IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate
Yale University
Summary
This project will examine the impact of the nicotine dose and delivery rate on nicotine's abuse potential, versus its potentially beneficial effects on smoking urges and withdrawal. Will use pulsed IV nicotine administration which closely matches nicotine delivery by inhaled tobacco use.
Description
Seventy smokers will be randomized to nicotine doses of either 0.2 or 1 mg per 70 kg body weight. Across 5 test sessions, within each dose group, participants will be randomly assigned to a sequence of 5 treatment conditions: placebo (saline) and 4 different delivery rates of nicotine. In each session, participants will receive either nicotine- or saline-pulsed infusions that will be delivered every 30 seconds for a total of 10 pulsed infusions. While receiving the pulsed infusions, participants will inhale a tobacco-flavored EC without nicotine, which will allow for a closer matching of the s…
Eligibility
- Age range
- 21–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Female and male, aged 21 to 55 years; * past year daily cigarette use, verified by urine cotinine levels above 100 ng/ml -lifetime history of e-cigarette use; in good health as verified by medical history -screening examination, and screening laboratory tests * women, -using acceptable birth control methods. Exclusion Criteria: * History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study * risk factors for EVALI (E-cigarette or Vaping Product Use-Associated Lung Injury) including his…
Interventions
- Druglow dose Nicotine
IV nicotine infused over different delivery rates
- Drughigh dose Nicotine
IV Nicotine infused over different delivery rates
Location
- VA Healthcare SystemWest Haven, Connecticut