Cigarette Smoking Clinical Trial
Official title:
A Study to Evaluate the Comparative Pharmacokinetics of Nicotine After Administration Via Research Electronic Nicotine Delivery System S-TA-U001 in Healthy Volunteer Smokers and Current E-Cigarette Users
Verified date | May 2018 |
Source | NJOY, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To better understand the PK and associated pharmacodynamic (PD) responses produced by the
Research ENDS S-TA-U001 product, this study will compare the Research ENDS S-TA-U001 to
- The subject's own brand combustion (non-menthol) cigarette and a U.S. FDA approved
smoking cessation product, the NICORETTE Inhalator, in current non-menthol cigarette
smokers who have some limited e-cigarette experience (Group 1).
- Commercially available products in current primarily e-cigarette users (experienced ENDS
users) (Group 2) The PK/PD session for each product will be conducted in a controlled
clinical setting with frequent PK sampling after 14 hours of supervised abstinence from
all forms of nicotine. Subjects will familiarize themselves with the Research ENDS
S-TA-U001 and NICORETTE Inhalator by using each product in the real world for one day
before the PK/PD session for that product.
Primary Objectives:
Group 1 objectives are to characterize the nicotine PK profile (eg, maximum plasma
concentration [Cmax], time to maximum plasma concentration [Tmax], area under the
concentration-time curve [AUC], and terminal half-life [t1/2]) for 10 inhalation and ad lib
sessions of Research ENDS S-TA-U001 and explore how the Cmax compares to a 15 ng/mL level
during the 4.5-minute 10 inhalation and the 6 hour ad lib use sessions, to compare the PK
profiles between Research ENDS S-TA-U001 to the profiles of combustion cigarettes measured at
the baseline session, and to demonstrate superiority of PK profile of Research ENDS S-TA-U001
to that of the marketed NICORETTE Inhalator.
Group 2 objectives are to characterize the nicotine PK profile of Research ENDS S-TA-U001 and
explore how the Cmax compares to a 15 ng/mL level during the 4.5-minute 10 inhalation and 6
hour ad lib use sessions, and to compare the PK profile between Research ENDS S-TA-U001 to
the profile of a commercial ENDS product measured at the baseline session.
Secondary objectives:
Secondary objectives include comparison of the nicotine PK of the Research ENDS S-TA-U001 to
the subjects' normal nicotine source (combustion cigarettes for Group 1 or commercial ENDS
for Group 2), to evaluate the safety and tolerability of Research ENDS S-TA-U001, to evaluate
the effects on craving and user satisfaction of the Research ENDS S-TA-U001 vs a combustion
cigarette or the NICORETTE Inhalator (Group 1) or a commercial ENDS product (Group 2), and to
evaluate various biomarkers following use of each test product.
Status | Completed |
Enrollment | 34 |
Est. completion date | June 1, 2017 |
Est. primary completion date | June 1, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: For Group 1: in order to participate in the study, potential subjects must: 1. Be males and females of any race between 21 and 65 years of age inclusive 2. Be current combustion cigarette smokers, defined as smoking a minimum of 10 combustion cigarettes per day for a period of at least 3 months, who smoke commercial (non menthol) cigarettes 3. Not be currently planning to quit smoking combustion cigarettes in the next 3 months 4. Have blood cotinine =100 ng/mL and carbon monoxide =10 ppm at Screening to confirm smoking status 5. Weigh at least 45 kg and have a Body Mass Index (BMI) between 18 and 40 kg/m2, inclusive, at Screening 6. Be healthy, in the Investigator's opinion, according to medical history; physical examination; electrocardiogram (ECG); and clinical chemistry, urine, and hematological laboratory tests 7. Be willing to refrain from using any source of nicotine other than study supplies for the duration of the study confinement period 8. Have vital signs as follows: - Resting heart rate between 50 and 90 beats per minute - Systolic blood pressure below 150 mm Hg - Diastolic blood pressure below 90 mm Hg 9. Have electrolytes (ie, Na, K, Cl, HCO3) and hematocrit that are clinically normal (± 10% of laboratory limits); subjects marginally outside of this range may be eligible at the discretion of the study physician 10. Have liver function tests (ie, total bilirubin, ALT, AST, GGT, and alkaline phosphatase) less than three times the upper normal limit 11. Have kidney function tests (ie, creatinine and BUN) within clinically normal limits (± 10% of laboratory limits) and calculated creatinine clearance > 80 mL/min for females and > 90 mL/min for males 12. Have an ECG performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant abnormalities 13. Be able to demonstrate the ability to comply with the inhalation instructions for Test Product administration (Research ENDS S TA U001 and NICORETTE Inhalator), visually confirmed by clinic staff at Screening visit 14. Be able to verbalize understanding of the consent forms, provide written informed consent, and verbalize willingness to comply with the study procedure 15. Have 5-50 days of use of any ENDS product in their life and no use within 7 days before Screening 16. Have no more than 20 days of use of the NICOTROL Inhaler in their life and no use within the 7 days before Screening For Group 2: in order to participate in the study, potential subjects must: 1. Be males and females between 21 and 65 years of age inclusive 2. Be current daily users of a commercially available ENDS product, with e-liquids of nicotine concentration 10 to 20 mg/mL 3. Consume at least 1 mL per day of e-liquid in their ENDS product 4. Not smoke more than 2 combustion (non menthol) cigarettes per day 5. Have carbon monoxide =15 ppm at Screening to confirm limited smoking status 6. Have blood cotinine =100 ng/mL at Screening to confirm nicotine dependence 7. Weigh at least 45 kg and have a Body Mass Index (BMI) between 18 and 40 kg/m2, inclusive, at screening 8. Be healthy, in the Investigator's opinion, according to medical history; physical examination; ECG; and clinical chemistry, urine and hematological laboratory tests 9. Be willing to refrain from using any source of nicotine for the duration of the study confinement period 10. Have vital signs as follows: - Resting heart rate between 50 and 90 beats per minute - Systolic blood pressure below 150 mm Hg - Diastolic blood pressure below 90 mm Hg 11. Have electrolytes (ie, Na, K, Cl, HCO3) and hematocrit that are clinically normal (± 10% of laboratory limits); subjects marginally outside of this range may be eligible at the discretion of the study physician 12. Have liver function tests (ie, total bilirubin, ALT, AST, GGT, and alkaline phosphatase) less than three times the upper normal limit 13. Have kidney function tests (ie, creatinine and BUN) within clinically normal limits (± 10% of laboratory limits) and calculated creatinine clearance > 80 mL/min for females and > 90 mL/min for males 14. Have an ECG performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant abnormalities 15. Be able to demonstrate the ability to comply with the inhalation instructions for Test Product administration (Research ENDS S TA U001), visually confirmed by clinic staff at Screening visit 16. Be willing to use tobacco-flavored product 17. Be able to verbalize understanding of the consent forms, provide written informed consent, and verbalize willingness to comply with the study procedure Exclusion Criteria: For Group 1 and Group 2: in order to participate in the study, potential subjects must not: 1. Have expected inability to comply with study protocol 2. Have used any of the following in the past 30 days: ultra-light, hand or roll-your-own, menthol, or unfiltered combustion cigarettes; any other form of tobacco (eg, chews, dips, pipes, cigars, hookah); or any form of nicotine replacement therapy (eg, patch, gum, lozenge, inhaler, nasal spray). 3. Be pregnant (based on serum test) or nursing (by self-report) 4. Have history or diagnosis of airway disease, including adult onset asthma or chronic obstructive pulmonary disease (including emphysema or chronic bronchitis), use of an inhaler (apart from a nicotine inhaler) in the previous 5 years, or any episodes of wheezing or bronchospasm in the previous 5 years (history of resolved childhood asthma is acceptable) 5. Have baseline spirometry values (FEV1, FVC, and FEV1/FVC) outside of the lower limit of normal as defined by Hankinson et al, Am J Respir Crit Care Med 1999; 159:179-187. 6. Have had treatment with prescription medications within 21 days or over-the-counter medication within 24 hours of the planned first product use occasion, except for oral or hormonal contraceptive therapies. 7. Have used any drugs or substances (except tobacco) known to be strong inducers or inhibitors of any CYP enzymes (formerly known as cytochrome P450 enzymes) within a 28 days period prior to first product administration. For a list of such drugs and substances, please refer to http://medicine.iupui.edu/clinpharm/ddis/main-table/. 8. Have an active cough, recent or chronic, excluding "smoker's cough" 9. Have any active respiratory infection 10. Have a history of clinically significant cardiac, pulmonary, renal, hepatic, endocrine, neurological, gastrointestinal, metabolic, psychiatric, or hematologic disorders 11. Have poor venous access as defined by being unable to draw samples through a catheter at the screening visit 12. Have been hospitalized within 4 weeks before Screening 13. Have received any other investigational treatment or Test Product within 30 days from randomization (or within 5 half-lives of the Test Product, if known, whichever is greater) 14. Have a history of allergic, anaphylactic, or other hypersensitivity reaction to any e cigarette , or any of the components associated with these products such as propylene glycol 15. Have any medical history or condition (including physical) considered by the Principal Investigator and/or admitting physician to place the subjects at increased risk or preclude safe and/or successful completion of the study 16. Have any history of substance abuse, including alcohol abuse within the last 3 months 17. Have a positive result for any drug of abuse (opiates, benzodiazepines, barbiturates or related CNS depressants, amphetamines or related stimulants, or marijuana) at screening or Day -1 18. Be cognitively impaired to a degree that would affect participation. An adequate level of reading and comprehension is needed in order to complete various forms (e.g., behavioural assessments) that are used as dependent variables 19. Have active syphilis (based on the standard confirmatory test (e.g., FTB-abs)) 20. Be undergoing HIV treatment with antiviral and non-antiviral therapy or treatment for HIV-related opportunistic infection 21. Do not actively meet the inclusion criteria at the time of screening |
Country | Name | City | State |
---|---|---|---|
United States | LA Clinical Trials | Burbank | California |
Lead Sponsor | Collaborator |
---|---|
NJOY, Inc. | LA Clinical Trials, National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nicotine Cmax | Characterize nicotine Cmax of all test products during a 10-puff 4.5-minute session and a 6 hour ad lib use session and compare to a target level of 15 ng/mL | ~5 minutes before administration and at 1, 3, 5, 7, 10, 15, 30, 60, 90, 120, 130, 140, 150, 180, 210, 240, 300, 360, 420, and 480 minutes from start of each administration | |
Primary | Nicotine AUC | Characterize nicotine AUC from time 0 to the last time point for all test products | ~5 minutes before administration and at 1, 3, 5, 7, 10, 15, 30, 60, 90, 120, 130, 140, 150, 180, 210, 240, 300, 360, 420, and 480 minutes from start of each administration | |
Primary | Nicotine tmax | Characterize the time when the maximum nicotine concentration is reached for all test products during a 10-puff 4.5-minute session and a 6 hour ad lib use session | ~5 minutes before administration and at 1, 3, 5, 7, 10, 15, 30, 60, 90, 120, 130, 140, 150, 180, 210, 240, 300, 360, 420, and 480 minutes from start of each administration | |
Secondary | Adverse events and vital signs | To evaluate the safety and tolerability of Research ENDS S TA U001 during 4.5-minute 10 inhalation and 6 hour ad lib use sessions. Vital signs include respiratory rate, blood pressure, and oral temperature. | 5 days | |
Secondary | Effects on craving | To evaluate the effects on craving of the Research ENDS S TA U001 versus (vs) a combustion cigarette or the NICORETTE Inhalator (combustion cigarette users) or a commercial ENDS product (e cigarette users). A 5-item Questionnaire of Smoking Urges will be administered at -3, 2.75, 7, 20, 40, 65, 118, 125, 155, 185, 215, 275, 335, 395, and 455 minutes after the first puff of each test product administration. | 5 days | |
Secondary | Effects on user satisfaction | To evaluate the effects on user satisfaction of the Research ENDS S TA U001 versus (vs) a combustion cigarette or the NICORETTE Inhalator (combustion cigarette users) or a commercial ENDS product (e cigarette users). A likeability survey will be administered at the end of the in-clinic session for each test product | 5 days | |
Secondary | White blood cell count | Evaluation of white blood cell count | 5 days | |
Secondary | Carbon monoxide | Evaluation of carbon monoxide in exhaled breath | 5 days | |
Secondary | Spirometry | Evaluation of spirometry | 5 days |
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