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Evaluation of Short-term Safety and Use Patterns of an Electronic Nicotine Delivery System

Primary Purpose

Nicotine Dependence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NJOY King 26 mg nicotine Electronic Nicotine Delivery System
Sponsored by
LA Clinical Trials
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy cigarette smokers
  2. Not trying or planning to quit
  3. >10 factory-produced cigarettes/day for previous year
  4. Breath carbon monoxide level of >10 ppm at screening

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Abuse of drugs other than tobacco
  3. Use of any prescription psychoactive medications within 14 days
  4. Use of ENDS within 14 days
  5. Use of any nicotine replacement within 30 days

Sites / Locations

  • LA Clinical Trials

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NJOY King 26 mg nicotine Electronic Nicotine Delivery System

Arm Description

Outcomes

Primary Outcome Measures

Change in blood nicotine levels
Note: Visit 3 can occur up to 28 days after the Screening Visit
Change in average cigarettes smoked per day
Subjects will have a one weeks supply of NJOY Kings to use as they like. Mean cigarettes per day during the "actual use week" will be compared to the mean cigarettes per day for the baseline week (which is one week before the "actual use" week)
Average NJOY Kings puffs used per day
Mean number of puffs per day of NJOY King ENDS used during Day 1 through Day 6 of the actual use week which can begin 1 to 3 weeks after the Screening Visit

Secondary Outcome Measures

Full Information

First Posted
July 2, 2013
Last Updated
July 10, 2013
Sponsor
LA Clinical Trials
Collaborators
NJOY, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01898169
Brief Title
Evaluation of Short-term Safety and Use Patterns of an Electronic Nicotine Delivery System
Official Title
Evaluation of Plasma Nicotine, Carbon Monoxide, Heart Rate, Craving and Withdrawal After Acute Use of the NJOY King E-Cigarette in the Clinic, Following a One-Week Actual Use Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LA Clinical Trials
Collaborators
NJOY, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Electronic Nicotine Delivery Systems (ENDS), commonly referred to as electronic cigarettes have gained in popularity over the last several years. The technology used to manufacture ENDS has been evolving rapidly with a variety of delivery mechanisms, nicotine content, e-liquids and flavorings. Only in the last few years have researchers begun to examine the health risks and benefits, nicotine blood levels, patterns of use, likability, and craving and withdrawal relief of ENDS. These studies have shown great variability in nicotine delivery, effects on heart rate, and relief of craving or withdrawal among various ENDS brands among tobacco cigarette smokers. This study will test a new generation ENDS, the NJOY King Bold (NJOY, Scottsdale, AZ). It is a single use unit that resembles a traditional cigarette and delivers approximately 150 puffs. The cartridge inside contains 26 milligrams of nicotine. Our primary objective is to evaluate the short-term effects of using the NJOY Kings ENDS on heart rate, carbon monoxide and blood nicotine levels and well as on craving for cigarettes and nicotine withdrawal. Our secondary objective is to evaluate the subject's usage patterns for cigarettes and NJOY King ENDS during a one-week period in which they can use each freely. The study includes three visits to the clinic spaced approximately one week apart. Subjects who pass the screening visit will return to the clinic for Visit 2 in which they will sample the NJOY King ENDS for about 20 minutes before taking home enough to last till Visit 3, one week later. They will be instructed to use as many or as few as they like during the week. Subjects will keep a daily diary of number of tobacco cigarettes smoked and number of e-cigarette puffs taken. Subjects will return to the clinic for Visit 3 after 12 hours of abstinence from any form of nicotine in order to assure that they have no nicotine left in their bloodstream. Eligible subjects will then participate in two series of 10 puffs of NJOY Kings spaced one hour apart. During the 2.5 hours of the testing day, the following will be measured: 1) heart rate, 2) carbon monoxide, 3)blood will be sampled for nicotine levels, 4) craving for cigarettes and nicotine withdrawal symptoms will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NJOY King 26 mg nicotine Electronic Nicotine Delivery System
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
NJOY King 26 mg nicotine Electronic Nicotine Delivery System
Intervention Description
NJOY® King ENDS, menthol or nonmenthol, ad libitum use for 1 week NJOY® King ENDS, menthol or nonmenthol, 2 series of puffs, with a 30-second interpuff interval in each series and 1 hour between the first puff in each series.
Primary Outcome Measure Information:
Title
Change in blood nicotine levels
Description
Note: Visit 3 can occur up to 28 days after the Screening Visit
Time Frame
Change from baseline at Visit 3 to 5, 10, 15 and 30 minutes after each of two series, spaced one hour, apart of 10 puff from the NJOY King at Visit 3
Title
Change in average cigarettes smoked per day
Description
Subjects will have a one weeks supply of NJOY Kings to use as they like. Mean cigarettes per day during the "actual use week" will be compared to the mean cigarettes per day for the baseline week (which is one week before the "actual use" week)
Time Frame
The baseline week compared to the week testing the NJOY Kings in the "real world"
Title
Average NJOY Kings puffs used per day
Description
Mean number of puffs per day of NJOY King ENDS used during Day 1 through Day 6 of the actual use week which can begin 1 to 3 weeks after the Screening Visit
Time Frame
Day 1 through Day 6 of the of testing the NJOY Kings in the "real world"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy cigarette smokers Not trying or planning to quit >10 factory-produced cigarettes/day for previous year Breath carbon monoxide level of >10 ppm at screening Exclusion Criteria: Pregnancy or lactation Abuse of drugs other than tobacco Use of any prescription psychoactive medications within 14 days Use of ENDS within 14 days Use of any nicotine replacement within 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MITCHELL NIDES, Ph.D.
Organizational Affiliation
LA Clinical Trials
Official's Role
Principal Investigator
Facility Information:
Facility Name
LA Clinical Trials
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States

12. IPD Sharing Statement

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Evaluation of Short-term Safety and Use Patterns of an Electronic Nicotine Delivery System

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