NCT04740008

Brief Summary

The purpose of this research is to evaluate the effects of low nicotine content cigarette (LNC) educational messaging on perceptions of low nicotine cigarettes, tobacco/nicotine product choice preferences (hypothetical), LNC cigarette subjective ratings, and LNC cigarette abuse liability among adult smokers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Apr 2021

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

First Submitted

Initial submission to the registry

February 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2022

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

February 1, 2021

Last Update Submit

February 23, 2024

Conditions

SmokingCigarette

Keywords

Low Nicotine ContentEducational MessagingCigaretteSmoking

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants that choose ANDS or no tobacco

    Proportion of participants who select to use ANDS or no tobacco if LNC cigarettes were the only cigarettes available will be compared in arm 1 versus arm 2

    Within 17 days of virtual screening

Study Arms (2)

Control message on low nicotine cigarettes

EXPERIMENTAL
Drug: Low Nicotine Content CigarettesOther: Control message

Test message on low nicotine cigarettes

EXPERIMENTAL
Drug: Low Nicotine Content CigarettesOther: Test message

Interventions

Low Nicotine Content CigarettesDRUG

Low Nicotine Content Cigarettes 0.4 mg/g nicotine; 9 mg tar Other Name: Reduced Nicotine Content Cigarettes

Control message on low nicotine cigarettesTest message on low nicotine cigarettes
Control messageOTHER

Participants will read control message

Control message on low nicotine cigarettes
Test messageOTHER

Participants will read test message

Test message on low nicotine cigarettes

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • At least 21 years of age
  • Biochemically confirmed smoker

You may not qualify if:

  • Unstable health condition
  • Unstable medications
  • Pregnant or nursing
  • Unreliable access to a computer, smart phone or tablet without working camera and internet access for telehealth visits and online questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota, Tobacco Research Program, 717 Delaware St., SE

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dana Mowls Carroll, Ph.D., M.P.H

    Masonic Cancer Center, University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 5, 2021

Study Start

April 20, 2021

Primary Completion

August 24, 2022

Study Completion

August 24, 2022

Last Updated

February 26, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Carroll). Data will be available in two formats. One will be a summary of the data, with graphs and tables, posted as pdf files and as raw individual-level data for analysis. Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota

Time Frame
Data will not be available until primary and secondary papers are accepted for publication.
Access Criteria
Persons requesting data must do so in writing, identifying their affiliation and how the data will be used. Upon review, access will be determined.

Locations

US(1)