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

NCT ID: NCT00932295

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-10-31

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.

Conditions

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Smoking

Keywords

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tobacco cigarette nicotine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Own brand cigarette

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

Group Type ACTIVE_COMPARATOR

OB

Intervention Type OTHER

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

Sham smoking

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

Group Type SHAM_COMPARATOR

Sham smoking

Intervention Type OTHER

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

Electronic cigarette Version One C7

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

Group Type EXPERIMENTAL

CROWN SEVEN

Intervention Type OTHER

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

Electronic cigarette version 2: NJ

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

Group Type EXPERIMENTAL

NJOY

Intervention Type OTHER

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

Interventions

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OB

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

Intervention Type OTHER

Sham smoking

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

Intervention Type OTHER

CROWN SEVEN

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

Intervention Type OTHER

NJOY

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

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Eissenberg, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Clinical Behavioral Pharmacology Laboratory

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Cobb CO, Weaver MF, Eissenberg T. Evaluating the acute effects of oral, non-combustible potential reduced exposure products marketed to smokers. Tob Control. 2010 Oct;19(5):367-73. doi: 10.1136/tc.2008.028993. Epub 2009 Apr 2.

Reference Type BACKGROUND
PMID: 19346218 (View on PubMed)

Gray JN, Breland AB, Weaver M, Eissenberg T. Potential reduced exposure products (PREPs) for smokeless tobacco users: clinical evaluation methodology. Nicotine Tob Res. 2008 Sep;10(9):1441-8. doi: 10.1080/14622200802323258.

Reference Type BACKGROUND
PMID: 19023835 (View on PubMed)

Blank MD, Sams C, Weaver MF, Eissenberg T. Nicotine delivery, cardiovascular profile, and subjective effects of an oral tobacco product for smokers. Nicotine Tob Res. 2008 Mar;10(3):417-21. doi: 10.1080/14622200801901880.

Reference Type BACKGROUND
PMID: 18324559 (View on PubMed)

Breland AB, Kleykamp BA, Eissenberg T. Clinical laboratory evaluation of potential reduced exposure products for smokers. Nicotine Tob Res. 2006 Dec;8(6):727-38. doi: 10.1080/14622200600789585.

Reference Type BACKGROUND
PMID: 17132520 (View on PubMed)

Breland AB, Evans SE, Buchhalter AR, Eissenberg T. Acute effects of Advance: a potential reduced exposure product for smokers. Tob Control. 2002 Dec;11(4):376-8. doi: 10.1136/tc.11.4.376.

Reference Type BACKGROUND
PMID: 12432165 (View on PubMed)

Other Identifiers

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R01CA103827

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01CA120142

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM11820

Identifier Type: -

Identifier Source: org_study_id