Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.
December 12, 2016 updated by: Virginia Commonwealth University
The study's aim is to develop a clinical model that can be used to measure the nicotine delivery and tobacco/nicotine abstinence-suppressing capability of electronic devices that are marketed as a means to deliver nicotine to cigarette smokers.
The study will compare the nicotine delivery, cardiovascular effects, and tobacco withdrawal suppressing effects of two devices currently marketed in the U.S.: Crown Seven and NJOY.
Specifically, the effects of these devices will be compared with the effects of own brand cigarettes (positive control), and an abstinence condition (sham smoking; puffing from an unlit cigarette).
The primary hypothesis is that the nicotine delivery, withdrawal suppression, and other effects of electronic devices marketed as a means to deliver nicotine to smokers can be measured during a period of acute exposure.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Potential reduced exposure products (PREPs) are being developed and marketed by the tobacco industry in an attempt to reduce some of the risks involved in tobacco use (see Breland et al., 2002b).
Evaluating the effects of these products is crucial to public health, as past industry-sponsored efforts at harm reduction (e.g., so-called "light" and "ultra-light" cigarettes) were not evaluated and failed to reduce carbon monoxide (CO), nicotine, and carcinogen exposure in smokers; these efforts thus failed to reduce the harms of smoking (Stratton et al., 2001).
This study is part of an on-going, NIH-funded program of research to develop a science-based model that uses outcome measures relevant to evaluating current tobacco industry-sponsored smoking harm reduction efforts systematically and efficiently.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
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Richmond, Virginia, United States, 23298
- Clinical Behavioral Pharmacology Laboratory
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Participants must be healthy, between 18 and 55 years of age, and report a cigarette intake of > 15 cig/day for at least 1 year. They must provide an afternoon screening CO level of > 15 ppm at intake. They must also provide a urine sample for cotinine analysis, and receive a result of at least 4 on the urine immunoassay test strip scale (possible range = 0-6) at intake.
Exclusion Criteria:
Exclusion criteria include: history of chronic health problems or psychiatric conditions, breastfeeding, or pregnancy (assessed by urinalysis). Individuals who report current attempts to quit smoking, previous experience with Crown Seven or NJOY. Individuals who report alcohol or marijuana use greater than 20 days within the last 30 days, or recent illicit drug use such as cocaine or heroin. Women reporting active menopause will be excluded (menopause may cause tobacco/nicotine withdrawal-like symptoms, such as depression, Parry et al., 2001).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Own brand cigarette
10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)
|
10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)
|
|
Sham Comparator: Sham smoking
10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)
|
10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)
|
|
Experimental: Electronic cigarette Version One C7
10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)
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10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)
|
|
Experimental: Electronic cigarette version 2: NJ
10 puffs from a so-called "electronic cigarette" named NJOY (16 mg cartridge; 30 second inter puff interval)
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10 puffs from a so-called "electronic cigarette" named NJOY(16 mg cartridge; 30 second inter puff interval)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma nicotine concentration (ng/ml)
Time Frame: baseline, 5, 15, 30, and 45 minutes post-use
|
baseline, 5, 15, 30, and 45 minutes post-use
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Heart rate
Time Frame: continuous
|
continuous
|
|
Withdrawal suppression (subjective measure)
Time Frame: baseline and 5, 15, 30, and 45 minutes post-use
|
baseline and 5, 15, 30, and 45 minutes post-use
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Eissenberg, Ph.D., Virginia Commonwealth University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cobb CO, Weaver MF, Eissenberg T. Evaluating the acute effects of oral, non-combustible potential reduced exposure products marketed to smokers. Tob Control. 2010 Oct;19(5):367-73. doi: 10.1136/tc.2008.028993. Epub 2009 Apr 2.
- Gray JN, Breland AB, Weaver M, Eissenberg T. Potential reduced exposure products (PREPs) for smokeless tobacco users: clinical evaluation methodology. Nicotine Tob Res. 2008 Sep;10(9):1441-8. doi: 10.1080/14622200802323258.
- Blank MD, Sams C, Weaver MF, Eissenberg T. Nicotine delivery, cardiovascular profile, and subjective effects of an oral tobacco product for smokers. Nicotine Tob Res. 2008 Mar;10(3):417-21. doi: 10.1080/14622200801901880.
- Breland AB, Kleykamp BA, Eissenberg T. Clinical laboratory evaluation of potential reduced exposure products for smokers. Nicotine Tob Res. 2006 Dec;8(6):727-38. doi: 10.1080/14622200600789585.
- Breland AB, Evans SE, Buchhalter AR, Eissenberg T. Acute effects of Advance: a potential reduced exposure product for smokers. Tob Control. 2002 Dec;11(4):376-8. doi: 10.1136/tc.11.4.376.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
July 2, 2009
First Submitted That Met QC Criteria
July 2, 2009
First Posted (Estimate)
July 3, 2009
Study Record Updates
Last Update Posted (Estimate)
December 13, 2016
Last Update Submitted That Met QC Criteria
December 12, 2016
Last Verified
December 1, 2016
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.