Impact of Cigarette and E-cigarette Flavors on Adult Smoking Behavior

NCT04009850 | Terminated Results DMC

• 2 other identifiers: 20000255722U54DA036151-06
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate within-person changes in smoking behavior when current menthol smokers are switched to non-menthol cigarettes and either tobacco or menthol flavored e-cigarettes.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Total Number of Cigarettes Smoked

  Self-reported total number of cigarettes smoked per day (Timeline Follow Back)

  Week 6

Secondary Outcomes (4)

• E-cigarette Use

  Week 6

• Tobacco Product Satisfaction

  Week 6

• Motivation to Quit Smoking

  Week 6

• Nicotine Dependence

  Week 6

Study Arms (2)

Menthol e-cigarette

EXPERIMENTAL

Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a menthol flavored e-cigarette

Other: Cigarette Brand Switching

Tobacco e-cigarette

EXPERIMENTAL

Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes and a tobacco flavored e-cigarette

Other: E-cigarette Flavor

Interventions

Cigarette Brand Switching OTHER

Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes

Menthol e-cigarette

E-cigarette Flavor OTHER

Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes

Tobacco e-cigarette

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or older
• Able to read English
• Cigarette smoker

You may not qualify if:

• Seeking smoking cessation treatment
• Serious psychiatric or medical condition
• Use of other drugs
• Unable or unwilling to complete study protocol

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dr. Krysten Bold
• Organization: Yale School of Medicine

krysten.bold@yale.edu

203-974-7603

Study Officials

• Krysten Bold, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes with either menthol or tobacco flavored e-cigarettes

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 5, 2019
• Study Start: July 1, 2019
• Primary Completion: November 9, 2019
• Study Completion: January 31, 2022
• Last Updated: March 8, 2024
• Results First Posted: May 17, 2022

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)