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| Study 1 of 5 for search of: | Electronic Cigarettes |
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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Collaborator: |
National Institute on Drug Abuse (NIDA) |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00932295 |
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 I Phase II |
| Study Type: | Interventional |
| Study Design: | Basic Science, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers. |
| 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 |
|---|---|
|
Own brand cigarette: Active Comparator
10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)
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Other: OB
10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)
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Sham smoking: Sham Comparator
10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)
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Other: Sham smoking
10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)
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Electronic cigarette Version One C7: Experimental
10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)
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Other: CROWN SEVEN
10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)
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Electronic cigarette version 2: NJ: Experimental
10 puffs from a so-called "electronic cigarette" named NJOY (16 mg cartridge; 30 second inter puff interval)
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Other: NJOY
10 puffs from a so-called "electronic cigarette" named NJOY(16 mg cartridge; 30 second inter puff interval)
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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 |
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| United States, Virginia | |
| Clinical Behavioral Pharmacology Laboratory | |
| Richmond, Virginia, United States, 23298 | |
| Principal Investigator: | Thomas Eissenberg, Ph.D. | Virginia Commonwealth University |
More Information
| Responsible Party: | Virginia Commonwealth University ( Thomas Eissenberg, Ph.D. Principal Investigator ) |
| Study ID Numbers: | HM11820, R01CA103827, R01CA120142 |
| Study First Received: | July 2, 2009 |
| Last Updated: | November 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00932295 History of Changes |
| Health Authority: | United States: Federal Government |
|
tobacco cigarette nicotine |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Autonomic Agents Nicotine Nicotinic Agonists |
Physiological Effects of Drugs Ganglionic Stimulants Peripheral Nervous System Agents Cholinergic Agents Pharmacologic Actions |
