Status:
COMPLETED
Smoking by IV Pulsed Nicotine
Lead Sponsor:
Yale University
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-35 years
Phase:
EARLY_PHASE1
Brief 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...
Detailed Description
Both sub-studies will enroll male and female tobacco cigarette smokers. This study will examine the feasibility of the proposed study parameters in a total of 10 completers. In a crossover design, par...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04488744
Start Date
November 15 2019
End Date
May 31 2021
Last Update
July 20 2021
Active Locations (1)
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1
Veterans Affairs Hospital
West Haven, Connecticut, United States, 06516