Clinical trials: Smoker
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
Carcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell
Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)
The primary objectives of the study are: To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell…
- Conditions
- Carcinoma，Non-Small-Cell Lung, Lung Carcinomas, Non-Small-Cell, Non-small-cell Lung Carcinoma, Nonsmall Cell Lung Cancer
- Trial name
- NCT03088540
- Testing
- Pemetrexed, Paclitaxel, Gemcitabine
- Where
- 192 sites in Australia, Belarus and 22 more
- Volunteers
- 712 people
- Sponsor
- Regeneron Pharmaceuticals
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
COPD
Chronic Obstructive Pulmonary Disease (COPD) Biomarker Identification Study
Chronic obstructive pulmonary disease (COPD) is a common inflammatory disease of the airway affecting approximately 10% of individuals aged 40 years or more with a smoking history.
- Trial name
- NCT01780298
- Where
- United Kingdom
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Smoking Cessation
A Single Dose-escalation Study of Cytisine in Adult Smokers
The objectives of this study are: 1. To assess the tolerability and safety of cytisine as a single oral dose. 2. To define the Cmax levels associated to the occurrence of dose-limiting adverse events.
- Trial name
- NCT03848208
- Testing
- cytisine
- Where
- Portugal
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Achieve Life Sciences
Smoking Cessation
A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers
This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline TID for treatment duration of 42 days/6 weeks and evaluate 3 mg cytisinicline TID for treatment duration of…
- Trial name
- ORCA-3 (NCT05206370)
- Testing
- Cytisinicline, Behavioral support
- Where
- 12 sites in United States
- Volunteers
- 792 people
- Sponsor
- Achieve Life Sciences
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
Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS 2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by Japanese adult healthy smokers results in a…
- Trial name
- NCT01970995
- Testing
- THS 2.2 Menthol (mTHS 2.2), Smoking Abstinence (SA), Menthol Conventional Cigarette (mCC)
- Where
- Japan
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Philip Morris Products S.A.
Smoking Cessation
Trial of Cytisine in Adult Smokers
This placebo-controlled Phase 2b trial is being conducted at sites within the United States (US) to evaluate the effectiveness cytisine dosage (1.5 mg, 3.0 mg) and administration schedule (commercial titration versus simplified 3…
- Trial name
- NCT03709823
- Testing
- Cytisine, Behavioral support
- Where
- 8 sites in United States
- Volunteers
- 254 people
- Sponsor
- Achieve Life Sciences
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
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.
Healthy
Clinical Trial to Assess Pharmacodynamic Effects on Segmental Endotoxin Induced Inflammatory Response of BI 1026706 Versus Placebo
The primary and secondary objectives of the current study are the assessments of anti-inflammatory pharmacodynamic effects on segmental endotoxin induced inflammatory response after 4 weeks treatment with BI 1026706.
- Trial name
- NCT02657408
- Testing
- BI 1026706
- Where
- Germany
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Respiratory Disorders
A Study to Test if a Third Dose of the Vaccine is Safe in Current and Former Smokers Aged 40 to 80 Years Old and to Gather Information on the Immune Response Following the Third Dose of the Vaccine
The purpose of this study is to test two different vaccine schedules to be used for administering the investigational NTHi Mcat vaccine that will be targeting patients with chronic obstructive pulmonary disease (COPD) to prevent…
- Trial name
- NCT03443427
- Testing
- NTHi Mcat investigational vaccine (GSK3277511A)
- Where
- 8 sites in Canada, Germany and 1 more
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Smoking Cessation
A Study of Cytisinicline for Smoking Cessation in Adult Smokers
This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline 3 times daily (TID) for treatment duration of 42 days/6 weeks and evaluate 3 mg cytisinicline TID for…
- Trial name
- ORCA-2 (NCT04576949)
- Testing
- Cytisinicline, Behavioral support
- Where
- 17 sites in United States
- Volunteers
- 810 people
- Sponsor
- Achieve Life Sciences
Smoking Cessation, Insurance Coverage
Impact Of Smoking Cessation Treatment Reimbursement On The Quit Rates In Smokers Motivated To Quit
This study is based on the hypothesis that access to smoking cessation treatment (SCT) reimbursement may significantly increase the number of successful quitters in a population of smokers motivated to quit by: 1) increasing the…
- Trial name
- ACCESSATION (NCT00818207)
- Testing
- Full Smoking Cessation Treatment Coverage (100%), No Smoking Cessation Treatment Coverage (0%)
- Where
- 56 sites in Canada
- Volunteers
- 1,380 people, healthy volunteers welcome
- Sponsor
- Pfizer
Tobacco Use Disorder
To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers
This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 4 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 4mg) in healthy smokers under fasting…
- Trial name
- NCT03543137
- Testing
- Nicotine Prototype Mini lozenge, Nicorette Mini Lozenge
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Non-Squamous Non-Small Cell Lung Cancer
A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
This randomized parallel group study will assess the efficacy and safety of erlotinib [Tarceva], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or…
- Trial name
- NCT01204697
- Testing
- docetaxel, erlotinib [Tarceva]
- Where
- 20 sites in Italy
- Volunteers
- 74 people
- Sponsor
- Hoffmann-La Roche
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
Smoking Cessation
Efficacy and Safety of Varenicline in Smokers With Cardiovascular Disease Who Wish to Quit Smoking
The primary purpose of this study is to determine whether or not varenicline will help people with cardiovascular disease quit smoking and to confirm it is safe in these patients.
- Trial name
- NCT00282984
- Testing
- Varenicline
- Where
- 39 sites in United States, Argentina and 13 more
- Volunteers
- 714 people
- Sponsor
- Pfizer
Smoking
A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers
Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an alternative supplier delivers the same nicotine blood profile as that of the currently approved NTS with a polyisobutylene adhesive from the…
- Trial name
- NCT01702519
- Testing
- nicotine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline