Impact of Switching to Non-Menthol Cigarettes Among Smokers

NCT03075839 | Completed Results DMC

• 2 other identifiers: 20000203341P50DA036151-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will investigate within-person changes in smoking behavior when current adult smokers are systematically switched from smoking menthol cigarettes to non-menthol cigarettes.

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (1)

• Total Number of Cigarettes Smoked

  Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes

  Menthol smoking (Week 2), Non-menthol smoking (Week 4)

Secondary Outcomes (2)

• Nicotine Dependence

  Week 4 (non-menthol)

• Quitting Interest

  Week 4 (non-menthol)

Study Arms (1)

Cigarette Brand Switching

EXPERIMENTAL

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

Other: Cigarette Brand Switching

Interventions

Cigarette Brand Switching OTHER

Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of two weeks

Cigarette Brand Switching

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

Related Publications (1)

• Bold KW, Jatlow P, Fucito LM, Eid T, Krishnan-Sarin S, O'Malley S. Evaluating the effect of switching to non-menthol cigarettes among current menthol smokers: an empirical study of a potential ban of characterising menthol flavour in cigarettes. Tob Control. 2020 Nov;29(6):624-630. doi: 10.1136/tobaccocontrol-2019-055154. Epub 2019 Nov 4.

  PMID: 31685586 DERIVED

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

* Analyses may be under-powered, a larger replication trial is needed * Some participants continued smoking menthol cigarettes during the study * Cigarettes were provided to encourage protocol adherence which may impact smoking behavior

Results Point of Contact

• Title: Krysten Bold
• Organization: Yale University

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: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 9, 2017
• Study Start: March 3, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: March 2, 2023
• Results First Posted: April 17, 2020

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)