Nicotine DependenceNCT02592772
Manipulating Tobacco Constituents in Male Menthol Smokers
A study testing Reduced Nicotine Non-Menthol (RNC), Reduced Nicotine Menthol (RNC-Men) and Conventional Nicotine Non-Menthol (CN) 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 men. It will also examine whether there are gender differences in manipulating tobacco flavors and nicotine concentrations in cigarettes on smoking behavior. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Reduced Nicotine Non-Menthol (RNC), Reduced Nicotine Menthol (RNC-Men) and Conventional Nicotine Non-Menthol (CN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Feb 2016to Jun 2019
- 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
- Men 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;
- male 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 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
Show all 9Show fewer
- Serious quit attempts in the last 3 months;
- regular use (e.g., greater than weekly) of tobacco products other than cigarettes;
- currently using nicotine replacement or other tobacco cessation products
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 men. It will also examine whether there are gender differences in manipulating tobacco flavors and nicotine concentrations in cigarettes on smoking behavior.
Read the detailed description
The FDA has the regulatory authority to reduce, but not eliminate, nicotine from cigarettes. The Tobacco Products Scientific Advisory Committee has noted, among other things, that removal of menthol cigarettes from the marketplace would benefit the public health. A parent study (NCT02048852) examines the potential impact of these two regulatory actions alone and in combination in female menthol smokers. This supplemental study will recruit an additional group of male menthol smokers, which will examine whether there are gender differences in manipulating flavors and nicotine concentrations in cigarettes on smoking behavior. The approach to add the opposite sex allows findings of sex/gender to be incorporated in the design and development of new technologies (i.e., modified cigarettes). Emerging research shows that women may be more responsive to the non-nicotine sensory aspects of smoking such as menthol flavor, whereas men may smoke primarily for nicotine intake. Consequently, this study expects to observe gender differences in response to manipulating flavors and nicotine content in cigarettes.
- Conditions
- Nicotine Dependence
- Being tested
- Reduced Nicotine Non-Menthol (RNC), Reduced Nicotine Menthol (RNC-Men), Conventional Nicotine Non-Menthol (CN)
- Keywords
- menthol, nicotine, reduced nicotine, smoking, cigarette, cigarettes, men smoking, smoking research, nicotine dependence
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Nicotine Non-Menthol (RNC)Other
Also called SPECTRUM Research Cigarette - NRC 200
Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield without menthol.
Reduced Nicotine Menthol (RNC-Men)Other
Also called SPECTRUM Research Cigarette - NRC 201
Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield with menthol.
Conventional Nicotine Non-Menthol (CN)Other
Also called SPECTRUM Research Cigarette - NRC 600
Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.
| Study group | Role | What they receive |
|---|---|---|
| Reduced Nicotine Non-Menthol (RNC) | Experimental | Study participants will be randomized from their own brand of menthol cigarettes to the reduced nicotine non menthol cigarettes (RNC: NRC 200; 0.07 mg nicotine yield cigarettes without menthol) during the 6 week experimental phase. Receives: Other: Reduced Nicotine Non-Menthol (RNC) |
| Reduced Nicotine Menthol (RNC-Men) | Experimental | Study participants will be randomized from their own brand of menthol cigarettes to the reduced nicotine menthol cigarettes (RNC-Men: NRC 201; 0.07 mg reduced nicotine content menthol cigarettes) during the 6 week experimental phase. Receives: Other: Reduced Nicotine Menthol (RNC-Men) |
| Conventional Nicotine Non-Menthol (CN) | Experimental | Study participants will be randomized from their own brand of menthol cigarettes to the regular/conventional nicotine non menthol cigarettes (CN: NRC 600; 0.8 mg nicotine content) during the 6 week experimental phase. Receives: Other: Conventional Nicotine Non-Menthol (CN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender differences and change in number of investigational tobacco product(s) smoked per day as assessed by the Timeline Follow-Back (TLFB)
Data analyses will include subjects from this study matched to female subjects from the parent study.
Measured: Baseline, 6 weeks, and 12 weeks
Secondary outcomes (4)
Gender differences and changes in craving as assessed by Minnesota Nicotine Withdrawal Scale (MNWS).
Measured: Baseline, 6 weeks, and 12 weeks
Gender differences and changes in nicotine dependence as assessed by the Wisconsin Index of Smoking Dependence Motives (WISDM).
Measured: Baseline, 6 weeks, and 12 weeks
Gender differences and changes in nicotine dependence as assessed by the Fagerstrom Test of Nicotine Dependence (FTND)
Measured: Baseline, 6 weeks, and 12 weeks
Supertaster status as measured by genotyping for taster-receptor genes associated with taste behaviors.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start4 Feb 2016
- Primary completionMay 2019
- Study completionJun 2019
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 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 Oncken, MD, MPH, Principal investigator, UConn HealthEllen Dornelas, PhD, Principal investigator, Hartford HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592772
- Sponsor's protocol ID
- HHC-2015-0128
- Other IDs
- 3R01DA036486-02S1
- Status last verified
- Apr 2020
- First submitted
- 20 Oct 2015
- Last updated
- 9 Apr 2020
- 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 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulating Tobacco Constituents in Male Menthol Smokers
- ClinicalTrials.gov ID
- NCT02592772
- Acronym / sponsor ID
- HHC-2015-0128
- Conditions
- Nicotine Dependence
- Keywords
- menthol, nicotine, reduced nicotine, smoking, cigarette, cigarettes, men smoking, smoking research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 Feb 2016 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 30 Oct 2015 (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 men. It will also examine whether there are gender differences in manipulating tobacco flavors and nicotine concentrations in cigarettes on smoking behavior.
Detailed description
The FDA has the regulatory authority to reduce, but not eliminate, nicotine from cigarettes. The Tobacco Products Scientific Advisory Committee has noted, among other things, that removal of menthol cigarettes from the marketplace would benefit the public health. A parent study (NCT02048852) examines the potential impact of these two regulatory actions alone and in combination in female menthol smokers. This supplemental study will recruit an additional group of male menthol smokers, which will examine whether there are gender differences in manipulating flavors and nicotine concentrations in cigarettes on smoking behavior. The approach to add the opposite sex allows findings of sex/gender to be incorporated in the design and development of new technologies (i.e., modified cigarettes). Emerging research shows that women may be more responsive to the non-nicotine sensory aspects of smoking such as menthol flavor, whereas men may smoke primarily for nicotine intake. Consequently, this study expects to observe gender differences in response to manipulating flavors and nicotine content in cigarettes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reduced Nicotine Non-Menthol (RNC) | Experimental | Other: Reduced Nicotine Non-Menthol (RNC)Study participants will be randomized from their own brand of menthol cigarettes to the reduced nicotine non menthol cigarettes (RNC: NRC 200; 0.07 mg nicotine yield cigarettes without menthol) during the 6 week experimental phase. |
| Reduced Nicotine Menthol (RNC-Men) | Experimental | Other: Reduced Nicotine Menthol (RNC-Men)Study participants will be randomized from their own brand of menthol cigarettes to the reduced nicotine menthol cigarettes (RNC-Men: NRC 201; 0.07 mg reduced nicotine content menthol cigarettes) during the 6 week experimental phase. |
| Conventional Nicotine Non-Menthol (CN) | Experimental | Other: Conventional Nicotine Non-Menthol (CN)Study participants will be randomized from their own brand of menthol cigarettes to the regular/conventional nicotine non menthol cigarettes (CN: NRC 600; 0.8 mg nicotine content) during the 6 week experimental phase. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male 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;
- male age 18 -45 years of age;
- stable residence;
- not intending to quit smoking within the next 6 weeks.
Key exclusion criteria (9 listed)
- unstable psychiatric disorder (Psychiatric symptoms reported 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 Non-Menthol (RNC)Also: SPECTRUM Research Cigarette - NRC 200Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield without menthol. | Other | Reduced Nicotine Non-Menthol (RNC) |
| Reduced Nicotine Menthol (RNC-Men)Also: SPECTRUM Research Cigarette - NRC 201Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield with menthol. | Other | Reduced Nicotine Menthol (RNC-Men) |
| Conventional Nicotine Non-Menthol (CN)Also: SPECTRUM Research Cigarette - NRC 600Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield. | Other | Conventional Nicotine Non-Menthol (CN) |
Primary outcome
Gender differences and change in number of investigational tobacco product(s) smoked per day as assessed by the Timeline Follow-Back (TLFB)
Time frame: Baseline, 6 weeks, and 12 weeks
Data analyses will include subjects from this study matched to female subjects from the parent study.
4 secondary outcomes
Gender differences and changes in craving as assessed by Minnesota Nicotine Withdrawal Scale (MNWS).
Time frame: Baseline, 6 weeks, and 12 weeks
Gender differences and changes in nicotine dependence as assessed by the Wisconsin Index of Smoking Dependence Motives (WISDM).
Time frame: Baseline, 6 weeks, and 12 weeks
Gender differences and changes in nicotine dependence as assessed by the Fagerstrom Test of Nicotine Dependence (FTND)
Time frame: Baseline, 6 weeks, and 12 weeks
Supertaster status as measured by genotyping for taster-receptor genes associated with taste behaviors.
Time frame: Baseline
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 9 Apr 2020.
- 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 Oncken, MD, MPH principal investigator
UConn Health
Ellen Dornelas, PhD principal investigator
Hartford HealthCare
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 Non-Menthol (RNC), Reduced Nicotine Menthol (RNC-Men) and Conventional Nicotine Non-Menthol (CN) 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 9 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 9 Apr 2020. 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?
Gender differences and change in number of investigational tobacco product(s) smoked per day as assessed by the Timeline Follow-Back (TLFB) (time frame: Baseline, 6 weeks, and 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 9 Apr 2020.