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Trial record 1 of 1 for:    Tobacco Constituents in Male Menthol Smokers
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Manipulating Tobacco Constituents in Male Menthol Smokers

This study is currently recruiting participants.
Verified August 2017 by Cheryl Oncken, UConn Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT02592772
First Posted: October 30, 2015
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Cheryl Oncken, UConn Health
  Purpose
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.

Condition Intervention
Nicotine Dependence Other: Reduced Nicotine Non-Menthol (RNC) Other: Reduced Nicotine Menthol (RNC-Men) Other: Conventional Nicotine Non-Menthol (CN)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Manipulating Tobacco Constituents in Male Menthol Smokers

Resource links provided by NLM:


Further study details as provided by Cheryl Oncken, UConn Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 57
Study Start Date: December 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Reduced Nicotine Non-Menthol (RNC)
Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield without menthol.
Other Name: SPECTRUM Research Cigarette - NRC 200
Experimental: 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.
Other: Reduced Nicotine Menthol (RNC-Men)
Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield with menthol.
Other Name: SPECTRUM Research Cigarette - NRC 201
Experimental: 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.
Other: Conventional Nicotine Non-Menthol (CN)
Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.
Other Name: SPECTRUM Research Cigarette - NRC 600

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. smoking at least 5 menthol cigarettes daily for the last year;
  2. able to speak, read and understand English;
  3. male age 18 -45 years of age;
  4. stable residence;
  5. not intending to quit smoking within the next 6 weeks.

Exclusion Criteria:

  1. 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.);
  2. substance use which exceeds any of the following: marijuana use 3x/week, consuming 21 drinks/week or illicit drug use 1x/week;
  3. history of cardiovascular disease;
  4. current blood clot in arms or legs;
  5. blood pressure >160/100;
  6. 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
  7. Serious quit attempts in the last 3 months;
  8. regular use (e.g., greater than weekly) of tobacco products other than cigarettes;
  9. currently using nicotine replacement or other tobacco cessation products
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592772


Contacts
Contact: Vanessa Barber (860) 679-1751 vbarber@uchc.edu
Contact: Lindsay Lorson (860) 972-1295 lindsay.lorson@hhchealth.org

Locations
United States, Connecticut
UCONN Health Center Recruiting
Farmington, Connecticut, United States, 06030
Contact: Sheila Thurlow, MSN    860-679-4637    thurlow@uchc.edu   
Principal Investigator: Cheryl A. Oncken, MD MPH         
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Brianna Liquori    860-972-2399    Brianna.Liquori@hhchealth.org   
Sub-Investigator: Ellen Dornelas, PhD         
Sponsors and Collaborators
UConn Health
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Cheryl Oncken, MD, MPH UConn Health
Principal Investigator: Ellen Dornelas, PhD Hartford HealthCare
  More Information

Responsible Party: Cheryl Oncken, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT02592772     History of Changes
Other Study ID Numbers: HHC-2015-0128
3R01DA036486-02S1 ( U.S. NIH Grant/Contract )
First Submitted: October 20, 2015
First Posted: October 30, 2015
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cheryl Oncken, UConn Health:
menthol
nicotine
reduced nicotine
smoking
cigarette
cigarettes
men smoking
smoking research
nicotine dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Menthol
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents