Clinical trials: Nicotine
Tobacco Use
A Study to Evaluate Changes in Smokers Using An Oral Tobacco-Derived Nicotine Product
The purpose of this study was to estimate changes in biomarkers of exposure (BOE) in adult cigarette smokers using an oral tobacco-derived nicotine (OTDN) product relative to adult smokers who continue smoking exclusively.
- Trial name
- NCT04079933
- Testing
- Oral tobacco-derived nicotine product (OTDN)
- Where
- 3 sites in United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- Altria Client Services LLC
Smoking
User Acceptability of a Nicotine Lactate Delivery System (P3L)
This study will provide an initial assessment of the acceptability of the Nicotine Lactate Delivery System (P3L) after ad libitum use and the ability of combustible cigarette (CC) smokers to use P3L to maintain their customary…
- Trial name
- NCT02643693
- Testing
- P3L, VUSE, CC
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Impulse Control Disorders
Restoring Cognitive Control (ReCon) in Acute Nicotine Withdrawal
The purpose of this study is to explore the safety, tolerability and activity of SXC-2023 or placebo when dosed for 5 days in adults with tobacco use disorder who voluntarily abstain from the use of cigarettes.
- Trial name
- NCT03887429
- Testing
- SXC-2023
- Where
- 2 sites in United States
- Volunteers
- 34 people
- Sponsor
- Promentis Pharmaceuticals, Inc.
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.
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
Asthma
A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications
The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp…
- Trial name
- NCT01576718
- Testing
- Fp MDPI, Flovent Diskus, albuterol/salbutamol
- Where
- 300 sites in United States, Australia and 17 more
- Volunteers
- 889 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
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.
Smoking Cessation
Pharmacokinetic Study of 4 mg Nicotine Lozenge.
This is a randomized, single center, open label, single dose, four way crossover study in fasted healthy male subjects to compare the pharmacokinetics of nicotine following administration of 3 prototype 4mg nicotine lozenge to an…
- Trial name
- NCT01669122
- Testing
- nicotine
- Where
- India
- Volunteers
- 40 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 Dependence
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
The purpose of this study is to assess the efficacy and safety of a novel nicotine product for continuous abstinence from smoking.
- Trial name
- NCT02355665
- Testing
- Nicotine Spray
- Where
- 8 sites in United States
- Volunteers
- 1,198 people
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Smoking Cessation
Assessing Neuropsychiatric Symptoms Including Depression, Anxiety, Irritability, and Suicidal Thoughts or Behavior in Subjects Quitting Smoking on Varenicline Tartrate or Placebo
Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.
- Trial name
- NCT00749944
- Testing
- varenicline
- Where
- 2 sites in United States
- Volunteers
- 110 people
- Sponsor
- Pfizer
Healthy Volunteers
A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
This is a randomised, cross-over, open-label, confinement study conducted in 24 adult male or female smokers of combustible cigarettes.
- Trial name
- NCT05459857
- Testing
- Product A, Product B, Product C
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Imperial Brands PLC
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
Thoracic Aortic Aneurysms
Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)
The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market approval.
- Trial name
- THRIVE (NCT00805948)
- Testing
- Talent Thoracic Stent Graft System
- Where
- 26 sites in United States
- Volunteers
- 349 people
- Sponsor
- Medtronic Cardiovascular
Smoking Cessation
Nicotine Mouth Film for Craving Relief.
Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in…
- Trial name
- NCT01702532
- Testing
- Nicotine
- Where
- 2 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tobacco Use
Pharmacokinetic and Subjective Effects of Heated Tobacco Products
This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK (pharmacokinetic) and subjective effects of HTPs (Heated Tobacco Products) comprised of 2 menthol varieties and 2 tobacco flavor…
- Trial name
- NCT06356610
- Testing
- Product A, Product B, Product C
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- Altria Client Services LLC
Smoking, Tobacco
Nicotine Pharmacokinetics of THS Single Use of a Regular or a Menthol Stick Compared to CIG
The purpose of this study was to describe the nicotine pharmacokinetic (PK) profile during and after single use of THS (Induction heating technology, with either a regular or menthol stick) compared to singular CIG smoking in…
- Trial name
- NCT05789420
- Testing
- P1R stick, P1M stick, CIG
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Tobacco Use
Study to Evaluate Changes in Smokers Using on!® Nicotine Pouches
The purpose of this study is to generate evidence regarding the extent of reduction in exposure to selected HPHCs in adult smokers switching to on!® NPs.
- Trial name
- NCT05664672
- Testing
- OTDN Product 1, OTDN Product 2, OTDN Product 3
- Where
- 3 sites in United States
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Altria Client Services LLC
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 Cessation
Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
The primary objective of this study is to compare pharmacokinetic (PK) profiles and assess the bioequivalence between the newly developed nicotine gums (2 mg and 4 mg) and the reference nicotine gums (2 mg and 4 mg) in healthy…
- Trial name
- NCT01847443
- Testing
- Nicotine (2 mg), Nicotine (4 mg)
- Where
- United Kingdom
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline