Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02730676
Other study ID # CSD1503
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2016
Est. completion date August 2016

Study information

Verified date May 2018
Source R.J. Reynolds Vapor Company
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study assesses the nicotine pharmacokinetic (PK) parameters in adopters of electronic cigarettes following a 12-hour tobacco and nicotine abstinence. The PK results of this study will be compared to historical data on smokers obtained in prior studies, as well as on naïve and short-term users of electronic cigarettes.


Description:

This is an observational, open-label study to assess the nicotine pharmacokinetic (PK) parameters over a 6-hour period in adopters of electronic cigarettes with respect to an in-clinic 10-minute ad libitum period following a 12-hour tobacco and nicotine abstinence. In addition to PK parameters, subjective effects of urge for product will be assessed over a 6-hour period concurrently with the collection of the PK blood samples following a protocol defined schedule. The results of this study will be compared to historical PK and urge for product data obtained from smokers as well as naïve and short-term users of electronic cigarettes. In addition to the PK parameters and urge for product outcomes, plasma will be assessed for cotinine concentration prior to the 12-hour abstinence period.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria:

1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English;

2. Generally healthy males and females, 21 to 60 years of age, inclusive, at Screening Visit;

3. Breath expired carbon monoxide (ECO) level is <10 parts per million (ppm) at the Screening Visit and Visit Day 1;

4. Positive urine cotinine test at the Screening Visit and Visit Day 1;

5. Electronic cigarettes are the only form of tobacco- or nicotine-containing product used within 30 days of Screening;

6. Willing to use VUSE digital vapor cigarettes during the study according to protocol;

7. Willing to be confined overnight and abstain from tobacco- and nicotine-containing product use for 12 hours prior to investigational product use through Study Discharge;

8. Females of childbearing age must be willing to use a form of contraception acceptable to the Investigator from the time of signing the ICF until Study Discharge, or be surgically sterile for at least 90 days prior to the Screening Visit;

9. Ability to safely perform study procedures, as determined by the Investigator;

10. Group 1-specific inclusion criteria includes the following:

1. Currently uses VUSE Original digital vapor cigarettes;

2. Self-reports using VUSE Original digital vapor cigarettes at least once daily, for at least one month prior to the Screening Visit.

11. Group 2-specific inclusion criteria includes the following:

1. Currently uses VUSE Menthol digital vapor cigarettes;

2. Self-reports using VUSE Menthol digital vapor cigarettes at least once daily, for at least one month prior to the Screening Visit.

Exclusion Criteria:

1. Presence of clinically significant or unstable/uncontrolled acute or chronic medical conditions at the Screening Visit, as determined by the Investigator, that would preclude a subject from participating safely in the study (e.g., uncontrolled hypertension, asthma or other lung disease, cardiac disease, neurological disease, or psychiatric disorders) based on safety assessments such as clinical laboratory tests, medical history, and physical/oral examinations;

2. Self-reports or safety labs indicate diabetes;

3. At risk for heart disease, as determined by the Investigator;

4. Use of medicine for treatment of depression or asthma;

5. Systolic blood pressure of =150 mmHg or a diastolic blood pressure of =95 mmHg, measured after being seated for 5 minutes;

6. Hemoglobin level <12 g/dL at the Screening Visit;

7. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV);

8. History or presence of hemophilia or other bleeding disorders;

9. History or presence of clotting disorders with concomitant use of anticoagulants;

10. Given a whole blood donation in the 8 weeks (=56 days) prior to the Screening Visit;

11. Plasma donation within =7 days prior to the Screening Visit;

12. Body mass index <18.5 or >40.0 kg/m2 at the Screening Visit;

13. Weight of =110 pounds;

14. Poor peripheral venous access;

15. Postponing a decision to quit use of nicotine or tobacco products (defined as planning a quit attempt within 30 days of the Screening Visit) to participate in this study;

16. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to the Screening Visit;

17. Females who test positive for pregnancy, are pregnant or breastfeeding, or plan to become pregnant during the course of the study;

18. A positive urine drug screen without disclosure of corresponding concomitant medication(s) at the Screening Visit or on Visit Day 1;

19. A positive alcohol breathalyzer result at Screening or on Visit Day 1;

20. Self-reports drinking more than 14 servings of alcoholic beverages per week (1 serving = 12 oz. of beer, 6 oz. of wine, or 1 oz. of liquor);

21. Participation in another clinical trial within 30 days prior to the Screening Visit, as determined from the last visit of the prior trial to the first Screening Visit in this study;

22. Employed by a tobacco or nicotine company, the study site, or handled tobacco or nicotine products as part of your job.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Electronic Cigarette #1
VUSE® Digital Vapor Cigarettes (original flavor, 29 mg nicotine)
Electronic Cigarette #2
VUSE® Digital Vapor Cigarettes (menthol flavor, 29 mg nicotine)

Locations

Country Name City State
United States Davita Clinical Reserch Lakewood Colorado

Sponsors (3)

Lead Sponsor Collaborator
R.J. Reynolds Vapor Company Davita Clinical Research, RAI Services Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence Determine time to maximum plasma nicotine concentration (Tmax), baseline adjusted -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
Other Subjective effects scores for Urge for Product (UFP) with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence Score subjective effects using a numeric rating scale to determine area under the UFP score-versus-time curve (AUEC) -30, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes
Primary Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence Determine area under the plasma nicotine concentration versus time curve (AUC) -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
Primary Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product use following a 12-hour tobacco and nicotine abstinence Determine maximum plasma concentration (Cmax), baseline adjusted -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02649556 - A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 N/A
Completed NCT03901066 - Smoking Dependence and Periodontitis
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Completed NCT03305978 - Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan. N/A
Completed NCT00000437 - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) Phase 4
Completed NCT06105424 - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability N/A
Active, not recruiting NCT02752022 - Monitoring the Transition From Smoking to E-cigarettes
Completed NCT04340830 - The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants N/A
Completed NCT02901171 - The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation N/A
Completed NCT02912000 - TEACH: Technology Evaluation to Address Child Health N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02949648 - Electronic Cigarette Use and Quitting in Youth N/A
Completed NCT02246114 - Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT03448900 - Intervention Study for Smoking Cessation in Spanish College Students N/A
Completed NCT02008292 - Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors N/A
Completed NCT01898507 - Nicotine Metabolism and Low Nicotine Cigarettes N/A