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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932295
• Other study ID #: HM11820
• Secondary ID: R01CA103827R01CA
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 2, 2009
• Last updated: December 12, 2016
• Start date: February 2009
• Est. completion date: October 2009

Study information

• Verified date: December 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Smoking

Intervention

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

Locations

Country	Name	City	State
United States	Clinical Behavioral Pharmacology Laboratory	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma nicotine concentration (ng/ml)		baseline, 5, 15, 30, and 45 minutes post-use	No
Secondary	Heart rate		continuous	Yes
Secondary	Withdrawal suppression (subjective measure)		baseline and 5, 15, 30, and 45 minutes post-use	No