N/A
N=57
The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02102100 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Drug Effects Questionnaire (DEQ)- 'Good Drug Effects' — 5.1979; 6.8384; 5.6235; 7.6285 scores on a scale — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nicotine (Drug); menthol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drug Effects Questionnaire (DEQ)- 'Good Drug Effects' |
5.1979; 6.8384; 5.6235; 7.6285; 5.226; 7.4351 | <.0001 sig |
Summary
This study will help determine if menthol administered by inhalation via electronic cigarettes (e-cigarette) changes the reinforcing effects of pure nicotine administered intravenously in cigarette smokers who smoke mentholated or non-mentholated cigarettes.
Eligibility Criteria
Inclusion Criteria
- Female and male 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);
- A 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.
Data sourced from ClinicalTrials.gov (NCT02102100). 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.