Nicotine Dependence | The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users
Nicotine Dependence research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:nicotineIn each of 3 test sessions, subjects in each arm will receive a randomized sequence of three intravenous infusions (30 sec each), one hour apart. The infusions will consist of saline, nicotine (.25 mg / 70kg) and nicotine (0.5 mg / 70 kg). The randomized sequence will remain the same between test sessions for a given subject.
Drug:mentholIn each of 3 test sessions, subjects will take 6 inhalations from the study e-cigarette, one inhalation every 15 seconds, of the randomized menthol condition for that test session ust prior to each intravenous infusion. The menthol conditions are: 3.2% menthol, 0.5% menthol and tobacco-flavor only (0.0% menthol)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Menthol-Preferring SmokersEach subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.
Non-Menthol Preferring SmokersEach subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.
Start Date: March 26, 2014
Completed Date: July 11, 2016
Primary Outcome: Drug Effects Questionnaire (DEQ)- 'Good Drug Effects'
Study sponsors, principal investigator, and references
Principal Investigator: Mehmet Sofuoglu, MD, PhD
Lead Sponsor: Yale University