Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Smoking
In brief
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.
Key facts
- Study ID
- NCT00932295
- Run by
- Virginia Commonwealth University
- People needed
- 32
- Starts
- 2009-02-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2016-12-13
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Clinical Behavioral Pharmacology Laboratory — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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