The Interaction of Flavor With Nicotine Form in Adult Smokers

NCT04262817 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 20000256872U54DA036151-061K01DA051882-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and nicotine exposure from e-cigarettes containing different forms of nicotine.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (2)

• Changes in Liking of E-cigarette Overall

  Following each puff, each participant was assessed to determine if they liked/disliked the overall e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.

  up to 3 weeks

• Changes in Liking of E-cigarette Flavor

  Following each puff, each participant was assessed to determine if they liked/disliked the flavors in the e-cigarette experience using the Labeled Hedonic Scale (LHS), a bipolar category-ratio scale with 5 symmetrical semantic labels positioned on the scale per their semantic magnitude that ranges from -100 (Most Disliked) to 100 (Most Liked) with "Neither Liked nor Disliked" at the midpoint.

  up to 3 weeks

Secondary Outcomes (4)

• gLMS: Sweetness

  up to 3 weeks

• gLMS: Coolness

  up to 3 weeks

• gLMS: Irritation

  up to 3 weeks

• Number of Puffs

  up to 3 weeks

Study Arms (2)

E-cigarette flavor

EXPERIMENTAL

In this arm, participants will receive two experimental e-cigarette flavors

Drug: Nicotine form; Other: E-cigarette experimental flavor

E-cigarette nicotine form

EXPERIMENTAL

In this arm, participants will receive two forms of nicotine in an e-cigarette

Drug: Nicotine form; Other: E-cigarette experimental flavor

Interventions

Nicotine form DRUG

participants will receive 36mg/ml nicotine salt and freebase nicotine

E-cigarette flavor; E-cigarette nicotine form

E-cigarette experimental flavor OTHER

Participants will receive menthol and tobacco flavored e-cigarettes

E-cigarette flavor; E-cigarette nicotine form

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 21 years old, able to read and write, use of combustible

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Pierce Laboratory

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Asti Jackson, Ph.D.
• Organization: Yale School of Medicine

asti.jackson@yale.edu

475-241-4904

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 10, 2020
• Study Start: November 1, 2020
• Primary Completion: January 10, 2022
• Study Completion: February 2, 2022
• Last Updated: May 26, 2023
• Results First Posted: May 26, 2023

Record last verified: 2023-05

Locations

US (1)