Smoking by IV Pulsed Nicotine

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

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.

Key facts

Study ID

NCT04488744

Run by

Yale University

People needed

13

Starts

2019-11-15

Expected to finish

2021-05-31

Last updated by the study team

2021-07-20

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Veterans Affairs Hospital — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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