Clinical trial

The Interaction of Flavor With Nicotine Form in Adult Smokers

Name

2000025687

Description

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.

Trial arms

Trial start

2020-11-01

Estimated PCD

2022-01-10

Trial end

2022-02-02

Status

Completed

Phase

Early phase I

Treatment

Nicotine form

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

Arms:

E-cigarette flavor, E-cigarette nicotine form

E-cigarette experimental flavor

Participants will receive menthol and tobacco flavored e-cigarettes

Arms:

E-cigarette flavor, E-cigarette nicotine form

Size

Primary endpoint

Changes in Liking of E-cigarette Overall

up to 3 weeks

Changes in Liking of E-cigarette Flavor

up to 3 weeks

Eligibility criteria

Inclusion Criteria: * At least 21 years old, able to read and write, use of combustible Exclusion Criteria: -

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}

Updated at

2023-05-26

1 organization

1 product

1 indication

Organization

Yale University

Product

Nicotine

Indication

Nicotine Dependence