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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00932295 |
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Date of registration:
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02/07/2009 |
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Primary sponsor: |
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Public title:
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Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.
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Scientific title:
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Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers. |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00932295 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Thomas Eissenberg, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Virginia Commonwealth University |
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Key inclusion & exclusion 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).
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Focus is on Cigarette Smokers.
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No Conditions: This is Not a Treatment Study.
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Intervention(s)
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Other: CROWN SEVEN
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Other: NJOY
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Other: OB
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Other: Sham smoking
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Primary Outcome(s)
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Plasma nicotine concentration (ng/ml)
[Time Frame: baseline, 5, 15, 30, and 45 minutes post-use]
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Secondary Outcome(s)
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Heart rate
[Time Frame: continuous]
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Withdrawal suppression (subjective measure)
[Time Frame: baseline and 5, 15, 30, and 45 minutes post-use]
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Secondary ID(s)
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HM11820
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R01CA103827
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R01CA120142
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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