Clinical trials: Nicotine Use
Smoking, Smoking Behaviors
Abuse Liability for Eight Electronic Nicotine 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, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Trial name
- NCT07323511
- Testing
- Product A, Product B, Product C
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- RAI Services Company
Smoking, Tobacco Use
CSD201301: Study to Assess Elements of Abuse Liability for Four P13 Nicotine Pouches
This is a two-site, open-label, randomized, 6-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics [PD]) and plasma nicotine uptake…
- Conditions
- Smoking, Tobacco Use, Tobacco Smoking
- Trial name
- NCT05294497
- Testing
- Product A, Product B, Product C
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- RAI Services Company
Smoking, Tobacco Use Disorder
A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers
A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke
- Trial name
- NCT01262170
- Testing
- CigRx Lozenge, Tobacco Lozenge
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Rock Creek Pharmaceuticals, Inc.
Nicotine Use Disorder
Study to Assess PK, PD, Nicotine Extraction, Palatability, Subjective Effects of Nicotine Pouches - Daily Nicotine Users
This is an explorative, open-label, randomised, 3-way cross-over study to assess pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability, nicotine extraction, palatability and subjective effects after single use of…
- Trial name
- NCT06170138
- Testing
- Test product 1 - Test product 2 - Comparator product
- Where
- Sweden
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Amplicon AB
Smoking, Tobacco Use
CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products
This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) study, designed to evaluate elements of abuse liability (AL) including subjective…
- Conditions
- Smoking, Tobacco Use, Tobacco Smoking
- Trial name
- NCT04167384
- Testing
- Product A, Product B, Product C
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- RAI Services Company
Tobacco Use
A Study to Assess Changes in Cigarette Consumption During a Switch to Very Low Nicotine Cigarettes
This study evaluates the impact of switching from usual brand cigarettes to very low nicotine cigarettes on cigarette consumption, smoking behavior, and biomarkers of exposure.
- Trial name
- NCT03571724
- Testing
- Non-Menthol Very Low Nicotine Cigarettes, Menthol Very Low Nicotine Cigarettes, Subject's UB non-mentholated filtered cigarettes
- Where
- 2 sites in United States
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- 22nd Century Group, Inc.
Tobacco Use
Evaluation of Abuse Liability of Very Low Nicotine (VLN) Mentholated Cigarettes
This study is designed to evaluate the abuse liability of mentholated very low nicotine cigarettes compared to nicotine gum and usual brand cigarettes.
- Trial name
- NCT03559725
- Testing
- VLN menthol cigarettes (A), Usual Brand Menthol Cigarettes (B), Nicotine gum (C)
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- 22nd Century Group, Inc.
Nicotine Addiction, Cigarette Smoking
Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use
Three hundred-twenty (320) adult smokers of menthol or non-menthol combustible cigarettes will be recruited and randomly assigned to one of five groups (n=64/group), who will be asked to switch for 12 weeks to ad libitum use of…
- Trial name
- DUAL (NCT02870218)
- Testing
- Smoking research cigarettes with e-cigarette, Nicotine discrimination thresholds
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Rose Research Center, LLC
Smoking, Smoking Behaviors
A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems
This will be an open-label, randomized, single-site, 8-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters and overall product liking (OPL) following an ad libitum use of Electronic Nicotine…
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Trial name
- NCT07323563
- Testing
- Product A, Product B, Product C
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- RAI Services Company
Tobacco Use
A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.
The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to…
- Trial name
- NCT03692078
- Testing
- OTDN product 1, OTDN product 2, Tobacco Cessation
- Where
- 2 sites in United States
- Volunteers
- 231 people, healthy volunteers welcome
- Sponsor
- Altria Client Services LLC
Smoking, Tobacco Use
CSD201004: An Actual Use Study of P10 and P13 Nicotine Pouches Among U.S. Adult Smokers
The purpose of this Actual Use Study (AUS) is to investigate how U.S. adult tobacco consumers 21-60 years of age) who are regular smokers (≥5 cigarettes/day) on at least 20 days out of the past 30 days will use P10 and P13…
- Conditions
- Smoking, Tobacco Use, Tobacco Smoking
- Trial name
- NCT05184920
- Testing
- P1012919 nicotine pouch, P1012915 nicotine pouch, P1012914 nicotine pouch
- Where
- 10 sites in United States
- Volunteers
- 1,105 people, healthy volunteers welcome
- Sponsor
- RAI Services Company
Smoking, Smoking Behaviors
CSD190601: A Study to Determine Subject Puffing Patterns of Electronic Nicotine Delivery Systems in an Ambulatory Setting
This study will be a single-center, controlled, open-label, parallel two-study-group investigation to evaluate the puffing patterns of healthy adult consumers of tobacco products switching from a usual brand (UB) Electronic…
- Conditions
- Smoking, Smoking Behaviors, Tobacco Use, Tobacco Smoking
- Trial name
- NCT04308434
- Testing
- CSD190601-11, CSD190601-12, CSD190601-13
- Where
- United States
- Volunteers
- 107 people, healthy volunteers welcome
- Sponsor
- RAI Services Company
Smoking, Tobacco Product
Japanese Post-Market Cohort Study
The objectives and endpoints of this study were analyzed in the study population of adults eligible to purchase tobacco products.
- Trial name
- NCT03020667
- Where
- Japan
- Volunteers
- 1,124 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Nicotine Dependence, Nicotine Dependence, Cigarettes
United States Pre-Market Tobacco Application Pharmacokinetics
A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator…
- Conditions
- Nicotine Dependence, Nicotine Dependence, Cigarettes, Tobacco Use, Tobacco Smoking
- Trial name
- US-PMTA-PK (NCT03719391)
- Testing
- Virginia Tobacco flavored JUUL 5% ENDS, Cool Mint flavored JUUL 5% ENDS, Mango flavored JUUL 5% ENDS
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Juul Labs, Inc.
Tobacco Dependence
A Bioequivalence Study Between Two Nicotine Replacement Therapies in Adult Healthy Smokers Motivated to Quit.
This is a research study to verify the same effectiveness and safety profile for the test product, Nicorette Strongmint lozenge, as for an already approved product, NiQuitin® Minimint lozenge (reference product), in a…
- Trial name
- NCT03130179
- Testing
- Nicorette Strongmint lozenge 4 mg, Niquitin MiniMint lozenge 4 mg
- Where
- Russia
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- McNeil AB
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 Cessation, Harm Reduction
In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Swedish 'Snus' in Regular Snus Users
In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini".
- Trial name
- SMWS03 (NCT01838473)
- Testing
- Buccal Administration of nicotine
- Where
- Sweden
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Contract Research Organization el AB
Smoking
Characterization of Nicotine Exposure and Urge-to-Smoke Following Use of Electronic and Conventional Cigarettes
This trial was the initial characterization of the blu™ products being studied, with the purpose of gaining an understanding of the exposure to nicotine and craving reduction attained following use of blu™ e-cigarettes by adult…
- Trial name
- NCT02210754
- Testing
- blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle), blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle), blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Lorillard Tobacco Company
Smoking, Tobacco
CSD201204 An Actual Use Study of P12 Electronic Nicotine Delivery System Among U.S. Adult Smokers
The purpose of this Actual Use Study (AUS) is to investigate how United States (US) adult tobacco consumers 21 to 60 years of age, inclusive, who are regular smokers (≥5 cigarettes/day on at least 20 of the past 30 days) will use…
- Trial name
- NCT05960305
- Testing
- P1213416, P1213422, P1213716
- Where
- 12 sites in United States
- Volunteers
- 1,845 people, healthy volunteers welcome
- Sponsor
- RAI Services Company
Smoking Cessation, Harm Reduction
Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders
To determine whether smokers who initially respond (within 2 weeks) to nicotine products (including nicotine replacement therapy, e-cigarettes, nicotine pouches) by reducing their smoking by ≥50% can be successfully maintained on…
- Trial name
- NCT06554873
- Testing
- Nicoderm, Nicorette 4Mg Chewing Gum, Nicorette Lozenge Product
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Rose Research Center, LLC