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Effects of Flavors on Nicotine Reinforcement in Smokers

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ClinicalTrials.gov Identifier: NCT03243630
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: IV nicotine Drug: Menthol flavor Drug: green apple Drug: green apple and menthol Early Phase 1

Detailed Description:
This is a proposed double-blind, crossover study that enrolls young adult smokers who prefer menthol cigarettes. The study will consist of an adaptation session and three test sessions. In the adaptation session, participants will practice using the e-cigarette by sampling the flavors to be used in the test sessions. The test sessions will be performed following overnight abstinence from tobacco. Across the three test sessions, participants will be assigned to a random sequence of the three different e-cigarette conditions: menthol, green apple or menthol plus green apple, a different flavor condition for each test session. In each test session, just after the assigned flavor is delivered via the e-cigarette, participants will receive a random order of one intravenous delivery of saline, and two intravenous deliveries of nicotine (3.6 mcg/kg and 7 mcg/kg or 0.25 mg/70 kg and 0.5 mg/70kg), one hour apart. The test sessions will be performed at least 24 hours apart to minimize carryover nicotine effects. The main outcome measure will be subjective drug effects as measured with the Drug Effects Questionnaire (DEQ). Other outcomes include cardiovascular measures, cognitive performance, and self-report measures of nicotine withdrawal and craving. Cardiovascular measures include heart rate, systolic and diastolic blood pressure. Cognitive performance will be assessed with the Stroop test, mathematical processing test (MPT), and continuous performance test (CPT). Nicotine withdrawal measures will be measured with the Minnesota Nicotine Withdrawal Symptom Checklist (M-NWSC) and the Brief Questionnaire on Smoking Urges (BQSU).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Mixed-effects models will be used to test the study hypotheses. These models allow for different numbers of observations per subject, use all available data on each subject, and are unaffected by randomly missing data.
Masking: Double (Participant, Investigator)
Masking Description: The participant and medical professional will be blinded to the condition per day.
Primary Purpose: Health Services Research
Official Title: Effects of Flavors on Nicotine Reinforcement in Smokers
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Menthol e-liquid
Menthol Flavor + IV saline Menthol Flavor + IV nicotine (0.25mg/70kg) Menthol Flavor + IV nicotine (0.5mg/70kg)
Drug: IV nicotine
Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg
Other Name: nicotine, e-liquid

Drug: Menthol flavor
American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator
Other Name: menthol American e-liquids

Drug: green apple
green apple will be added to the menthol flavor
Other Name: green apple American e-liquids

Drug: green apple and menthol
menthol and green apple will be the active intervention
Other Name: green apple and menthol flavor American e-liquids

Active Comparator: green apple e-liquid
Green apple + IV saline Green apple + IV nicotine (0.25mg/70kg) Green apple + IV nicotine (0.5mg/70kg)
Drug: IV nicotine
Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg
Other Name: nicotine, e-liquid

Drug: Menthol flavor
American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator
Other Name: menthol American e-liquids

Drug: green apple
green apple will be added to the menthol flavor
Other Name: green apple American e-liquids

Drug: green apple and menthol
menthol and green apple will be the active intervention
Other Name: green apple and menthol flavor American e-liquids

Active Comparator: green apple and menthol e-liquid
Green apple and menthol + IV saline Green apple and menthol + IV nicotine (0.25mg/70kg) Green apple and menthol + IV nicotine (0.5mg/70kg)
Drug: IV nicotine
Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg
Other Name: nicotine, e-liquid

Drug: Menthol flavor
American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator
Other Name: menthol American e-liquids

Drug: green apple
green apple will be added to the menthol flavor
Other Name: green apple American e-liquids

Drug: green apple and menthol
menthol and green apple will be the active intervention
Other Name: green apple and menthol flavor American e-liquids




Primary Outcome Measures :
  1. The reinforcing drug effects will be measured with the drug effects questionnaire (DEQ). [ Time Frame: up to 3 hours ]
    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. Menthol and fruit flavor will be administered by inhalation via electronic cigarettes (e-cigarettes) and nicotine will be administered intravenously.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243630


Contacts
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Contact: Lance Barnes 203-937-4823 lance.barnes@yale.edu
Contact: Stacy Minnix, BSW 203-937-4805 stacy.minnix@yale.edu

Locations
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United States, Connecticut
Veterans Affairs Recruiting
West Haven, Connecticut, United States, 06516
Contact: Lance Barnes    203-937-4823      
Contact: Michael Stephens    203-932-5711      
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Mehmet Sofuoglu, M.D.Ph.D. Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03243630     History of Changes
Other Study ID Numbers: 2000021591
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Menthol
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents