Tobacco Use DisorderNCT03164668

Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes

A study testing menthol flavored e-cigarette and tobacco flavored e-cigarette in people with Tobacco Use Disorder, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Tobacco Use Disorder
What is being tested?: menthol flavored e-cigarette and tobacco flavored e-cigarette
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteUnited States
Study dates: 3 May 2017to 26 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical and Translational Sciences Institute
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Conditions: Tobacco Use Disorder
Being tested: menthol flavored e-cigarette, tobacco flavored e-cigarette
Medical subject headings: Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

menthol flavored e-cigaretteOther
menthol flavored e-cigarette
tobacco flavored e-cigaretteOther
tobacco flavored e-cigarette

Study groups in NCT03164668
Study group	Role	What they receive
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 Receives: Other: menthol flavored e-cigarette; Other: 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 Receives: Other: menthol flavored e-cigarette; Other: 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 Receives: Other: menthol flavored e-cigarette; Other: 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 Receives: Other: menthol flavored e-cigarette; Other: tobacco flavored e-cigarette

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Cigarettes Smoked Per Day
Number of cigarettes smoked per day as self-reported on tobacco diary
Measured: 1 month
Number of E-cigarette Puffs Used Per Day
Self-reported number of puffs of e-cigarettes used per day
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 201726 Nov 2019

First posted23 May 2017
Study start3 May 2017
Primary completion1 Nov 2019
Study completion26 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03164668
Sponsor's protocol ID: 1609M94682
Status last verified: Jul 2024
First submitted: 22 May 2017
Last updated: 10 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
Recruiting
Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily
Tobacco Use Disorder
Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
Cardiovascular Impacts of E-cigarettes Among Older Adults
Hypertension, Tobacco Cigarette Smoking

All Tobacco Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Menthol Flavored E-cigarette Use During a Simulated Ban of Menthol Cigarettes
ClinicalTrials.gov ID: NCT03164668
Acronym / sponsor ID: 1609M94682
Conditions: Tobacco Use Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 3 May 2017 (actual)
Primary completion: 1 Nov 2019 (actual)
Study completion: 26 Nov 2019 (actual)
First posted: 23 May 2017 (actual)
Results: Posted 10 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Usual cigs; menthol e-cig then tobacco e-cigs	Other	Other: menthol flavored e-cigarette, Other: tobacco flavored e-cigaretteParticipants 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
Usual cigs; tobacco e-cig then menthol e-cigs	Other	Other: menthol flavored e-cigarette, Other: tobacco flavored e-cigaretteParticipants 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
avoid menthol cigs; menthol e-cig then tobacco e-cigs	Other	Other: menthol flavored e-cigarette, Other: tobacco flavored e-cigaretteParticipants 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
avoid menthol cigs; tobacco e-cig then menthol e-cigs	Other	Other: menthol flavored e-cigarette, Other: tobacco flavored e-cigaretteParticipants 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

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
menthol flavored e-cigarettementhol flavored e-cigarette	Other	Usual cigs; menthol e-cig then tobacco e-cigs, Usual cigs; tobacco e-cig then menthol e-cigs, avoid menthol cigs; menthol e-cig then tobacco e-cigs, avoid menthol cigs; tobacco e-cig then menthol e-cigs
tobacco flavored e-cigarettetobacco flavored e-cigarette	Other	Usual cigs; menthol e-cig then tobacco e-cigs, Usual cigs; tobacco e-cig then menthol e-cigs, avoid menthol cigs; menthol e-cig then tobacco e-cigs, avoid menthol cigs; tobacco e-cig then menthol e-cigs

Primary outcome

Number of Cigarettes Smoked Per Day
Time frame: 1 month
Number of cigarettes smoked per day as self-reported on tobacco diary
Number of E-cigarette Puffs Used Per Day
Time frame: 1 month
Self-reported number of puffs of e-cigarettes used per day

Results and safety

Results posted to the registry on 10 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Avoid Menthol Cigs; Menthol E-cig Then Tobacco E-cigs	11	10
Avoid Menthol Cigs; Tobacco E-cig Then Menthol E-cigs	7	5
Usual Cigs; Menthol E-cig Then Tobacco E-cigs	10	6
Usual Cigs; Tobacco E-cig Then Menthol E-cigs	9	6

Primary outcome: Number of Cigarettes Smoked Per Day

Time frame: 1 month. Number. Unit: model estimated cigarettes per day

Measure	Avoid Menthol Cigarettes; Menthol E-cigarettes n = 16	Avoid Menthol Cigarettes; Tobacco E-cigarettes n = 17	Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes n = 13	Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes n = 13
Value	2.2	1.8	6.0	7.1

Avoid Menthol Cigarettes; Menthol E-cigarettes vs Avoid Menthol Cigarettes; Tobacco E-cigarettes vs Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes vs Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes: Estimated mean ratio: 0.31 (95% CI 0.13 to 0.72)
Avoid Menthol Cigarettes; Menthol E-cigarettes vs Avoid Menthol Cigarettes; Tobacco E-cigarettes vs Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes vs Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes: Estimated mean ratio: 0.98 (95% CI 0.78 to 1.22)

Population analysed: Participants were randomized to either continue to smoke their usual cigarettes or to avoid menthol cigarettes. Within each group, participants received, in random order, one month of menthol flavored e-cigarettes and one month of tobacco flavored e-cigarettes. The overall number of participants entered for each outcome therefore represents the total number from both relevant randomization conditions (see Participant flow for details) in whom at least 1 week of data was provided.

Primary outcome: Number of E-cigarette Puffs Used Per Day

Time frame: 1 month. Number. Unit: model estimated e-cig puffs per day

Measure	Avoid Menthol Cigarettes; Menthol E-cigarettes n = 16	Avoid Menthol Cigarettes; Tobacco E-cigarettes n = 18	Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes n = 16	Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes n = 15
Value	61.4	57	25.5	14.9

Avoid Menthol Cigarettes; Menthol E-cigarettes vs Avoid Menthol Cigarettes; Tobacco E-cigarettes vs Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes vs Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes: Estimated mean ratio: 3.03 (95% CI 1.39 to 6.61)
Avoid Menthol Cigarettes; Menthol E-cigarettes vs Avoid Menthol Cigarettes; Tobacco E-cigarettes vs Can Continue Smoking Usual Cigarettes; Menthol E-cigarettes vs Can Continue Smoking Usual Cigarettes; Tobacco E-cigarettes: Estimated mean ratio: 0.74 (95% CI 0.59 to 0.92)

Adverse events

Time frame: For the duration of each participant's participation in the specified condition (up to approximately 4 weeks for each participant). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Avoid Menthol Cigarettes; Receive Menthol E-cigarettes	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Avoid Menthol Cigarettes; Receive Tobacco E-cigarettes	0 of 18 (0%)	1 of 18 (5.6%)	0 of 18
Usual Cigarettes; Receive Menthol E-cigarettes	0 of 16 (0%)	1 of 16 (6.3%)	0 of 16
Usual Cigarettes; Receive Tobacco E-cigarettes	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tobacco Use Disorder

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Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing menthol flavored e-cigarette and tobacco flavored e-cigarette in people with Tobacco Use Disorder, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Cigarettes Smoked Per Day (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03164668.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.