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Trial record 1 of 1 for:    Manipulating Tobacco Constituents in Female Menthol Smokers
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Manipulating Tobacco Constituents in Female Menthol Smokers (Menthol)

This study is currently recruiting participants.
Verified October 2017 by Cheryl Oncken, UConn Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT02048852
First Posted: January 29, 2014
Last Update Posted: October 26, 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
January 27, 2014
January 29, 2014
October 26, 2017
July 2014
September 2018   (Final data collection date for 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 ]
Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized.
Same as current
Complete list of historical versions of study NCT02048852 on ClinicalTrials.gov Archive Site
Toxicant Exposure [ Time Frame: 12 weeks ]
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.
Toxicant Exposure [ Time Frame: 12 weeks ]
Examine the effects of reduced nicotine and menthol removal on toxicant exposure for the outcomes-- cotinine, exhaled carbon monoxide, and NNAL and other tobacco specific nitrosamines.
  • Cigarette content manipulations effect on a model mediating usage [ Time Frame: 12 Weeks ]
    Examine cigarette content manipulation (nicotine reduction and menthol removal) as independent variables and the number of cigarettes recorded daily as dependent variable..Measures that will be tested for include subscales of the cigarette evaluations as well as craving, affect and mood, and self-confidence
  • Effect of taster status [ Time Frame: 12 Weeks ]
    To explore the moderating effects of supertasters with menthol assignments to predict compliance with treatment, cigarette taste and aversion. A logistic model will be used to predict post-treatment abstinence. The interaction between supertaster and menthol will test for the moderating effect.
Same as current
 
Manipulating Tobacco Constituents in Female Menthol Smokers
Manipulating Tobacco Constituents in Female Menthol Smokers
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.

Study is designed to address the following questions that have been outlined by the FDA as particular areas of interest:

  1. 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?
  2. 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?
  3. Beyond nicotine, what other constituents enhance addictive properties?
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Nicotine Dependence
  • Other: Reduced Nicotine Content- Non Menthol
    Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.
    Other Name: SPECTRUM Research Cigarette - NRC 200
  • Other: Reduced Nicotine Content- Menthol
    Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol
    Other Name: SPECTRUM Research Cigarette - RNC 201
  • Other: Conventional Nicotine Content- Menthol
    Allow own brand of Conventional Nicotine-Menthol Cigarette
    Other Name: Own brand of Conventional Nicotine-Menthol Cigarette
  • Other: Conventional Nicotine Content- Non Menthol
    Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.
    Other Name: SPECTRUM Research Cigarette - NRC 600
  • Experimental: Reduced Nicotine Content -Non Menthol
    Switch from own brand of cigarette to SPECTRUM research cigarettes (NRC 200-Reduced Nicotine Content cigarette) which contain 0.07mg nicotine yield without menthol.
    Intervention: Other: Reduced Nicotine Content- Non Menthol
  • Experimental: Reduced Nicotine Content- Menthol
    Switch from own brand of cigarette to Reduced Nicotine Research Cigarettes which contain 0.07mg nicotine yield with Menthol
    Intervention: Other: Reduced Nicotine Content- Menthol
  • Active Comparator: Conventional Nicotine Content- Menthol
    Allow own brand of Conventional Nicotine-Menthol Cigarette. No research cigarettes used.
    Intervention: Other: Conventional Nicotine Content- Menthol
  • Experimental: Conventional Nicotine Content- Non Menthol
    Switch from own brand of cigarette to SPECTRUM research cigarette (NRC-600 Conventional Nicotine )which contains conventional nicotine yield.
    Intervention: Other: Conventional Nicotine Content- Non Menthol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
320
December 2018
September 2018   (Final data collection date for primary outcome measure)

Inclusion criteria are:

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

Exclusion criteria are:

  1. 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.);
  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 (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;
  7. Serious quit attempts in the last 3 months (to ensure stability of smoking);
  8. regular use (e.g., greater than weekly) of tobacco products other than cigarettes;
  9. Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product);
  10. 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.
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact: Cheryl A Oncken, MD. MPH 860-679-3425 Oncken@uchc.edu
United States
 
 
NCT02048852
DORN004127HE
1R01DA036486-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
Cheryl Oncken, UConn Health
UConn Health
National Institute on Drug Abuse (NIDA)
Principal Investigator: Cheryl A Oncken, MD MPH UCONN Health Center
UConn Health
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP