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Summary

for people ages 21 years and up (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to learn more about nicotine exposure and the safety of electronic cigarettes (EC). It will focus on the areas that are thought to most closely relate to the addictive potential of EC, namely: (1) EC as nicotine delivery devices, covering issues of nicotine intake and pharmacokinetics, temporal patterns of use and titration of nicotine; and (2) subjective effects of EC use, including relationship of use to reward, withdrawal and craving.

Official Title

Clinical Pharmacology of Electronic Cigarettes R01DA039264

Details

Electronic cigarettes (EC) are nicotine delivery devices that generate a nicotine-containing aerosol which is inhaled by the user. EC are perceived by users to be useful in helping quitting smoking of conventional tobacco cigarettes (TC) as well as having a presumed lower risk of adverse health effects compared to TC, the potential for use in public places, reduced cost, and lack of the noxious clinging odors associated with TC use. Many believe that electronic cigarette (EC) function as nicotine delivery devices in the same way as tobacco cigarettes (TC), and that EC will prove to be just as addictive as TC, but this may not be the case because of fundamental differences in the design and method of use of these products. Investigators hypothesize that systemic nicotine exposure will be lower with EC compared to TC; that despite lower nicotine intake EC users will experience similar reward and no greater withdrawal symptoms or craving compared to TC; and that dual EC/ TC users will not titrate their daily intake of nicotine in the same way that TC smokers of high- vs low-yield nicotine TC do.

Investigators specifically focus on the areas that are thought to most closely relate to the addictive potential of EC, namely: (1) EC as nicotine delivery devices, covering issues of nicotine intake and pharmacokinetics, temporal patterns of use and titration of nicotine; and (2) subjective effects of EC use, including relationship of use to reward, withdrawal and craving. The investigators will also examine aspects of safety of EC use (by assessment of cardiovascular and hormonal effects of use and of biomarkers of exposure to potentially toxic constituents) and explore the identification and validation of biomarkers that may be useful in distinguishing EC from TC use. Study subjects will be dual users of TC and EC so that the investigators may compare both modalities of use in experienced users in a within-subject design.

The study will consist of two 1-week blocks (EC-only or TC-only conditions) with 4 days of outpatient ad libitum product use followed by 3 days in a clinical research ward to include a single-use pharmacokinetic study, monitoring of product use, subjective assessments, blood and urine collections to assess biomarkers, and a 24-hour period of cardiovascular monitoring. Two additional days at the end of the 2nd block will assess similar measurements during a period of nicotine-product abstention.

Keywords

Nicotine Dependence Tobacco Use Disorder

Eligibility

You can join if…

Open to people ages 21 years and up

  • Healthy on the basis of medical history and limited physical examination
  • Current regular "dual" user of both EC and conventional TC
  • EC device is one of the most popular 1st or 2nd generation brands as determined at time of study commencement
  • Age: ≥ 21 years

You CAN'T join if...

  • Unstable medical conditions
  • Unstable psychiatric conditions
  • Current regular use of selected psychiatric medications
  • Current regular use of cardiovascular medication
  • Current regular use of medications inducers of nicotine metabolizing enzymes
  • Pregnancy or breastfeeding (by history and pregnancy test)
  • Concurrent regular use of marijuana, smokeless tobacco, pipes or cigars
  • Concurrent use of nicotine-containing medications
  • Alcohol or illicit drug dependence within the past 12 months
  • Current illicit drug use (by history or urine test)
  • Concurrent participation in another clinical trial
  • Inability to communicate in English

Locations

  • San Francisco General Hospital (SFGH) accepting new patients
    San Francisco, California, 94110, United States
  • University of California, San Francisco (UCSF) accepting new patients
    San Francisco, California, 94110, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02470754
Lead Scientist
Neal L Benowitz
Study Type
Interventional
Last Updated
August 30, 2017
I’m interested in this study!