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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
  Purpose
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.

Condition Intervention
Nicotine Dependence Other: Reduced Nicotine Content- Non Menthol Other: Reduced Nicotine Content- Menthol Other: Conventional Nicotine Content- Menthol Other: Conventional Nicotine Content- Non Menthol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Manipulating Tobacco Constituents in Female Menthol Smokers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 320
Study Start Date: July 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Experimental: Reduced Nicotine Content- Menthol
Switch from own brand of cigarette to Reduced Nicotine Research Cigarettes which contain 0.07mg nicotine yield with Menthol
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
Active Comparator: Conventional Nicotine Content- Menthol
Allow own brand of Conventional Nicotine-Menthol Cigarette. No research cigarettes used.
Other: Conventional Nicotine Content- Menthol
Allow own brand of Conventional Nicotine-Menthol Cigarette
Other Name: Own brand of Conventional Nicotine-Menthol Cigarette
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.
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

Detailed Description:

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?
  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:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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): NCT02048852


Contacts
Contact: Cheryl A Oncken, MD. MPH 860-679-3425 Oncken@uchc.edu

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 A Oncken, MD MPH UCONN Health Center
  More Information

Responsible Party: Cheryl Oncken, Professor, UConn Health
ClinicalTrials.gov Identifier: NCT02048852     History of Changes
Other Study ID Numbers: DORN004127HE
1R01DA036486-01 ( U.S. NIH Grant/Contract )
First Submitted: January 27, 2014
First Posted: January 29, 2014
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cheryl Oncken, UConn Health:
menthol
nicotine

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Menthol
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