Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 12/14/2016 |
| Start Date: | February 2009 |
| End Date: | October 2009 |
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.
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.
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.
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).
We found this trial at
1
site
Click here to add this to my saved trials
