Manipulating Tobacco Constituents in Female Menthol Smokers (Menthol)

March 18, 2021 updated by: UConn Health
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UCONN Health Center
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • SPECTRUM Research Cigarette - NRC 600

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 Weeks
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.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Cheryl A Oncken, MD MPH, UCONN Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-120-1
  • 1R01DA036486-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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