Cigarette Smoking Clinical Trial
Official title:
A Proof-of-Concept Study to Characterize Biomarkers of Tobacco Exposure, Product Use, and Urge-to-Smoke Following Short-Term Exclusive and Dual Ad Lib Use of Electronic Cigarettes in a Controlled Clinical Setting
Verified date | March 2015 |
Source | Lorillard Tobacco Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, open-label, forced-switch, parallel, proof-of-concept study to assess
exposure to biomarkers of tobacco exposure following short-term ad lib use of three blu
e-cigarette products. The primary objectives of this study are to:
1. Compare changes in selected urine and blood biomarkers of tobacco exposure within
cohorts following a 5-day forced-switch from usual brand conventional combustible
cigarettes to exclusive use of blu e-cigarettes, dual use of blu e cigarettes and the
subject's usual brand combustible cigarette, or smoking cessation.
2. Compare changes in selected urine and blood biomarkers of tobacco exposure among cohorts
following a 5-day forced-switch from usual brand conventional combustible cigarettes to
exclusive use of a blu e cigarette, dual use of a blu e-cigarette and the subject's
usual brand combustible cigarette, or smoking cessation.
The secondary objectives of this study are to:
1. Compare changes in selected physiological endpoints affected by tobacco exposure within
cohorts during a 5-day forced-switch from usual brand conventional combustible
cigarettes to exclusive use of blu e cigarettes, dual use of blu e cigarettes and the
subject's usual brand combustible cigarette, or smoking cessation.
2. Compare changes in selected physiological endpoints affected by tobacco exposure among
cohorts following a forced-switch to exclusive use of a blu e cigarette, dual use of a
blu e-cigarette and the subject's usual brand combustible cigarette, or smoking
cessation.
3. Determine daily nicotine consumption from blu e-cigarettes following exclusive use of
blu e cigarettes or dual use of blu e-cigarettes and the subject's usual brand
combustible cigarette over a 5-day period.
4. Assess the effectiveness of exclusive use of blu e-cigarettes or dual use of blu
e-cigarettes and the subject's usual brand combustible cigarette to reduce the urge to
smoke.
5. Assess subject opinions of various characteristics of blu e-cigarettes.
6. Assess the safety and tolerability of short-term use of blu e-cigarettes.
Status | Completed |
Enrollment | 105 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Healthy adult male and female smokers, 21 to 65 years of age, inclusive, at Screening. 2. Combustible cigarette smoker for at least 12 months prior to Check-in. Brief periods of non-smoking during the 90 to 14 days prior to Check-in (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) will be permitted at the discretion of the Investigator. 3. Currently smokes an average of 10 or more king size (~83 - 85 mm) or 100s (~98 - 100 mm) manufactured combustible cigarettes per day (any brand style). 4. Consistent use of a single brand style for 14 days prior to Check-in. 5. Positive urine cotinine at Screening (= 500 ng/mL). 6. Exhaled CO > 12 ppm at Screening. 7. Female subjects of non-childbearing potential and of childbearing potential will be eligible. Examples of acceptable forms of contraception include, but are not limited to, the following. - Surgeries:Hysterectomy at least 6 months prior to product administration; Oophorectomy at least 6 months prior to product administration; Tubal ligation at least 6 months prior to product administration - Transcervical sterilization at least 6 months prior to product administration - Hormonal birth control at least 3 months prior to product administration - Non-hormonal intrauterine device at least 3 months prior to product administration - Double barrier methods (e.g., condom and spermicide) at least 14 days prior to product administration - Abstinence at least 14 days prior to product administration - Vasectomized partner is acceptable birth control for females provided the surgery was performed at least 6 months prior to product administration - Postmenopausal at least 1 year prior to product administration and confirmed by follicle stimulating hormone (FSH) test at Screening. 8. Understands the study procedures and provides voluntary consent to participate in the study documented on the signed ICF. 9. Willing to comply with the study requirements, including potential use of any study product or smoking cessation during the study. Exclusion Criteria: 1. History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary (especially bronchospastic diseases), immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results. 2. Clinically significant abnormal findings on the physical examination, medical history, ECG, or clinical laboratory results at Screening or Check-in, in the opinion of the Investigator. 3. Positive test for HIV, HbsAg, or HCV. 4. An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 2 weeks prior to Check-in. 5. Fever (>100.2F) at Screening or at Check-in. 6. Systolic blood pressure >150 mmHg, diastolic blood pressure >95 mmHg, or pulse rate >99 bpm at Screening. 7. BMI <18 kg/m2 or >40 kg/m2 at Screening. 8. Female subjects who are pregnant, lactating, or intend to become pregnant from Screening through completion of study. 9. Use of prescription anti-diabetic medication and/or insulin therapy within 12 months of Check-in. 10. Use of medications or foods known or are suspected to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disullfiram, entacapone, fenofibrate, isoniazid, grapefruit, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital, selegiline, sulconazole, tioconazole, tranylcypromine,) within 14 days or five half-lives of the drug, whichever is longer, prior to Check-in. 11. Use of inhalers to treat any medical condition within 3 months prior to Check-in and throughout the study. 12. Positive urine screen for alcohol or drugs of abuse at Screening or at Check-in. 13. History of drug or alcohol abuse within 24 months prior to Check-in. 14. Plasma donation within 7 days prior to Check-in. 15. Donation of blood or blood products, had significant blood loss, or received whole blood or a blood product transfusion within 56 days prior to Check-in. 16. Participation in a previous clinical study for an investigational drug, biologic, medical device, or tobacco product within 28 days prior to Check-in. 17. Use of tobacco or nicotine-containing products (e.g., roll-your-own cigarettes, bidis, snuff, snus, tablets, inhalers, pipes, cigars, chewing tobacco, nicotine replacement therapies [e.g., gum, patches, lozenges, nasal spray, or inhalers]) other than manufactured cigarettes or e-cigarettes within 28 days prior to Check-in. 18. Use of any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix) or buproprion (Zyban) within 3 months prior to Check-in. 19. Known hypersensitivity to the study products, glycerol, or propylene glycol. 20. Self-reported puffers (i.e., smokers who draw smoke from the cigarette into the mouth and throat but do not inhale). 21. Subject or a first-degree relative (i.e., parent, sibling, child) is a current or former employee of the tobacco industry or a named party or class representative in litigation with the tobacco industry. |
Country | Name | City | State |
---|---|---|---|
United States | Celerion | Lincoln | Nebraska |
Lead Sponsor | Collaborator |
---|---|
Lorillard Tobacco Company | Celerion |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biomarkers of tobacco exposure as measured in urine | Excretion of each urine biomarker of exposure (NNAL, nicotine equivalents, 3-HPMA, HMPMA, CEMA, 1-OH pyrene, NNN, MHBMA, and S-PMA) will be assessed at baseline and following a 5-day forced switch to determine changes associated with product use or cessation, and differences between cohorts. | 5 days | |
Primary | Biomarkers of tobacco effect as measured in urine | Excretion of F2-isoprostane (8-iso-PGF2 Type III) will be assessed at baseline and following a 5-day forced switch to determine changes associated with product use or cessation, and differences between cohorts. | 5 days | |
Primary | Biomarkers of tobacco exposure as measured in blood | Exposure to each blood biomarker of exposure (COHb, nicotine, cotinine, and trans-3'hydroxycotinine) will be assessed at baseline and during a 5-day forced switch to determine changes associated with product use or cessation, and differences between cohorts. | 5 days | |
Secondary | Daily product consumption as measured by e-cigarette and combustible cigarette use | Daily nicotine consumption from blu e-cigarettes and the number of cigarettes smoked per day will be assessed at baseline and during a 5-day forced switch to determine changes associated with product use and differences between cohorts. | 5 days | |
Secondary | Urge to smoke as measured by visual analog scale | The urge to smoke will be assessed at baseline and during a 5-day forced switch to determine the effectiveness of blu e-cigarettes to determine changes associated with product use or cessation, and differences between cohorts. | 5 days | |
Secondary | Physiologic effects as measured by spirometry | FVC and FEV1 will be assessed at baseline and during a 5-day forced switch to determine changes associated with product use or cessation, and differences between cohorts. | 5 days | |
Secondary | Physiologic effects as measured by exhaled breath | Exhaled CO and NO will be assessed at baseline and during a 5-day forced switch to determine changes associated with product use or cessation, and differences between cohorts. | 5 days | |
Secondary | Physiologic effects as measured by blood pressure and pulse rate | Sytolic and diastolic blood pressure and heart rate will be assessed at baseline and during a 5-day forced switch to determine changes associated with product use or cessation, and differences between cohorts. | 5 days | |
Secondary | Relationship between product use and biomarker exposure | The relationship between product use and exposure to the urine and blood biomarkers of tobacco exposure and effect will be assessed. | 5 days | |
Secondary | Subjective product assessments as measured by the modified cigarette evaluation scale | The Modified Cigarette Evaluation Scale will be administered to assess differences in subjective opinions of the blu e-cigarettes between cohorts. | 5 days | |
Secondary | Safety and tolerability as measured by number of subjects with adverse events or changes in health status | The safety and tolerability of blu e-cigarettes during a 5-day period of use will be assessed using physical examinations, vital signs, clinical laboratory assessments, and adverse event and concomitant medication monitoring. | 5 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Active, not recruiting |
NCT02643914 -
Control Systems Approach to Predicting Individualized Dynamics of Nicotine Cravings
|
N/A | |
Recruiting |
NCT02422914 -
Benefits of Tobacco Free Cigarette
|
N/A | |
Active, not recruiting |
NCT02629679 -
Sports, Education and Consumption of Substances in Adolescents
|
N/A | |
Completed |
NCT02218281 -
Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation
|
N/A | |
Completed |
NCT01199380 -
Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms
|
Phase 2 | |
Completed |
NCT00802919 -
Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors
|
Phase 4 | |
Completed |
NCT01692353 -
Cardiovascular Disease Biomarkers in Smokers and Moist Snuff Consumers
|
N/A | |
Completed |
NCT00756704 -
The Effectiveness of Smoking Cessation Guidelines in the Emergency Department
|
N/A | |
Completed |
NCT01081119 -
Brief Voluntary Alcohol and Drug Intervention for Middle School Youth
|
Phase 2 | |
Completed |
NCT00682474 -
School Nurse-Delivered Smoking Cessation Intervention
|
Phase 2/Phase 3 | |
Completed |
NCT05520775 -
Semaglutide for Alcohol Use Disorder
|
Phase 2 | |
Completed |
NCT03743532 -
E-Cigarettes and Financial Incentives to Promote Tobacco Harm Reduction Among Adults Accessing Shelter Services
|
N/A | |
Terminated |
NCT03840694 -
Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior
|
N/A | |
Completed |
NCT06032793 -
Effects of Deep Breathing Exercise on Pulmonary Function, Perceived Stress and Physical Fitness.
|
N/A | |
Terminated |
NCT03326128 -
High Dose Bupropion for Smoking Cessation - Pilot Study
|
Phase 2 | |
Recruiting |
NCT03218670 -
Your Health in On Click
|
N/A | |
Completed |
NCT02538042 -
Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)
|
N/A | |
Completed |
NCT02792426 -
Nicotine Pharmacokinetics From Research Electronic Nicotine Delivery System S-TA-U001 in Smokers and E-Cigarette Users
|
Phase 1 |