Cigarette SmokingENHANCENCT04340947

Cigarette Smoking Among Young Adults

A study testing Very low nicotine cigarette: menthol and Very low nicotine cigarette: non-mentol in people with Cigarette Smoking and Smoking Behaviors, run by University of Oklahoma 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

This study will examine perceptions and smoking behavior of menthol and non-menthol very low nicotine cigarettes in young adult smokers. The aims are to examine perceptions and smoking behavior in the laboratory and in the natural environment. Read more about this study

Who is it for?: Ages 18 to 34 yearsHealthy volunteers can take part
Conditions the study is for: Cigarette Smoking, Smoking Behaviors
What is being tested?: Very low nicotine cigarette: menthol and Very low nicotine cigarette: non-mentol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 171 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2021to 30 Apr 2024
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 34 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Ages18 to 34;
Smoke cigarettes "somedays" or "everyday" for at least the past 3-months;
A strong preference for menthol cigarettes (i.e., smoke menthol >80% of the time); and
Ability to read English at an 8th grade level or higher;
No immediate plans to quit smoking.

Who cannot join

Current use of nicotine replacement therapy (NRT);
Pregnant or planning to become pregnant, or currently breastfeeding;
Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion;
Serious psychiatric disorder;
Inability to abstain from nicotine/tobacco products;
Strong preference for non-menthol cigarettes (smoke non-menthol > 80% of the time)

Trial locations and contacts

1 site in 1 country.

United States1 site

Health Promotion Research Center
Oklahoma City, Oklahoma, 73104

Other trials in United States

About this study

Official title: Impact of a Reduced Nicotine Standard on Young Adult Appeal for Menthol and Non-menthol Cigarettes

Read the detailed description

This proposal includes three different aspects of assessment for menthol smoking young adults. The laboratory phase includes three separate sessions of laboratory smoking through a machine designed to measure puff behavior; the EMA phase includes 21 days of monitoring smoking behavior and attitudes related to smoking when smoking one's usual brand cigarette, the assigned menthol low nicotine cigarette, and the assigned non-menthol low nicotine cigarette in the participant's natural environment. The order of administration of smoking menthol and non-menthol VLNC will be counterbalanced. There will be a 7-day wash-out period between each 7-day period of using low nicotine cigarettes. The final phase includes a virtual marketplace where participants can purchase and use the research cigarettes in the context of other available tobacco products on the market, or purchase no tobacco products at all. There will be a final assessment, over the phone or in-person, 30-days after the final study visit (at week 8), to assess tobacco use behavior and attitudes about tobacco use. Participants will be enrolled for approximately 9 weeks. Week 1 will consist of smoking one's usual brand of cigarette in the laboratory and then in their home environment for 7-days. Week 2 will consist of smoking the first very low nicotine cigarette in the home environment for 7 days and then in the laboratory. Week three will consist of a 7-day wash-out period where participants can smoke their usual brand again, as they normally would. Week 4 will consist of smoking the second very low nicotine cigarette at home for 7 days and then in the laboratory. Week 5 will consist of returning to the laboratory for a final study visit and complete a hypothetical experimental tobacco marketplace. One month (4 weeks) after the final study visit (week 9), participants will complete a 30-day follow-up of cigarette smoking and other tobacco use behavior.

Conditions: Cigarette Smoking, Smoking Behaviors
Being tested: Very low nicotine cigarette: menthol, Very low nicotine cigarette: non-mentol
Medical subject headings: Cigarette Smoking, Smoking

What participants receive

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

Very low nicotine cigarette: mentholOther
Participants will be randomized to smoke either menthol non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory first and then crossed over to receive the opposite intervention. The study consists of two treatment periods of 7 days separated by a 1 week wash-out period
Very low nicotine cigarette: non-mentolOther
Participants will be randomized to smoke either menthol non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory first and then crossed over to receive the opposite intervention. The study consists of two treatment periods of 7 days separated by a 1 week wash-out period

Study groups in NCT04340947
Study group	Role	What they receive
Menthol very low nicotine cigarette (VLNC), then non-menthol VLNC	Experimental	Participants will smoke menthol flavored very low nicotine cigarettes in their home environment for 7 days. At the end of 7-days, they will also smoke one menthol flavored very low nicotine cigarette in the laboratory. Receives: Other: Very low nicotine cigarette: menthol; Other: Very low nicotine cigarette: non-mentol
Non-menthol very low nicotine cigarette (VLNC), then menthol VLNC	Experimental	Participants will smoke non-menthol flavored very low nicotine cigarettes in their home environment for 7 days. At the end of 7-days, they will also smoke one non-menthol flavored very low nicotine cigarette in the laboratory. Receives: Other: Very low nicotine cigarette: menthol; Other: Very low nicotine cigarette: non-mentol

What is being measured

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

Puff Topography
total inhalation volume from smoking behavior in the laboratory
Measured: Baseline to week 4
Ratings of Psychological Reward
Subjective response to smoking, as measured by self-reported psychological reward (scale) of the modified Cigarette Evaluation Scale, administered after smoking. The minimum value is 1 and the maximum value is 7; with 7 indicating greater psychological reward.
Measured: Baseline to week 9
Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs)
Purchasing of non-menthol very low nicotine cigarettes in the Experimental Tobacco Marketplace (ETM) task 1 and 2. Product units purchased per cigarette price displayed in the ETM, displayed as milligrams of nicotine. Prices are $0.12, $0.25, $0.5, $1, $2, $4, $8, and $16 per cigarette. Data are presented as units purchased on a log scale, per recommended best practices.
Measured: Assessed during tobacco purchase tasks completed at week 5

Secondary outcomes (1)

Exhaled CO Boost
measures expired alveolar carbon monoxide (CO) level before smoking and after smoking; measured in parts per million (ppm)
Measured: Baseline to week 4

Timeline

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

1 Aug 202130 Apr 2024

First posted10 Apr 2020
Study start1 Aug 2021
Primary completion30 Mar 2024
Study completion30 Apr 2024

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cigarette SmokingStudies of the same condition, open and under way.
More trials run by University of OklahomaThe sponsor's other registered studies.
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: 171 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04340947
Sponsor's protocol ID: ENHANCE
Other IDs: R01DA050990
Acronym: ENHANCE
Status last verified: Aug 2025
First submitted: 25 Mar 2020
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Cohn AM, Cassidy R, Denlinger-Apte R, Donny E, Villanti AC, Hatsukami D, Dunn D, Wyatt R, Niznik T, Cohen-Davidyan T, Smith M, Ehlke SJ. Impact of a reduced nicotine standard on young adult appeal for menthol and non-menthol cigarettes. BMJ Open. 2022 Nov 21;12(11):e067694. doi: 10.1136/bmjopen-2022-067694.
PubMed 36410805

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

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of a Reduced Nicotine Standard on Young Adult Appeal for Menthol and Non-menthol Cigarettes
ClinicalTrials.gov ID: NCT04340947
Acronym / sponsor ID: ENHANCE / ENHANCE
Conditions: Cigarette Smoking, Smoking Behaviors
Study type: Interventional
Recruitment status: Completed
Enrolment: 171 participants (actual)
Lead sponsor: University of OklahomaUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Aug 2021 (actual)
Primary completion: 30 Mar 2024 (actual)
Study completion: 30 Apr 2024 (actual)
First posted: 10 Apr 2020 (actual)
Results: Posted 22 Aug 2025

Clinical summary

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

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Menthol very low nicotine cigarette (VLNC), then non-menthol VLNC	Experimental	Other: Very low nicotine cigarette: menthol, Other: Very low nicotine cigarette: non-mentolParticipants will smoke menthol flavored very low nicotine cigarettes in their home environment for 7 days. At the end of 7-days, they will also smoke one menthol flavored very low nicotine cigarette in the laboratory.
Non-menthol very low nicotine cigarette (VLNC), then menthol VLNC	Experimental	Other: Very low nicotine cigarette: menthol, Other: Very low nicotine cigarette: non-mentolParticipants will smoke non-menthol flavored very low nicotine cigarettes in their home environment for 7 days. At the end of 7-days, they will also smoke one non-menthol flavored very low nicotine cigarette in the laboratory.

Who may qualify

Ages: 18 to 34 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Ages18 to 34;
Smoke cigarettes "somedays" or "everyday" for at least the past 3-months;
A strong preference for menthol cigarettes (i.e., smoke menthol >80% of the time); and
Ability to read English at an 8th grade level or higher;
No immediate plans to quit smoking.

Key exclusion criteria (6 listed)

Current use of nicotine replacement therapy (NRT);
Pregnant or planning to become pregnant, or currently breastfeeding;
Past or current self-reported clinically significant heart disease or hypertension, or other smoking-related disease (by history) that preclude successful study completion;
Serious psychiatric disorder;
Inability to abstain from nicotine/tobacco products;

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
Very low nicotine cigarette: mentholParticipants will be randomized to smoke either menthol non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory first and then crossed over to receive the opposite intervention. The study consists of two treatment periods of 7 days separated by a 1 week wash-out period	Other	Menthol very low nicotine cigarette (VLNC), then non-menthol VLNC, Non-menthol very low nicotine cigarette (VLNC), then menthol VLNC
Very low nicotine cigarette: non-mentolParticipants will be randomized to smoke either menthol non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory first and then crossed over to receive the opposite intervention. The study consists of two treatment periods of 7 days separated by a 1 week wash-out period	Other	Menthol very low nicotine cigarette (VLNC), then non-menthol VLNC, Non-menthol very low nicotine cigarette (VLNC), then menthol VLNC

Primary outcome

Puff Topography
Time frame: Baseline to week 4
total inhalation volume from smoking behavior in the laboratory
Ratings of Psychological Reward
Time frame: Baseline to week 9
Subjective response to smoking, as measured by self-reported psychological reward (scale) of the modified Cigarette Evaluation Scale, administered after smoking. The minimum value is 1 and the maximum value is 7; with 7 indicating greater psychological reward.
Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs)
Time frame: Assessed during tobacco purchase tasks completed at week 5
Purchasing of non-menthol very low nicotine cigarettes in the Experimental Tobacco Marketplace (ETM) task 1 and 2. Product units purchased per cigarette price displayed in the ETM, displayed as milligrams of nicotine. Prices are $0.12, $0.25, $0.5, $1, $2, $4, $8, and $16 per cigarette. Data are presented as units purchased on a log scale, per recommended best practices.

1 secondary outcome

Exhaled CO Boost
Time frame: Baseline to week 4

Results and safety

Results posted to the registry on 22 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Menthol Very Low Nicotine Cigarette First	69	69
Non-menthol Very Low Nicotine Cigarette First	70	70

Primary outcome: Puff Topography

Time frame: Baseline to week 4. Mean (Standard Deviation). Unit: mL

Measure	Usual Brand Cigarette n = 111	Menthol Very Low Nicotine Cigarette n = 99	Non-menthol Very Low Nicotine Cigarette n = 103
Value	1108 (1013.7)	1045.2 (1119.4)	1084.6 (1141)

Population analysed: Analysis was restricted to individuals who completed at 2 study visits (of 3 visits). Some individuals were excluded from analysis because of missing smoking data that was not captured by the smoking topography device or several participants who erroneously smoked more than 1 cigarette.

Primary outcome: Ratings of Psychological Reward

Time frame: Baseline to week 9. Mean (Standard Deviation). Unit: score on a scale

Measure	Usual Brand Cigarette n = 111	Menthol Very Low Nicotine Cigarette n = 111	Non-menthol Very Low Nicotine Cigarette n = 111
Value	3.1 (1.30)	2.9 (1.40)	2.3 (1.30)

Population analysed: Population included participants who completed at two study visits and who did not have any missing data on the outcomes

Primary outcome: Hypothetical Purchasing of Non-Menthol Very Low Nicotine Cigarettes (VLNCs)

Time frame: Assessed during tobacco purchase tasks completed at week 5. Mean (Standard Deviation). Unit: log (mg of nicotine)

Measure	Experimental Tobacco Marketplace 1 n = 103	Experimental Tobacco Marketplace 2 n = 103
$0.12	20.40 (36.22)	6.11 (18.38)
$0.25	14.44 (26.64)	3.66 (13.11)
$0.50	10.17 (19.25)	3.37 (12.21)
$1.00	5.68 (14.64)	1.68 (7.21)
$2.00	2.56 (7.56)	1.18 (6.33)
$4.00	1.16 (6.04)	0.34 (1.69)
$8.00	0.44 (2.13)	0.06 (0.43)
$16.00	0.25 (1.51)	0.02 (0.13)

Population analysed: We report raw data on number of non-menthol VLNCs purchased at each price.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 171 (0%)	1 of 171 (0.6%)	0 of 171

Limitations and caveats (from the sponsor): We focused on young adults who smoke menthol cigarettes. Findings may not generalize to non-menthol smokers or to different age groups. We did not include menthol and non-menthol normal nicotine cigarette conditions. Participants were not blinded to the cigarette nicotine content to model real-world conditions where consumers are aware of the cigarettes they smoke.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36410805Cohn AM, Cassidy R, Denlinger-Apte R, Donny E, Villanti AC, Hatsukami D, Dunn D, Wyatt R, Niznik T, Cohen-Davidyan T, Smith M, Ehlke SJ. Impact of a reduced nicotine standard on young adult appeal for menthol and non-menthol cigarettes. BMJ Open. 2022 Nov 21;12(11):e067694. doi: 10.1136/bmjopen-2022-067694.

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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.

Amy Cohn, PhD principal investigator

University of Oklahoma

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

Questions about this trial

What is this clinical trial studying?

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 6 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 22 Aug 2025. 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 22 Aug 2025). 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?

Puff Topography (time frame: Baseline to week 4). The study lists 3 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 NCT04340947, which also lists 1 linked publication.

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 22 Aug 2025.