Effects of Flavors on Nicotine Reinforcement in Smokers
2 other identifiers
interventional
26
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Apr 2018
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2017
CompletedFirst Posted
Study publicly available on registry
August 9, 2017
CompletedStudy Start
First participant enrolled
April 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedResults Posted
Study results publicly available
November 13, 2020
CompletedDecember 3, 2020
November 1, 2020
8 months
August 4, 2017
July 31, 2020
November 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The Reinforcing Drug Effects Will be Measured With the Drug Effects Questionnaire (DEQ).
The (DEQ) Drug Effects Questionnaire has eleven questions with a minimum score of 0 to a maximum score of 100. Peak values from each time points were calculated for the change in the intensity of positive subjective effects as measured with these peak values for like and want more were averaged to obtain a summary score to represent the feel "good drug effects" composite factor. Higher scores for each DEQ represent greater endorsement of that subjective effect (e.g., on the "like drug" scale a response of 90 represents greater liking than a response of 50).
up to 3 hours per test session.
Study Arms (3)
Menthol e-liquid
PLACEBO COMPARATORMenthol Flavor + IV saline Menthol Flavor + IV nicotine (0.25mg/70kg) Menthol Flavor + IV nicotine (0.5mg/70kg)
green apple e-liquid
ACTIVE COMPARATORGreen apple + IV saline Green apple + IV nicotine (0.25mg/70kg) Green apple + IV nicotine (0.5mg/70kg)
green apple and menthol e-liquid
ACTIVE COMPARATORGreen apple and menthol + IV saline Green apple and menthol + IV nicotine (0.25mg/70kg) Green apple and menthol + IV nicotine (0.5mg/70kg)
Interventions
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
American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator
green apple will be added to the menthol flavor
menthol and green apple will be the active intervention
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Veterans Affairs
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mehmet Sofuoglu
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Mehmet Sofuoglu, M.D.Ph.D.
Yale University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The participant and medical professional will be blinded to the condition per day.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
August 4, 2017
First Posted
August 9, 2017
Study Start
April 23, 2018
Primary Completion
December 19, 2018
Study Completion
January 31, 2019
Last Updated
December 3, 2020
Results First Posted
November 13, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share