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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00932295
Enrollment
32
Registered
2009-07-03
Start date
2009-02-28
Completion date
2009-10-31
Last updated
2016-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Keywords

tobacco, cigarette, nicotine

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 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

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.

Interventions

OTHEROB

10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)

10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)

OTHERCROWN SEVEN

10 puffs from a so-called electronic cigarette named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)

OTHERNJOY

10 puffs from a so-called electronic cigarette named NJOY(16 mg cartridge; 30 second inter puff interval)

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Virginia Commonwealth University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frame
Plasma nicotine concentration (ng/ml)baseline, 5, 15, 30, and 45 minutes post-use

Secondary

MeasureTime frame
Heart ratecontinuous
Withdrawal suppression (subjective measure)baseline and 5, 15, 30, and 45 minutes post-use

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026