Effects of Flavors on Nicotine Reinforcement in Smokers
Completed · Early Phase 1 · Has a placebo group
Conditions studied: Nicotine Dependence
In brief
To examine the acute reinforcing effects of menthol, a fruit flavor (green apple) or a fruit flavor plus menthol, alone or in combination with nicotine in smokers. Flavors will be administered by inhalation via electronic cigarettes (e-cigarettes) and nicotine will be administered intravenously. The reinforcing drug effects will be measured with the drug effects questionnaire (DEQ).
Key facts
- Study ID
- NCT03243630
- Run by
- Yale University
- People needed
- 26
- Starts
- 2018-04-23
- Expected to finish
- 2019-01-31
- Last updated by the study team
- 2020-12-03
Who can join
Age: 18 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Female and male mentholated cigarette smokers, aged 18 to 30 years; history of smoking for the past 12 months, at least one cigarette per day; smoking status is verified with urinary cotinine levels above 10 ng/ml; not seeking treatment for nicotine dependence at the time of study entry in good health as verified by medical history, screening examination, and screening laboratory tests; 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 illnesses that the physician investigator deems as contraindicated for the patient to be in the study; regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics); psychiatric diagnosis and / or treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia or panic disorder in the past month; abuse of alcohol or any other recreational or prescription drugs in the past 30 days; any allergy to propylene glycol or menthol; and 6) aversion to green apple flavor.
Where it is running
- Veterans Affairs — West Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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