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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?

Nicotine Dependence

Study Interventions

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:IV nicotineSubjects in each arm will receive three infusions in a fixed order one hour apart. The first infusion will be saline, the second infusion will be nicotine (.25 mg / 70kg) and the third infusion will be nicotine (0.5 mg / 70 kg).

Drug:Tobacco FlavorA popular 'Burly' tobacco flavor used in e-cigarettes will be used as the placebo comparator.

Drug:Low dose MentholA low dose of menthol will be added to the tobacco flavor.

Drug:High Dose MentholA higher dose of menthol added to tobacco flavor will be an active intervention.

Study Arms

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.

Tobacco flavorTobacco Flavor + IV saline, Tobacco Flavor + IV nicotine (0.25 mg/70kg), Tobacco Flavor + IV nicotine (0.5 mg/70kg)

Low dose mentholLow dose menthol + IV saline, Low dose menthol + IV nicotine (0.25 mg/70kg), Low dose menthol + IV nicotine (0.5 mg/70kg)

High dose mentholHigh dose menthol + IV saline, High dose menthol + IV nicotine (0.25 mg/70kg), High dose menthol + IV nicotine (0.5 mg/70kg)

Study Status

Completed

Start Date: March 26, 2014

Completed Date: July 11, 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Peak Change on Items of the Drug Effects Questionnaire (DEQ)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Mehmet Sofuoglu, MD, PhD

Lead Sponsor: Yale University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02102100

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