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

Phase 1/Phase 2
18 Years
55 Years
Not Enrolling
No Conditions: This is Not a Treatment Study., Focus is on Cigarette Smokers.

Thank you

Trial Information

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

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.

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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Plasma nicotine concentration (ng/ml)

Outcome Time Frame:

baseline, 5, 15, 30, and 45 minutes post-use

Safety Issue:


Principal Investigator

Thomas Eissenberg, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University


United States: Federal Government

Study ID:




Start Date:

February 2009

Completion Date:

October 2009

Related Keywords:

  • No Conditions: This is Not a Treatment Study.
  • Focus is on Cigarette Smokers.
  • tobacco
  • cigarette
  • nicotine



Clinical Behavioral Pharmacology Laboratory Richmond, Virginia  23298