Smoking, CigarettePRISMNCT03953508

Perceptions of Cigarette Smoking in Young Adults

A study testing Cigarette flavor type in people with Smoking, Cigarette, 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

Search all trials

Trial summary

This study focuses on menthol (n = 125) and non-menthol (n = 125) smoking young adults (YAs; defined here as ages 18 to 26). Read more about this study

Who is it for?: Ages 18 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Smoking, Cigarette
What is being tested?: Cigarette flavor type
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2020to 31 Jan 2023
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 26 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Ages 18-26
Currently smoke cigarettes "everyday" or "somedays"
A strong preference for menthol or non-menthol cigarettes
able to read and understand the consent form
willingness to abstain from nicotine or tobacco products for at least 12 hours prior to smoking sessions

Who cannot join

Current use of nicotine replacement therapy
Pregnant or planning to become pregnant; or breastfeeding
self-reported diagnosis of lung disease, including asthma, cystic fibrosis, or chronic obstructive pulmonary disease; or
self-reported history of cardiac event or distress within the past 3-months

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: Menthol and Non-Menthol Cigarette Smoking in Young Adults

This study focuses on menthol (n = 125) and non-menthol (n = 125) smoking young adults (YAs; defined here as ages 18 to 26).

Read the detailed description

The study will occur in three phases.

In session 1 of Phase 1, participants will engage in ad libitum smoking session of one's preferred cigarette brand (menthol or non-menthol). In session 2, participants will take several puffs each of a commercially available menthol and non-menthol cigarette (i.e., Camel Crush) and complete a complete a series of pre-post smoking questionnaires, and in Session 3 participants will complete a computerized task to measure perceptions of cigarette smoking. For the computerized task, participants will be able to "win" points toward earning puffs of a cigarette and will be able to smoke puffs earned. Participants will be asked to abstain from smoking for at least 12 hours before each in-person visit.

Phase 2 participants will engage in 14 days of surveys they will complete on their cell to measure different aspects of smoking behavior. These surveys will happen twice a day at random times.

For phase 3, participants will complete an assessment of smoking behavior and related factors 6-months after the baseline assessment either in-person, in the laboratory, or via telephone or online (if in-person follow-up is not viable).

The order in which phases occur differed was a result of COVID-19 restrictions on data collection. For some participants, they started EMA first and then began laboratory data collection when in-person was allowed. For others, they started laboratory data collection when COVID restrictions were lifted. Thus, the participant flow may appear unbalanced.

Conditions: Smoking, Cigarette
Being tested: Cigarette flavor type
Medical subject headings: Cigarette Smoking

What participants receive

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

Cigarette flavor typeOther
Also called Experimental cigarette smoking
Participants will smoke several puffs (each) of a menthol Camel Crush and several puffs of a non-menthol Camel Crush cigarette.

Study groups in NCT03953508
Study group	Role	What they receive
Menthol	Other	Participants who prefer smoking menthol cigarettes Receives: Other: Cigarette flavor type
Non-menthol	Other	Participants who prefer smoking non-menthol cigarettes Receives: Other: Cigarette flavor type

What is being measured

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

Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale
ratings of subjective satisfaction from smoking cigarettes, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. The minimum score is 1and the maximum score is 7.
Measured: immediately after smoking usual brand cigarette, at baseline
Average Daily Subjective Response From Smoking
average daily scores of subjective reward from smoking from daily diary surveys, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. Averaged across 14 days.
Measured: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes)
Participants completed a choice task assessing willingness to "work" to click targets on a computer screen to earn menthol or non-menthol cigarette puffs. The relative reinforcing value for menthol was defined by the Breakpoint, or the highest trial (out of 10 trials) completed for a menthol cigarette puff.
Measured: Lab session 3 (estimated average 1-4 weeks after baseline)
Past 30-day Cigarette Smoking Frequency
Number of days smoked cigarettes in the past 30-days
Measured: 6-month follow-up survey (6-months post-baseline)
Puff Topography
Number of cigarette puffs after smoking one's preferred brand/flavor during lab session 1, Phase 1.
Measured: Laboratory session 1 (up to 4 weeks after baseline)

Secondary outcomes (5)

Number of Clicks for Menthol Cigarette Puffs on the Behavioral Choice Task
This outcome represents the total number of clicks (over 10 trials) for the menthol cigarette puff on the behavioral choice task. The reinforcement schedule to click/earn a menthol cigarette puff increased progressively by 25 clicks at each trial such that 25, 50, 75, 100, 125, 150, 175, 200, 225, and 250 clicks of the menthol cigarette image on a computer screen had to be achieved to earn a menthol puff at each trial (maximum possible of 1375 clicks over the task for menthol puffs). All puffs were taken once the entire task was completed (after all 10 trials were done).
Measured: immediately after completing the behavioral economic choice task, lab session 3 (estimated average 1-4 weeks after baseline)
Quantity of Past 30-day Tobacco Product Use
Number of tobacco products used in the past 30-days
Measured: 6-month follow-up (6-months post-baseline)
Number of Participants With Intentions to Smoke Menthol Cigarettes
Number of participants who self-reported intentions to smoke menthol cigarettes assessed via a questionnaire
Measured: 6-month follow-up (6-months post-baseline)
Cigarettes Per Day
Daily report of numbers of cigarettes smoked per day, over 14 days
Measured: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
Average Daily Craving From Smoking
Average daily cigarette craving, aggregated over 14 days, from a 1-item questionnaire measure that was administered daily. Scores range from 0 = not at all to 4 = extremely, where higher scores indicate greater craving intensity.
Measured: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)

Timeline

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

1 Aug 202031 Jan 2023

First posted16 May 2019
Study start1 Aug 2020
Primary completion31 Dec 2022
Study completion31 Jan 2023

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 (2)Papers the sponsor has linked to this study.
Other trials for Smoking, CigaretteStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03953508
Sponsor's protocol ID: PRISM
Acronym: PRISM
Status last verified: Oct 2024
First submitted: 13 May 2019
Last updated: 16 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cohn AM, Elmasry H, Niznik T, Pickworth W, Smith MA, Margaritis WD, Wyatt R, Dunn D, Hedeker D, Murphy J, Audrain-McGovern J, Villanti AC. Racial and ethnic differences in topography and subjective effects among young adults in response to smoking their usual brand menthol or nonmenthol cigarette. Exp Clin Psychopharmacol. 2025 Apr;33(2):145-154. doi: 10.1037/pha0000765. Epub 2025 Feb 24.
PubMed 39992758
Cohn AM, Pickworth W, Audrain-McGovern J, Murphy J, Villanti AC, Hedeker D, Dunn D, Wyatt R, Niznik T, Cotten W, Smith M, Ehlke SJ. Measuring young adult appeal for menthol and non-menthol cigarettes: protocol of a clinical trial using both laboratory and intensive longitudinal methods (PRISM). BMJ Open. 2022 Apr 28;12(4):e058823. doi: 10.1136/bmjopen-2021-058823.
PubMed 35487522

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

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Active, not recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Smoking

All Smoking, Cigarette trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Menthol and Non-Menthol Cigarette Smoking in Young Adults
ClinicalTrials.gov ID: NCT03953508
Acronym / sponsor ID: PRISM / PRISM
Conditions: Smoking, Cigarette
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: University of OklahomaUniversity, hospital or other
Study start: 1 Aug 2020 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Jan 2023 (actual)
First posted: 16 May 2019 (actual)
Results: Posted 16 Dec 2024

Clinical summary

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

This study focuses on menthol (n = 125) and non-menthol (n = 125) smoking young adults (YAs; defined here as ages 18 to 26).

Detailed description

The study will occur in three phases.

Phase 2 participants will engage in 14 days of surveys they will complete on their cell to measure different aspects of smoking behavior. These surveys will happen twice a day at random times.

Study design

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

Arm	Type	Receives
Menthol	Other	Other: Cigarette flavor typeParticipants who prefer smoking menthol cigarettes
Non-menthol	Other	Other: Cigarette flavor typeParticipants who prefer smoking non-menthol cigarettes

Who may qualify

Ages: 18 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Ages 18-26
Currently smoke cigarettes "everyday" or "somedays"
A strong preference for menthol or non-menthol cigarettes
able to read and understand the consent form
willingness to abstain from nicotine or tobacco products for at least 12 hours prior to smoking sessions

Key exclusion criteria (4 listed)

Current use of nicotine replacement therapy
Pregnant or planning to become pregnant; or breastfeeding
self-reported diagnosis of lung disease, including asthma, cystic fibrosis, or chronic obstructive pulmonary disease; or
self-reported history of cardiac event or distress within the past 3-months

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
Cigarette flavor typeAlso: Experimental cigarette smokingParticipants will smoke several puffs (each) of a menthol Camel Crush and several puffs of a non-menthol Camel Crush cigarette.	Other	Menthol, Non-menthol

Primary outcome

Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale
Time frame: immediately after smoking usual brand cigarette, at baseline
ratings of subjective satisfaction from smoking cigarettes, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. The minimum score is 1and the maximum score is 7.
Average Daily Subjective Response From Smoking
Time frame: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
average daily scores of subjective reward from smoking from daily diary surveys, 1= not at all to 7 = extremely. Higher scores indicate greater positive subjective response. Averaged across 14 days.
Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes)
Time frame: Lab session 3 (estimated average 1-4 weeks after baseline)
Participants completed a choice task assessing willingness to "work" to click targets on a computer screen to earn menthol or non-menthol cigarette puffs. The relative reinforcing value for menthol was defined by the Breakpoint, or the highest trial (out of 10 trials) completed for a menthol cigarette puff.
Past 30-day Cigarette Smoking Frequency
Time frame: 6-month follow-up survey (6-months post-baseline)
Number of days smoked cigarettes in the past 30-days
Puff Topography
Time frame: Laboratory session 1 (up to 4 weeks after baseline)
Number of cigarette puffs after smoking one's preferred brand/flavor during lab session 1, Phase 1.

5 secondary outcomes

Number of Clicks for Menthol Cigarette Puffs on the Behavioral Choice Task
Time frame: immediately after completing the behavioral economic choice task, lab session 3 (estimated average 1-4 weeks after baseline)
Quantity of Past 30-day Tobacco Product Use
Time frame: 6-month follow-up (6-months post-baseline)
Number of Participants With Intentions to Smoke Menthol Cigarettes
Time frame: 6-month follow-up (6-months post-baseline)
Cigarettes Per Day
Time frame: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)
Average Daily Craving From Smoking
Time frame: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline)

Results and safety

Results posted to the registry on 16 Dec 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
Menthol Status	95	92
Non-menthol Status	104	102

Primary outcome: Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale

Time frame: immediately after smoking usual brand cigarette, at baseline. Mean (Standard Error). Unit: score on a scale

Measure	Menthol n = 60	Non-menthol n = 61
Value	4.68 (0.16)	4.50 (0.16)

Menthol vs Non-menthol: p >.05, ANCOVA

Population analysed: Young adult menthol and non-menthol smokers, ages 18-26 who completed the baseline/first study visit

Primary outcome: Average Daily Subjective Response From Smoking

Time frame: Phase 2 daily diary surveys (estimated 2-4 weeks after baseline). Mean (Standard Deviation). Unit: average daily scores

Measure	Most Recent Cigarette Was Non-menthol n = 62	Most Recent Cigarette Was Menthol n = 62
Value	1.68 (0.98)	1.79 (0.86)

Most Recent Cigarette Was Non-menthol vs Most Recent Cigarette Was Menthol: p >.05, t-test, 2 sided

Population analysed: Young adult menthol and non-menthol smokers who reported on their daily cigarette smoking during 14-days of ecological momentary assessment

Primary outcome: Highest Trial Competed for a Menthol Cigarette Puff in the Choice Task (Relative Reinforcing Value for Menthol Cigarettes)

Time frame: Lab session 3 (estimated average 1-4 weeks after baseline). Mean (Standard Deviation). Unit: highest trial competed for menthol puffs

Measure	Menthol Status n = 54	Non-menthol Status n = 53
Value	9.2 (2.05)	0.83 (2.47)

Menthol Status vs Non-menthol Status: p <.05, ANOVA

Population analysed: young adult cigarette smokers ages 18-26 who completed the third of three laboratory sessions

Primary outcome: Past 30-day Cigarette Smoking Frequency

Time frame: 6-month follow-up survey (6-months post-baseline). Mean (Standard Deviation). Unit: days

Measure	Menthol Status n = 24	Non-menthol Status n = 31
Value	20.8 (11.9)	20.7 (11.4)

Menthol Status vs Non-menthol Status: p <.05, t-test, 2 sided

Population analysed: Young adult smokers ages 18-26 who completed the 6-month follow-up survey

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected for the entirety of study participation; approximately 6 months.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Menthol Status	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Non-menthol Status	0 of 61 (0%)	1 of 61 (1.6%)	0 of 61

Limitations and caveats (from the sponsor): Data were collected during the COVID-19 pandemic, during times when there were complete or intermittent shut-downs in-person data collection. This resulted in some changes to the order of administration of the study periods/phases in the protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39992758Cohn AM, Elmasry H, Niznik T, Pickworth W, Smith MA, Margaritis WD, Wyatt R, Dunn D, Hedeker D, Murphy J, Audrain-McGovern J, Villanti AC. Racial and ethnic differences in topography and subjective effects among young adults in response to smoking their usual brand menthol or nonmenthol cigarette. Exp Clin Psychopharmacol. 2025 Apr;33(2):145-154. doi: 10.1037/pha0000765. Epub 2025 Feb 24.
Derived from this study: PubMed 35487522Cohn AM, Pickworth W, Audrain-McGovern J, Murphy J, Villanti AC, Hedeker D, Dunn D, Wyatt R, Niznik T, Cotten W, Smith M, Ehlke SJ. Measuring young adult appeal for menthol and non-menthol cigarettes: protocol of a clinical trial using both laboratory and intensive longitudinal methods (PRISM). BMJ Open. 2022 Apr 28;12(4):e058823. doi: 10.1136/bmjopen-2021-058823.
Individual participant dataSharing planned: No

Related trials for Smoking, Cigarette

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Active, not recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Smoking

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?

A study testing Cigarette flavor type in people with Smoking, Cigarette, run by University of Oklahoma 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 16 Dec 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 16 Dec 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?

Subjective Response to Smoking Cigarettes From the Cigarette Evaluation Scale (time frame: immediately after smoking usual brand cigarette, at baseline). The study lists 5 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 NCT03953508, which also lists 2 linked publications.

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 16 Dec 2024.