Clinical trials: Healthy Smokers
Healthy, Healthy Smoker
Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease
This is a 4-part, randomised, double-blind, placebo-controlled, first in human study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of inhaled RB042.
- Conditions
- Healthy, Healthy Smoker, COPD (Chronic Obstructive Pulmonary Disease), COPD
- Trial name
- NCT07285122
- Testing
- RB042
- Where
- Australia
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Atisama Therapeutics
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
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine.
- Trial name
- NCT01084603
- Testing
- Oral Nicotine, NiQuitinTM Nicotine Lozenge, Nicorette® Nicotine Gum
- Where
- Sweden
- Volunteers
- 45 people
- Sponsor
- McNeil AB
Healthy
Pharmacokinetic Study Evaluating Staccato® Alprazolam 1 mg Inhaler in Smokers Versus Non-Smokers
This is an open-label, non-randomized, single dose, pharmacokinetic study in 36 healthy adult male and female volunteers, including 18 smokers and 18 non-smokers.
- Trial name
- NCT03516305
- Testing
- Staccato Alprazolam 1 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Engage Therapeutics, Inc.
Smoking Cessation
A Study in Healthy Smokers to Investigate the Effect of Food on the Bioavailability of Cytisine in a New Formulation
This will be an open-label, randomised, 2-treatment period, single-dose crossover study to determine the comparative bioavailability and renal elimination following single-dose administration of 3.0 mg cytisine in healthy smokers…
- Trial name
- NCT03509948
- Testing
- cytisine
- Where
- United Kingdom
- Volunteers
- 13 people
- Sponsor
- Achieve Life Sciences
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
Healthy Smokers
Pilot Pharmacokinetic Study of New Nicotine Lozenge Formulations
The purpose of this study is to determine the pharmacokinetic profile of nicotine following a single oral administration of three new nicotine lozenge formulations (V0474) in comparison with two reference products.
- Trial name
- NCT01574898
- Testing
- V0474 - A mg, V0474 - B mg, V0474 - C mg
- Where
- France
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
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
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.
Thromboangiitis Obliterans (Buerger's Disease)
A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
This study is a first-in-human clinical trial of drug ATI-1013, in healthy adult cigarette smokers. The main questions it aims to answer are to learn about the safety of drug ATI-1013, how long drug ATI-1013 remains within the…
- Trial name
- NCT07215923
- Testing
- ATI-1013 (0.2 g), ATI-1013 (0.8 g), ATI-1013 (3.2 g)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Antidote Therapeutics, Inc
Smoking Cessation
Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge
A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.
- Trial name
- NCT01075659
- Testing
- Nicotine
- Where
- Sweden
- Volunteers
- 200 people
- Sponsor
- McNeil AB
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
Tobacco Dependence
A Study on the Effects of Two Nicotine Replacement Products on Tooth Staining
Participants will be smokers who want to quit, and have visible nicotine stains on their teeth. They will be given toothpaste and a toothbrush to use during the study, and will have an equal chance of being assigned to use either…
- Trial name
- NCT01440985
- Testing
- Nicotine
- Where
- Ireland
- Volunteers
- 200 people
- Sponsor
- McNeil AB
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.
COPD, Healthy Smoker
SLP Model Development in the Diagnosis of COPD Patients
This is an observational, comparative, multicentre study to develop a model for the Thora3Di™ against standard practice in patients who are undergoing investigation for COPD.
- Trial name
- SLPCOPD (NCT04584801)
- Testing
- Structured Light Plethysmography
- Where
- 7 sites in United Kingdom
- Volunteers
- 201 people, healthy volunteers welcome
- Sponsor
- Pneumacare Ltd
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
Smoking
Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.
The overall goal of the study is to demonstrate reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) identified in cigarettes and to obtain safety information…
- Trial name
- NCT02641587
- Testing
- CHTP 1.2, CC
- Where
- Poland
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Smoking Cessation
Study to Evaluate Effect of Food on Bioavailability of Single 3 mg Tablet and Pharmacokinetics (PK) of Multiple 3 mg Doses in Healthy Adult Smokers
To assess the effect of food on the bioavailability of 3 mg cytisinicline following single-dose administration, and to evaluate the PK profile of 3 mg cytisinicline TID following multiple days of administration during Days 5-8.
- Trial name
- NCT05981768
- Testing
- Cytisinicline
- Where
- Portugal
- Volunteers
- 30 people
- Sponsor
- Achieve Life Sciences
Smokers
Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers
The purpose of this study is to help smokers quitting by vaccinating them with CYT002-NicQb. Upon vaccination, the smoker will generate antibodies directed against free nicotine.
- Trial name
- NCT00369616
- Testing
- CYT002-NicQb
- Where
- 3 sites in Switzerland
- Volunteers
- 341 people
- Sponsor
- Cytos Biotechnology AG
Smoking, Nicotine
Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers
This is a single-center, randomized, controlled, open-label, cross-over study in healthy smoking subjects to investigate the nicotine pharmacokinetic (PK) profiles of 4 variants of Nicotine pouch 1.0 compared to marketed Velo …
- Trial name
- NCT05317195
- Testing
- NP-1, NP-2, NP-3
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.