Clinical trials: Healthy Smokers
Smoking
Nicotine Pharmacokinetic and Pharmacodynamics Profile, Safety and Tolerability of P3L
The purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD, i.e., subjective effects) profiles, and the safety and tolerability of the nicotine-containing aerosol delivered by Platform 3 Liquid…
- Trial name
- NCT02532374
- Testing
- Nicorette® inhalator, P3L
- Where
- New Zealand
- Volunteers
- 16 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
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
Smoking, Exercise Capacity
Effect of Switching From Cigarette Smoking to IQOS on Exercise Capacity
This exploratory study is part of the global clinical assessment program of IQOS. It was designed to provide scientific evidence to further substantiate the reduced risk potential of using a heated tobacco product (the Tobacco…
- Trial name
- NCT03887117
- Testing
- IQOS + Exercise Training Program, IQOS without Exercise Training Program, Cigarette Smoking + Exercise Training Program
- Where
- Germany
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
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.
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.
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
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
Respiratory Disorders
Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine
This study will provide information regarding the sequential administration of two vaccines adjuvanted with AS01. The aim of this study is to understand immunogenicity and safety of NTHi-Mcat vaccine when administered…
- Trial name
- NCT03894969
- Testing
- GSK's investigational non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) multi-antigen vaccine (GSK3277511A) adjuvanted with AS01E, Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine (GSK1437173A)
- Where
- 14 sites in Estonia, Finland and 3 more
- Volunteers
- 541 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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 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
Pharmacokinetics
Product Use and Adaptation, Safety and Tolerability of P3P in Adult Healthy Smokers Switching to it
The purpose of the study is to evaluate the product use and adaptation in adult, current cigarette smoking subjects between baseline and after one month of use of one of two P3P variants.
- Trial name
- NCT03953183
- Testing
- P3P-1mg, P3P-2mg
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
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
Healthy Volunteers
A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes
The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of combustible cigarettes to the…
- Trial name
- NCT04019626
- Testing
- Continue-smoking, myblu Tobacco 2.5%, myblu Tobacco 4.0%
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Fontem Ventures BV
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.
Cigarette Smoking
A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation
The purpose of this study was to understand the biological and functional changes after one year of smoking cessation and to collect data on a broad range of biomarkers of exposure (BoExp) and biomarkers of effect (BoE).
- Trial name
- RIBESC (NCT02432729)
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 1,184 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
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
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
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.