NCT03164668

Brief Summary

The purpose of this formative study is to provide preliminary data regarding how the availability of menthol flavored e-cigarettes affects tobacco use behavior in the context of a ban on menthol flavored cigarettes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2019

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

July 10, 2024

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

2.5 years

First QC Date

May 22, 2017

Results QC Date

January 20, 2023

Last Update Submit

July 8, 2024

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Number of Cigarettes Smoked Per Day

    Number of cigarettes smoked per day as self-reported on tobacco diary

    1 month

  • Number of E-cigarette Puffs Used Per Day

    Self-reported number of puffs of e-cigarettes used per day

    1 month

Study Arms (4)

Usual cigs; menthol e-cig then tobacco e-cigs

OTHER

Participants can continue to smoke their usual cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes

Other: menthol flavored e-cigaretteOther: tobacco flavored e-cigarette

Usual cigs; tobacco e-cig then menthol e-cigs

OTHER

Participants can continue to smoke their usual cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes

Other: menthol flavored e-cigaretteOther: tobacco flavored e-cigarette

avoid menthol cigs; menthol e-cig then tobacco e-cigs

OTHER

Participants avoid smoking menthol cigarettes. For the first month of study they receive menthol flavored e-cigarettes and for the second month they receive tobacco flavored e-cigarettes

Other: menthol flavored e-cigaretteOther: tobacco flavored e-cigarette

avoid menthol cigs; tobacco e-cig then menthol e-cigs

OTHER

Participants avoid smoking menthol cigarettes. For the first month of study they receive tobacco flavored e-cigarettes and for the second month they receive menthol flavored e-cigarettes

Other: menthol flavored e-cigaretteOther: tobacco flavored e-cigarette

Interventions

menthol flavored e-cigaretteOTHER

menthol flavored e-cigarette

Usual cigs; menthol e-cig then tobacco e-cigsUsual cigs; tobacco e-cig then menthol e-cigsavoid menthol cigs; menthol e-cig then tobacco e-cigsavoid menthol cigs; tobacco e-cig then menthol e-cigs
tobacco flavored e-cigaretteOTHER

tobacco flavored e-cigarette

Usual cigs; menthol e-cig then tobacco e-cigsUsual cigs; tobacco e-cig then menthol e-cigsavoid menthol cigs; menthol e-cig then tobacco e-cigsavoid menthol cigs; tobacco e-cig then menthol e-cigs

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self identify as African American
  • smoke primarily menthol cigarettes
  • be between the ages of 18 and 64
  • smoke a minimum number of cigarettes per day
  • agree to abstain from menthol cigarettes for an 8 week period

You may not qualify if:

  • current unstable medical / psychiatric condition
  • regular use any form of nicotine or tobacco other than cigarettes
  • are pregnant or breast feeding
  • The investigators will evaluate if there are other reasons why someone may not be eligible to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Sciences Institute

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Michael Kotlyar
Organization
University of Minnesota
kotly001@umn.edu
612-625-1160

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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 23, 2017

Study Start

May 3, 2017

Primary Completion

November 1, 2019

Study Completion

November 26, 2019

Last Updated

July 10, 2024

Results First Posted

July 10, 2024

Record last verified: 2024-07

Locations

US(1)