Effects of Flavors on Nicotine Reinforcement in Smokers
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT03243630 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- IV nicotine (Drug); Menthol flavor (Drug); green apple (Drug); green apple and menthol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ). |
43.18; 26.22; 25.20; 56.00; 53.44; 50.80 | — |
Summary
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03243630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.