Volunteer Smokers
Oral Tolerability Of Two Nicotine Dosage Forms
This study is to evaluate the oral tolerability of a nicotine prototype
- Trial name
- NCT00682461
- Testing
- Nicotine
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tobacco Dependence
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.
- Trial name
- NCT01084603
- Testing
- Oral Nicotine, NiQuitinTM Nicotine Lozenge, Nicorette® Nicotine Gum
- Where
- Sweden
- Volunteers
- 45 people
- Sponsor
- McNeil AB
Smoking Cessation
A Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation
This will be an open-label, randomised, 2-treatment period, single-dose crossover study to determine the comparative bioavailability and renal elimination following single-dose administration of 3.0 mg cytisine in healthy smokers…
- Trial name
- NCT03509948
- Testing
- cytisine
- Where
- United Kingdom
- Volunteers
- 13 people
- Sponsor
- Achieve Life Sciences
Smoking Cessation
Smoking Cessation Study In Healthy Adolescent Smokers
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.
- Trial name
- NCT01312909
- Testing
- Varenicline 1mg BID, Varenicline 0.5mg BID
- Where
- 80 sites in United States, Canada and 4 more
- Volunteers
- 312 people
- Sponsor
- Pfizer
Tobacco Dependence
Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab
The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.
- Trial name
- NCT01238640
- Testing
- Code STD, Code STE, Nicorette Microtab
- Where
- Sweden
- Volunteers
- 84 people
- Sponsor
- McNeil AB
Nicotine, Vaping
Reduced HPHC Exposure in Cigarette Smokers Switching to P4M3 Gen. 2.0 Compared to Continuing Smoking, or Smoking Abstinence
To demonstrate the reduction of Biomarkers of Exposure (BoExp) to selected harmful and potentially harmful constituents (HPHC) in smokers switching from cigarette (CIG) to P4M3, an Electronic Nicotine Delivery System (ENDS)…
- Conditions
- Nicotine, Vaping, Nicotine Vaping
- Trial name
- NCT05487456
- Testing
- P4M3 CA35, P4M3 CM35, CIG
- Where
- United Kingdom
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Healthy Volunteers
A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes
This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and consumer satisfaction, over 8 days.
- Trial name
- NCT04430634
- Testing
- Myblu variant A, Myblu variant B, Myblu variant C
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Fontem US LLC
Smoking, Tobacco Smoking
Reduced Exposure to HPHC in Smokers Switching From Cigarettes to Different Versions of THS
This was a randomized, controlled, open-label, 4 parallel arm study with a stratified randomization by sex (a quota for each sex [females and males] of at least 40% overall).
- Conditions
- Smoking, Tobacco Smoking, Tobacco Use
- Trial name
- NCT05599451
- Testing
- THS Blade device, THS Induction Mono device, THS Induction Mid device
- Where
- United Kingdom
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Healthy Volunteers
An Exploratory PET-study of Deposition, Disposition and Brain Uptake of [11C]Nicotine After Inhalation of 2 Nicotine Formulations Via the myBluTM E-cigarette in Smokers
This is a single-center, exploratory positron emission tomography (PET) study of deposition, disposition and brain uptake [11C]nicotine when given to smokers as two different formulations via mybluTM e-cigarette system.
- Trial name
- NCT04780815
- Testing
- myBluTM Formulation 1, myBluTM Formulation 2
- Where
- Sweden
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Imperial Brands PLC