Status:
COMPLETED
Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Smoking
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
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 mea...
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). Eval...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00932295
Start Date
February 1 2009
End Date
October 1 2009
Last Update
December 13 2016
Active Locations (1)
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1
Clinical Behavioral Pharmacology Laboratory
Richmond, Virginia, United States, 23298