Intravenous (IV) Nicotine Self Administration: Dose Ranging and Sex Differences in Smokers
What is the purpose of this trial?
The proposed study will examine the threshold for nicotine self-administration using four different nicotine doses in young adult male and female smokers without nicotine dependence (light and intermittent smokers or LITS). We propose a double-blind, placebo-controlled study that will enroll 195 individuals with 36 male and 36 female smokers and a total of 72 completers. Smokers will participate in five Lab sessions: one adaptation and four experimental sessions. In each of the four experimental sessions, smokers will be randomly assigned to one of the four doses of nicotine (1.5, 3.0, 4.5, and 6.0 mcg/kg, or about 0.1, 0.2, 0.3, and 0.4 mg/70 kg). At the beginning of each experimental session, smokers will sample the assigned nicotine dose for that experimental session, and placebo (saline), and then have the opportunity to choose between nicotine and placebo for a total of ten choices over a 180-minute period. The main outcomes will be threshold dose (the minimum dose of nicotine that is self-administered more than placebo) and the slope of dose-response for nicotine self-administration (changes in nicotine self-administration per unit change in nicotine dose). We will also collect measures of nicotine intake (cotinine), nicotine clearance (3-hydroxycotinine (3-HC) / cotinine), and self-report drug effects. Changes in smoking behavior and the use of other tobacco products will be assessed during follow-up visits at 3, 6 and 12 months. Urine cotinine and self-report measures of tobacco use will be collected.
- 18 Years - 25 Years
- Yale University
- October 2011
- Last Updated:
- March 17, 2014
- Study HIC#:
Clinicaltrials.gov ID: NCT01495819