Clinical trials: Healthy Smokers
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 Cessation
Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers
The purpose of this study is to evaluate the safety and pharmacodynamics of SEL-068. Increasing subcutaneous doses of SEL-068 will be administered to healthy non-smoker and smoker volunteers.
- Trial name
- NCT01478893
- Testing
- SEL-068, Saline
- Where
- Belgium
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Selecta Biosciences, Inc.
Tobacco Dependence
Bioequivalence Between Two Oral Nicotine Sublingual Tablets, 2 mg and 4 mg
The purpose of this study is to assess the bioequivalence between two oral nicotine sublingual tablets, 2 mg and 4 mg.
- Trial name
- NCT01238627
- Testing
- Nicotine Sublingual Tablet Mint (NSTM), Marketed Nicotine Tablet
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- McNeil AB
Pulmonary Disease, Chronic Obstructive
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2256294 in Healthy Volunteers, and Single and Repeat Doses of GSK2256294 in Adult Male Moderately Obese Smokers
This study is the First Time in Human Study for GSK2256294 and will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and repeat oral doses of GSK2256294 administered to healthy male…
- Trial name
- NCT01762774
- Testing
- GSK2256294
- Where
- United Kingdom
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Highly Dependant Smokers
Assessment of V0018 2.5 mg Effect on Craving
The purpose of this study is to evaluate the reduction of craving and its time course after administration of V0018 2.5 mg compared to placebo in healthy highly dependant smokers.
- Trial name
- NCT02357888
- Testing
- V0018
- Where
- France
- Volunteers
- 45 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.
Acute Inflammatory Response to Non-antigenic Stimulus
Phase 1a Study in Healthy Smokers to Investigate the Effect With MMI-0100 on Airway Inflammation in Induced Sputum After Challenge With Inhaled Lipopolysaccharide
A Phase 1a, randomized, placebo controlled, two-way crossover study is to determine the effect of inhaled MMI-0100 compared to placebo following LPS challenge on inflammatory markers.
- Trial name
- LPS (NCT02515396)
- Testing
- MMI-0100
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Moerae Matrix, Inc.
Healthy Subjects, Smokers
4 mg Nicotine Polacrilex Gum and Swedish Portion Snus
Fifteen healthy smokers are given single doses of General Onyx 1 g portion snus and General White 1g portion snus, respectively, and one piece of Nicorette 4 mg chewing gum.
- Trial name
- SMWS06 (NCT01182129)
- Testing
- Nicotine
- Where
- Sweden
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Contract Research Organization el AB
Mental Disorders
A Study to Examine the Pharmacodynamic Effects of GSK1034702 on Neurophysiological Biomarkers of Cognition in Nicotine Abstained Otherwise Healthy Smokers
This will be a double blind, randomised, placebo controlled, cross over study in which up to 20 otherwise healthy male nicotine abstinent smokers will be tested following 3 acute treatment conditions (placebo, 4 and 8mg of…
- Trial name
- MAA113746 (NCT01371799)
- Testing
- Drug
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Healthy Volunteers, Smoking
A Nicotine Pharmacokinetics and Smoking Behaviour Study Examining Cigarette Ingredients
This study will compare nicotine delivery and smoking behaviour in healthy subjects using several combustible cigarette prototypes containing different ingredients which are commonly used in the European Union.
- Trial name
- NCT03272295
- Testing
- Reference cigarette, Cigarette with carob bean extract, Cigarette with cocoa powder
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- British American Tobacco (Investments) Limited
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
Nicotine Dependence, Nicotine Dependence, Cigarettes
Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers
A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.
- Conditions
- Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
- Trial name
- NCT03593239
- Testing
- Tobacco flavored JUUL 1.7% ENDS, Tobacco flavored JUUL 5% ENDS, Mint flavored JUUL 1.7% ENDS
- Where
- New Zealand
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Juul Labs, Inc.
Smoking, Vaccines
A Study to Assess the Safety and Tolerability of Different Doses of PF-05402536 and PF-06413367 in Healthy Adult Smokers.
The purpose of this study is to determine the safety and tolerability of multiple doses of PF-05402536 and PF-06413367 in healthy adult smokers.
- Trial name
- NCT01672645
- Testing
- NIC7-001, NIC7-003, Saline
- Where
- 3 sites in Canada
- Volunteers
- 277 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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 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
Effects of EVT 302 With or Without NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes
This randomised, placebo-controlled study is designed to explore the effects of EVT 302 both with and without concomitant nicotine replacement therapy (NRT) on craving and withdrawal in smokers after short term deprivation of…
- Trial name
- NCT00622752
- Testing
- EVT 302, 10 mg, Nicotine replacement therapy (NRT)
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- Evotec Neurosciences GmbH
Tobacco Dependence
Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum
A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.
- Trial name
- NCT01368016
- Testing
- Nicotine
- Where
- 2 sites in Sweden
- Volunteers
- 346 people
- Sponsor
- McNeil AB
COPD, Asthma
Biomarker Assay Validation in Healthy Smokers and COPD Smokers and Ex-smokers
This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers to analyse biomarkers of inflammation
- Trial name
- NCT02490358
- Where
- United Kingdom
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Respivert Ltd