Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00932295
First received: July 2, 2009
Last updated: October 20, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
No Conditions: This is Not a Treatment Study.
Focus is on Cigarette Smokers.
Other: OB
Other: Sham smoking
Other: CROWN SEVEN
Other: NJOY
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Plasma nicotine concentration (ng/ml) [ Time Frame: baseline, 5, 15, 30, and 45 minutes post-use ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heart rate [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • Withdrawal suppression (subjective measure) [ Time Frame: baseline and 5, 15, 30, and 45 minutes post-use ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Own brand cigarette
10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)
Other: OB
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)
Other: Sham smoking
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)
Other: CROWN SEVEN
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)
Other: NJOY
10 puffs from a so-called "electronic cigarette" named NJOY(16 mg cartridge; 30 second inter puff interval)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932295

Locations
United States, Virginia
Clinical Behavioral Pharmacology Laboratory
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Thomas Eissenberg, Ph.D. Virginia Commonwealth University
  More Information

Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00932295     History of Changes
Other Study ID Numbers: HM11820, R01CA103827, R01CA120142
Study First Received: July 2, 2009
Last Updated: October 20, 2011
Health Authority: United States: Federal Government

Keywords provided by Virginia Commonwealth University:
tobacco
cigarette
nicotine

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014