Smoking by IV Pulsed Nicotine

• Status: Completed
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

Summary

To establish a dose-effect curve for nicotine's abuse potential as a function of nicotine dose and delivery rate. Pulsed IV nicotine administration will be used as it closely matches nicotine delivery by inhaled tobacco use.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• Female and male smokers, aged 18 to 35 years, who have been smoking tobacco cigarettes for at least a year

• smoke ≥ 5 and less than 20 cigarettes per day

• urine cotinine levels > 100 ng/mL consistent with nicotine intake of an active smoker

• not seeking treatment at the time of the study for nicotine dependence

• in good health as verified by medical history, screening examination, and screening laboratory tests; and 6) for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

• History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study

• regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)

• current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine

• use of e-cigarettes more than 10 days in the past 30 days

• urine drug screening indicating recent illicit drugs use (with the exception of marijuana)