Nicotine DependenceMentholNCT02048852
Manipulating Tobacco Constituents in Female Menthol Smokers
A study testing Reduced Nicotine Content- Non Menthol, Reduced Nicotine Content- Menthol and Conventional Nicotine Content- Menthol in people with Nicotine Dependence, run by UConn Health at 2 sites in United States.
Trial summary
This study examines the potential effect of reducing nicotine content or menthol or both in women of reproductive age, a vulnerable population identified by the FDA in need of further research. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Reduced Nicotine Content- Non Menthol, Reduced Nicotine Content- Menthol and Conventional Nicotine Content- Menthol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- smoking at least 5 menthol cigarettes daily for the last year;
- able to speak, read and understand English
- female age 18 -45 years of age;
- stable residence;
- not intending to quit smoking within the next 6 weeks.
Who cannot join
- unstable psychiatric disorder (Psychiatric symptoms reported by patient or identified in medical record that cause current significant impairment in functioning or judgment such that the person's ability to come consistently for study appointments or render a decision regarding informed consent is in question.);
- substance use which exceeds any of the following: marijuana use 3x/week, consuming 21 drinks/week or illicit drug use 1x/week;
- history of cardiovascular disease;
- current blood clot in arms or legs;
- blood pressure >160/100;
- unstable medical problems which may include but are not limited to immune system disorders, severe respiratory diseases, kidney or liver diseases, thyroid problems, substance abuse or dependence that would limit patients ability to follow experimental protocol (based on history and drug and alcohol questionaires) or other heart conditions. The study physician will determine whether a given medical condition is unstable and the appropriateness of study participation for a particular subject;
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- Serious quit attempts in the last 3 months (to ensure stability of smoking);
- regular use (e.g., greater than weekly) of tobacco products other than cigarettes;
- Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
- Pregnant or breastfeeding those planning to become pregnant,and those who are of childbearing potential and are not using an "acceptable form" of birthcontrol such as Depo-provera, Norplant, tubal ligation and barrier methods such as condoms or diaphragm.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UCONN Health Center
Farmington, Connecticut, 06030
Hartford Hospital
Hartford, Connecticut, 06102
About this study
This study examines the potential effect of reducing nicotine content or menthol or both in women of reproductive age, a vulnerable population identified by the FDA in need of further research.
Read the detailed description
Study is designed to address the following questions that have been outlined by the FDA as particular areas of interest:
- What are the factors, including menthol and other flavorings that influence the appeal of tobacco products to vulnerable populations: What is the impact of these factors on cessation, switching tobacco products and multiple use?
- What is the potential impact of modifying nicotine levels on dependence, and smoking rate and cessation, as well as patterns of switching products and use of multiple tobacco products?
- Beyond nicotine, what other constituents enhance addictive properties?
- Conditions
- Nicotine Dependence
- Being tested
- Reduced Nicotine Content- Non Menthol, Reduced Nicotine Content- Menthol, Conventional Nicotine Content- Menthol, Conventional Nicotine Content- Non Menthol
- Keywords
- menthol, nicotine
- 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.
Reduced Nicotine Content- Non MentholOther
Also called SPECTRUM Research Cigarette - NRC 200
Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.
Reduced Nicotine Content- MentholOther
Also called SPECTRUM Research Cigarette - RNC 201
Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol
Conventional Nicotine Content- MentholOther
Also called Own brand of Conventional Nicotine-Menthol Cigarette
Allow own brand of Conventional Nicotine-Menthol Cigarette
Conventional Nicotine Content- Non MentholOther
Also called SPECTRUM Research Cigarette - NRC 600
Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Nicotine Content -Non Menthol | Experimental | Switch from own brand of cigarette to SPECTRUM research cigarettes (NRC 200-Reduced Nicotine Content cigarette) which contain 0.07mg nicotine yield without menthol. Receives: Other: Reduced Nicotine Content- Non Menthol |
| Reduced Nicotine Content- Menthol | Experimental | Switch from own brand of cigarette to Reduced Nicotine Research Cigarettes which contain 0.07mg nicotine yield with Menthol Receives: Other: Reduced Nicotine Content- Menthol |
| Conventional Nicotine Content- Menthol | Active comparator | Allow own brand of Conventional Nicotine-Menthol Cigarette. No research cigarettes used. Receives: Other: Conventional Nicotine Content- Menthol |
| Conventional Nicotine Content- Non Menthol | Experimental | Switch from own brand of cigarette to SPECTRUM research cigarette (NRC-600 Conventional Nicotine )which contains conventional nicotine yield. Receives: Other: Conventional Nicotine Content- Non Menthol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence.
Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized.
Measured: 12 weeks
Secondary outcomes (1)
Toxicant Exposure
Examine the effects of reduced nicotine and menthol removal on toxicant exposure for the outcomes-- cotinine, exhaled carbon monoxide, and urine carcinogens and other tobacco specific nitrosamines.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Cheryl A Oncken, MD MPH, Principal investigator, UCONN Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048852
- Sponsor's protocol ID
- H14-120-1
- Other IDs
- 1R01DA036486-01
- Acronym
- Menthol
- Status last verified
- Mar 2021
- First submitted
- 27 Jan 2014
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulating Tobacco Constituents in Female Menthol Smokers
- ClinicalTrials.gov ID
- NCT02048852
- Acronym / sponsor ID
- Menthol / H14-120-1
- Conditions
- Nicotine Dependence
- Keywords
- menthol, nicotine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2014
- Primary completion
- Mar 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 29 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the potential effect of reducing nicotine content or menthol or both in women of reproductive age, a vulnerable population identified by the FDA in need of further research.
Detailed description
Study is designed to address the following questions that have been outlined by the FDA as particular areas of interest:
- What are the factors, including menthol and other flavorings that influence the appeal of tobacco products to vulnerable populations: What is the impact of these factors on cessation, switching tobacco products and multiple use?
- What is the potential impact of modifying nicotine levels on dependence, and smoking rate and cessation, as well as patterns of switching products and use of multiple tobacco products?
- Beyond nicotine, what other constituents enhance addictive properties?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reduced Nicotine Content -Non Menthol | Experimental | Other: Reduced Nicotine Content- Non MentholSwitch from own brand of cigarette to SPECTRUM research cigarettes (NRC 200-Reduced Nicotine Content cigarette) which contain 0.07mg nicotine yield without menthol. |
| Reduced Nicotine Content- Menthol | Experimental | Other: Reduced Nicotine Content- MentholSwitch from own brand of cigarette to Reduced Nicotine Research Cigarettes which contain 0.07mg nicotine yield with Menthol |
| Conventional Nicotine Content- Menthol | Active comparator | Other: Conventional Nicotine Content- MentholAllow own brand of Conventional Nicotine-Menthol Cigarette. No research cigarettes used. |
| Conventional Nicotine Content- Non Menthol | Experimental | Other: Conventional Nicotine Content- Non MentholSwitch from own brand of cigarette to SPECTRUM research cigarette (NRC-600 Conventional Nicotine )which contains conventional nicotine yield. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- smoking at least 5 menthol cigarettes daily for the last year;
- able to speak, read and understand English
- female age 18 -45 years of age;
- stable residence;
- not intending to quit smoking within the next 6 weeks.
Key exclusion criteria (10 listed)
- unstable psychiatric disorder (Psychiatric symptoms reported by patient or identified in medical record that cause current significant impairment in functioning or judgment such that the person's ability to come consistently for study appointments or render a decision regarding informed consent is in question.);
- substance use which exceeds any of the following: marijuana use 3x/week, consuming 21 drinks/week or illicit drug use 1x/week;
- history of cardiovascular disease;
- current blood clot in arms or legs;
- blood pressure >160/100;
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 |
|---|---|---|
| Reduced Nicotine Content- Non MentholAlso: SPECTRUM Research Cigarette - NRC 200Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol. | Other | Reduced Nicotine Content -Non Menthol |
| Reduced Nicotine Content- MentholAlso: SPECTRUM Research Cigarette - RNC 201Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol | Other | Reduced Nicotine Content- Menthol |
| Conventional Nicotine Content- MentholAlso: Own brand of Conventional Nicotine-Menthol CigaretteAllow own brand of Conventional Nicotine-Menthol Cigarette | Other | Conventional Nicotine Content- Menthol |
| Conventional Nicotine Content- Non MentholAlso: SPECTRUM Research Cigarette - NRC 600Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield. | Other | Conventional Nicotine Content- Non Menthol |
Primary outcome
The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence.
Time frame: 12 weeks
Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized.
1 secondary outcome
Toxicant Exposure
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Cheryl A Oncken, MD MPH principal investigator
UCONN Health Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced Nicotine Content- Non Menthol, Reduced Nicotine Content- Menthol and Conventional Nicotine Content- Menthol in people with Nicotine Dependence, run by UConn Health at 2 sites 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 10 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 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.