NCT03612349

Brief Summary

In this study, participants will complete a behavioral economics laboratory task and validation field assessments to understand how menthol cigarette policy restrictions may affect tobacco product purchasing and use.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

July 9, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

July 26, 2018

Last Update Submit

September 27, 2018

Conditions

Keywords

cigarettessmoking

Outcome Measures

Primary Outcomes (1)

  • Total amount of combusted tobacco purchased in mg of nicotine.

    How much combusted tobacco is purchased by the participants.

    through study completion, an average of 2-weeks.

Secondary Outcomes (1)

  • Tobacco Product Demand Curves

    through study completion, an average of 2-weeks.

Study Arms (2)

Condition 1: All Products

OTHER

Experimental Tobacco Marketplace Task is a behavioral economics task. During the task, participants purchase products from an online tobacco marketplace. In this condition, all tobacco products are available in menthol and non-menthol flavors.

Behavioral: Experimental Tobacco Marketplace Task

Condition 2: No menthol LCCs

OTHER

Experimental Tobacco Marketplace Task is a behavioral economics task. During the task, participants purchase products from an online tobacco marketplace. In this condition, the online tobacco marketplace does not include menthol flavored little cigars and cigarillos.

Behavioral: Experimental Tobacco Marketplace Task

Interventions

Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.

Also known as: Condition 1: All Products, Condition 2: No menthol LCCs
Condition 1: All ProductsCondition 2: No menthol LCCs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 and older
  • Daily smokers who smoke on average at least 5 cigarettes per day for the past 12 months
  • Self-report smoking a menthol cigarette brand
  • Must report use of an alternative tobacco product(s) at least once in the past month
  • Breath CO levels \> 8 ppm (if \< 8 ppm, then NicAlert Strip = 6)
  • Speak, comprehend, and read English well enough to complete study procedures

You may not qualify if:

  • Breath alcohol level \> 0.01 ng/ml
  • Intention to quit smoking in the next 30 days
  • Self-reported serious medical or psychiatric conditions during the past 12 months including:
  • heart attack
  • stroke
  • angina
  • blood clots in the arms or legs for which the individual is undergoing active medical treatment
  • cancer requiring active chemotherapy or radiation therapy
  • chronic obstructive pulmonary disease
  • schizophrenia
  • Pregnant or breastfeeding
  • CO reading \> 80 ppm
  • Enrollment stratum (white or African-American/black) is full

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Tobacco UseCigarette SmokingSmoking

Condition Hierarchy (Ancestors)

BehaviorTobacco Smoking

Study Officials

  • Rachel Denlinger, MPH

    Brown University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Denlinger, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
There is no masking since participants experience both marketplace conditions.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Participants will complete the Experimental Tobacco Marketplace Task under two marketplace conditions. One condition has all tobacco products available in menthol and non-menthol flavors. The other condition does not include alternative flavored combusted products.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 2, 2018

Study Start

July 9, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2020

Last Updated

September 28, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations