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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Smoking

Intervention / Treatment
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* Other: OB
* Other: Sham smoking
* Other: CROWN SEVEN
* Other: NJOY


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Own brand cigarette<br>10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval) | Other: OB<br>* 10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)<br>|
| Sham Comparator: Sham smoking<br>10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval) | Other: Sham smoking<br>* 10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)<br>|
| Experimental: Electronic cigarette Version One C7<br>10 puffs from a so-called electronic cigarette named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval) | Other: CROWN SEVEN<br>* 10 puffs from a so-called electronic cigarette named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)<br>|
| Experimental: Electronic cigarette version 2: NJ<br>10 puffs from a so-called electronic cigarette named NJOY (16 mg cartridge; 30 second inter puff interval) | Other: NJOY<br>* 10 puffs from a so-called electronic cigarette named NJOY(16 mg cartridge; 30 second inter puff interval)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma nicotine concentration (ng/ml) |  | baseline, 5, 15, 30, and 45 minutes post-use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | continuous | 
| Withdrawal suppression (subjective measure) |  | baseline and 5, 15, 30, and 45 minutes post-use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco, cigarette, nicotine