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Effects of Flavors on Nicotine Reinforcement in Smokers

NCT ID: NCT03243630

Last Updated: 2020-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-23

Study Completion Date

2019-01-31

Brief Summary

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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).

Detailed Description

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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).

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators
The participant and medical professional will be blinded to the condition per day.

Study Groups

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Menthol e-liquid

Menthol Flavor + IV saline Menthol Flavor + IV nicotine (0.25mg/70kg) Menthol Flavor + IV nicotine (0.5mg/70kg)

Group Type PLACEBO_COMPARATOR

IV nicotine

Intervention Type DRUG

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

Menthol flavor

Intervention Type DRUG

American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator

green apple

Intervention Type DRUG

green apple will be added to the menthol flavor

green apple and menthol

Intervention Type DRUG

menthol and green apple will be the active intervention

green apple e-liquid

Green apple + IV saline Green apple + IV nicotine (0.25mg/70kg) Green apple + IV nicotine (0.5mg/70kg)

Group Type ACTIVE_COMPARATOR

IV nicotine

Intervention Type DRUG

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

Menthol flavor

Intervention Type DRUG

American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator

green apple

Intervention Type DRUG

green apple will be added to the menthol flavor

green apple and menthol

Intervention Type DRUG

menthol and green apple will be the active intervention

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)

Group Type ACTIVE_COMPARATOR

IV nicotine

Intervention Type DRUG

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

Menthol flavor

Intervention Type DRUG

American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator

green apple

Intervention Type DRUG

green apple will be added to the menthol flavor

green apple and menthol

Intervention Type DRUG

menthol and green apple will be the active intervention

Interventions

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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

Intervention Type DRUG

Menthol flavor

American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator

Intervention Type DRUG

green apple

green apple will be added to the menthol flavor

Intervention Type DRUG

green apple and menthol

menthol and green apple will be the active intervention

Intervention Type DRUG

Other Intervention Names

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nicotine, e-liquid menthol American e-liquids green apple American e-liquids green apple and menthol flavor American e-liquids

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Sofuoglu

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Sofuoglu, M.D.Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Veterans Affairs

West Haven, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1P50DA036151-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000021591

Identifier Type: -

Identifier Source: org_study_id