Tobacco UseNCT03075839
Impact of Switching to Non-Menthol Cigarettes Among Smokers
A study testing Cigarette Brand Switching in people with Tobacco Use, run by Yale University at 1 site in United States.
Trial summary
This pilot study will investigate within-person changes in smoking behavior when current adult smokers are systematically switched from smoking menthol cigarettes to non-menthol cigarettes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Cigarette Brand Switching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2017to 1 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- Able to read English
- Cigarette smoker
Who cannot join
- Seeking smoking cessation treatment
- Serious psychiatric or medical condition
- Use of other drugs
- Unable or unwilling to complete study protocol
Trial locations and contacts
1 site in 1 country.
About this study
This pilot study will investigate within-person changes in smoking behavior when current adult smokers are systematically switched from smoking menthol cigarettes to non-menthol cigarettes.
Read the detailed description
The goals of this project include evaluating the feasibility of a cigarette switching paradigm to examine how switching adult smokers from menthol to non-menthol cigarettes impacts smoking behavior and satisfaction. Smoking behavior will be measured by self-reported total number of cigarettes and time to first cigarette in the morning, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3). Smoking satisfaction will be measured by self-reported ratings of the cigarettes, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3).
- Conditions
- Tobacco Use
- Being tested
- Cigarette Brand Switching
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cigarette Brand SwitchingOther
Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of two weeks
| Study group | Role | What they receive |
|---|---|---|
| Cigarette Brand Switching | Experimental | Adult smokers will be switched from using menthol cigarettes to non-menthol cigarettes Receives: Other: Cigarette Brand Switching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Cigarettes Smoked
Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes
Measured: Menthol smoking (Week 2), Non-menthol smoking (Week 4)
Secondary outcomes (2)
Nicotine Dependence
Self-reported subjective ratings of nicotine dependence after switching to non-menthol cigarettes (measured as change in Wisconsin Inventory of Smoking Dependence Motives (WISDM) total dependence scores). Total range 11-77 with higher scores indicating greater nicotine dependence.
Measured: Week 4 (non-menthol)
Quitting Interest
Self-reported subjective motivation/interest in quitting smoking after switching to non-menthol cigarettes. Measured by the item "how important is quitting smoking to you?" from 1 "not at all" to 10 "extremely".
Measured: Week 4 (non-menthol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start3 Mar 2017
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
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 Tobacco UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Krysten Bold, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075839
- Sponsor's protocol ID
- 2000020334
- Other IDs
- 1P50DA036151-01
- Status last verified
- Feb 2023
- First submitted
- 6 Mar 2017
- Last updated
- 2 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bold KW, Jatlow P, Fucito LM, Eid T, Krishnan-Sarin S, O'Malley S. Evaluating the effect of switching to non-menthol cigarettes among current menthol smokers: an empirical study of a potential ban of characterising menthol flavour in cigarettes. Tob Control. 2020 Nov;29(6):624-630. doi: 10.1136/tobaccocontrol-2019-055154. Epub 2019 Nov 4.
PubMed 31685586
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Switching to Non-Menthol Cigarettes Among Smokers
- ClinicalTrials.gov ID
- NCT03075839
- Acronym / sponsor ID
- 2000020334
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Food and Drug Administration (FDA)
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 17 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will investigate within-person changes in smoking behavior when current adult smokers are systematically switched from smoking menthol cigarettes to non-menthol cigarettes.
Detailed description
The goals of this project include evaluating the feasibility of a cigarette switching paradigm to examine how switching adult smokers from menthol to non-menthol cigarettes impacts smoking behavior and satisfaction. Smoking behavior will be measured by self-reported total number of cigarettes and time to first cigarette in the morning, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3). Smoking satisfaction will be measured by self-reported ratings of the cigarettes, assessed during the period of menthol smoking (week 1) and again after switching to non-menthol cigarettes (weeks 2, 3).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subject design comparing smoking behavior when using menthol vs. non-menthol cigarettes
| Arm | Type | Receives |
|---|---|---|
| Cigarette Brand Switching | Experimental | Other: Cigarette Brand SwitchingAdult smokers will be switched from using menthol cigarettes to non-menthol cigarettes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 or older
- Able to read English
- Cigarette smoker
Key exclusion criteria (4 listed)
- Seeking smoking cessation treatment
- Serious psychiatric or medical condition
- Use of other drugs
- Unable or unwilling to complete study protocol
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 Brand SwitchingAdult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of two weeks | Other | Cigarette Brand Switching |
Primary outcome
Total Number of Cigarettes Smoked
Time frame: Menthol smoking (Week 2), Non-menthol smoking (Week 4)
Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes
2 secondary outcomes
Nicotine Dependence
Time frame: Week 4 (non-menthol)
Quitting Interest
Time frame: Week 4 (non-menthol)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31685586Bold KW, Jatlow P, Fucito LM, Eid T, Krishnan-Sarin S, O'Malley S. Evaluating the effect of switching to non-menthol cigarettes among current menthol smokers: an empirical study of a potential ban of characterising menthol flavour in cigarettes. Tob Control. 2020 Nov;29(6):624-630. doi: 10.1136/tobaccocontrol-2019-055154. Epub 2019 Nov 4.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
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.
Krysten Bold, Ph.D. principal investigator
Yale University
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 Brand Switching in people with Tobacco Use, run by Yale University 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 3 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 2 Mar 2023. 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 17 Apr 2020). 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?
Total Number of Cigarettes Smoked (time frame: Menthol smoking (Week 2), Non-menthol smoking (Week 4)). 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 NCT03075839, 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 2 Mar 2023.