Effects of E-Cigarette Flavors on Adults TCORS 2.0

Effects of E-Cigarette Flavors on Adults

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers.

Study Overview

• Status: Completed
• Conditions: Nicotine Use Disorder
• Intervention / Treatment: Drug: Nicotine; Drug: Flavor

Detailed Description

This study looks at the effects of flavors when administered with nicotine in e-cigarettes in younger and older adult cigarette smokers. Regular cigarette smokers who do not want to quit smoking will be asked to complete 3 lab sessions in which they will use an e-cigarette and complete questionnaires. This will be followed by a two-week period where participants are asked to stop using cigarettes and other tobacco products and to only use the e-cigarettes provided. Researchers will examine the influence of flavors (sweet, cool, tobacco) on reward (liking/wanting) from e-cigs containing one of two nicotine concentrations (6 mg/ml, 18 mg/ml) following acute tobacco abstinence.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Danielle Davis, PhD; Phone Number: 203-974-7607; Email: danielle.davis@yale.edu
• Study Contact Backup: Name: Thomas Liss; Email: thomas.liss@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • CMHC, Substance Abuse Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ages 18-24 years or 35 -50 years
• Able to read and write
• Smoking > 10 cigarettes or cigars/day
• Willing to abstain from regular smoking for 2 weeks and use only e-cigarettes
• Not seeking treatment to stop smoking
• No regular use of e-cigarettes

Exclusion Criteria:

• Daily use of other drugs including prescribed psychoactive drugs
• Any significant current medical or psychiatric condition
• Known hypersensitivity to propylene glycol
• Pregnant or lactating females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low nicotine, tobacco; 6 mg nicotine combined with tobacco flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, strawberry)
Experimental: Low nicotine, menthol; 6 mg nicotine combined with menthol flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, strawberry)
Experimental: Low nicotine, strawberry; 6 mg nicotine combined with strawberry flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, strawberry)
Experimental: High nicotine, tobacco; 18 mg nicotine combined with tobacco flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, strawberry)
Experimental: High nicotine, menthol; 18 mg nicotine combined with menthol flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, strawberry)
Experimental: Hign Nicotine, strawberry; 18 mg nicotine combined with strawberry flavored e-juice	Drug: Nicotine; Nicotine level (6 or 18 mg); Drug: Flavor; Flavor of e-juice (tobacco, menthol, strawberry)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change score in liking/wanting of e-cigarette	The Labeled Hedonic Scale (LHS; Lim et al., 2009) will be used to ask about liking and wanting of the e-cigarette (one item VAS scale with ratings from most disliked sensation imaginable to most liked sensation imaginable with higher values indicating greater liking)	Baseline (+10 minutes) to end of lab session (+40 minutes)

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2000023077-2; 2U54DA036151-06 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No