Smoking Cessation Clinical Trial
Official title:
Modeling Tobacco Smoking by IV Pulsed Nicotine in Smokers
Verified date | July 2021 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | May 31, 2021 |
Est. primary completion date | April 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Veterans Affairs Hospital | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart rate will be used to see the dose effect | the dose-effect curves of nicotine dose and delivery rate in heart rate | During nicotine infusion max of ten minutes |
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