Clinical trials: Cigarette Smokers
Smoking
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
This is a randomized, controlled, open-label, 6 parallel arms study to assess reduced exposure of biomarkers of exposure (BoE) of selected HPHC in smokers switching to TP18 (a prototype heated tobacco device) or THS relative to…
- Trial name
- NCT07443631
- Testing
- THS1 (TP18 variant 1), THS2 (TP18 variant 2), THS3 (TP18 variant 3)
- Where
- United Kingdom
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Cigarette Smoking
Nicotine Pharmacokinetics From Research Electronic Nicotine Delivery System S-TA-U001 in Smokers and E-Cigarette Users
To better understand the PK and associated pharmacodynamic (PD) responses produced by the Research ENDS S-TA-U001 product, this study will compare the Research ENDS S-TA-U001 to The subject's own brand combustion (non-menthol)…
- Trial name
- NCT02792426
- Testing
- Research ENDS S-TA-U001, Nicorette Inhalator
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- NJOY, Inc.
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
Efficacy and Safety of Surinabant Treatment as an Aid to Smoking Cessation (SURSMOKE)
Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which might be clinically useful in the treatment of dependence to nicotine.
- Trial name
- NCT00432575
- Testing
- surinabant (SR147778)
- Where
- 8 sites in Belgium, France and 6 more
- Volunteers
- 810 people
- Sponsor
- Sanofi
Smoking Cessation, Vaping Cessation
Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers
Safety assessment of long-term 3 mg cytisinicline three times daily (TID) exposure for 52 weeks is the main purpose of this study, conducted in the United States.
- Trial name
- ORCA-OL (NCT06435221)
- Testing
- Cytisinicline
- Where
- 29 sites in United States
- Volunteers
- 479 people
- Sponsor
- Achieve Life Sciences
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
Periodontal Diseases, Chronic Periodontitis
Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome
The purpose of this study was to demonstrate in patients with generalized chronic periodontitis that switching from cigarette smoking to using IQOS improves the response to periodontal therapy and the overall oral health status…
- Conditions
- Periodontal Diseases, Chronic Periodontitis, Periodontal Pocket, Tooth Mobility
- Trial name
- NCT03364751
- Testing
- IQOS, Cigarette
- Where
- 26 sites in Japan
- Volunteers
- 179 people
- Sponsor
- Philip Morris Products S.A.
Smoking
Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting
Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a…
- Trial name
- NCT01989156
- Testing
- THS 2.2 Menthol (mTHS 2.2), Menthol Conventional Cigarette (mCC), Smoking Abstinence (SA)
- Where
- 2 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Healthy Volunteers
A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations
This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional…
- Trial name
- NCT03822546
- Testing
- Conventional cigarette, myblu 25 mg freebase, myblu 16 mg nicotine salt
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Fontem Ventures BV
Nicotine Dependence, Nicotine Dependence, Cigarettes
Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.
A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers
- Conditions
- Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
- Trial name
- NCT03700112
- Testing
- JUUL Virginia Tobacco flavored 5.0% ENDS, PMI iQOS Heat sticks, Reynolds VUSE Solo ENDS - Original
- Where
- New Zealand
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Juul Labs, Inc.
Healthy Volunteers
A Study to Evaluate Nicotine Uptake and Biomarkers in Adult 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
- NCT04429932
- Testing
- Myblu flavor A_2.4, Myblu flavor B_2.4, Myblu flavor C_2.4
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Fontem US LLC
Cardiovascular Disease, Cigarette Smoking
Cardiovascular Disease Biomarkers in Smokers and Moist Snuff Consumers
This cross-sectional study was primarily a cardiovascular disease (CVD) study designed a) to compare selected CVD biomarker data between subjects who were long-term consumers of cigarettes or moist snuff and non-consumers of…
- Trial name
- NCT01692353
- Testing
- Subject's usual brand (UB) tobacco product
- Where
- United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- R.J. Reynolds Tobacco Company
Smoking
Comparison of Pharmacokinetic Parameters Between Adopters of Electronic Cigarettes and a Historical Sample of Combustible Cigarette Smokers
This study assesses the nicotine pharmacokinetic (PK) parameters in adopters of electronic cigarettes following a 12-hour tobacco and nicotine abstinence.
- Trial name
- NCT02730676
- Testing
- Electronic Cigarette #1, Electronic Cigarette #2
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- R.J. Reynolds Vapor Company
Smoking, Non-smoking
Smoking Research Study
The purpose of this study is to develop a fit-for-purpose biochemical verification tool that can be used to detect concomitant use of a few (less than 5) conventional cigarettes.
- Trial name
- NCT01465880
- Testing
- Part A
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Smoking
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)
The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK…
- Trial name
- NCT01959607
- Testing
- THS 2.2, CC, NRT Gum
- Where
- Japan
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Smoking
Efficacy and Safety of Dianicline Versus Placebo as an Aid to Smoking Cessation
The primary objective is to demonstrate the efficacy of dianicline as an aid to smoking cessation in cigarette smokers. The main secondary objectives are: to assess the craving for cigarettes, nicotine withdrawal symptoms and the…
- Trial name
- EURODIAN (NCT00356967)
- Testing
- dianicline
- Where
- 6 sites in Belgium, Denmark and 4 more
- Volunteers
- 602 people
- Sponsor
- Sanofi
Tobacco Use
Evaluation of the Abuse Liability of Very Low Nicotine (VLN) Cigarettes
This study is designed to evaluate the abuse liability of very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes
- Trial name
- NCT03559751
- Testing
- VLN cigarettes (A), Usual Brand Cigarettes (B), Nicotine gum (C)
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- 22nd Century Group, Inc.
Tobacco Use
Pharmacokinetics and Comparative Bioavailability of Nicotine From Two Variants of NP2, NP2-4mg and NP2-6mg, Compared to Nicotine Lozenge 4mg (Loz-4mg) and Nicotine Gum 4mg (Gum-4mg)
This is a multi-center, randomized, controlled, partially blinded study to assess the pharmacokinetics and comparative bioavailability of nicotine from two variants of NP2 (4 and 6 mg) in comparison with Loz-4mg and Gum-4mg in…
- Trial name
- NCT06171490
- Testing
- NP2-4mg, NP2-6 mg, Loz-4mg
- Where
- 2 sites in Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Smoking, Healthy
Determination of Biomarkers of Exposure and Biomarkers of Potential Harm in Asian Adult Cigarette Smokers
The purpose of this study is to determine biomarkers of exposure to Harmful and Potentially Harmful Constituents (HPHCs) in Cigarette Smoke and cardiovascular-related biomarkers in smokers and non smokers.
- Trial name
- NCT02103751
- Where
- Japan
- Volunteers
- 1,069 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Smoking Behaviors, Smoking ( Cigarette)
A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products
This will be a randomized, open-label, 8-way crossover, single-site study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics [PD]), and plasma nicotine…
- Conditions
- Smoking Behaviors, Smoking ( Cigarette), Tobacco Use
- Trial name
- NCT07739797
- Testing
- Golden Tobacco Chill 5% (4) 6.5W, Glacier Menthol 5% (4) 6.5W, Fresh Mint 5% (4) 6.5W
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- RAI Services Company