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Manipulating Tobacco Constituents in Female Menthol Smokers (Menthol)

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reduced Nicotine Content- Non Menthol
Reduced Nicotine Content- Menthol
Conventional Nicotine Content- Menthol
Conventional Nicotine Content- Non Menthol
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Dependence focused on measuring menthol, nicotine

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • UCONN Health Center
  • Hartford Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Experimental

Arm Label

Reduced Nicotine Content -Non Menthol

Reduced Nicotine Content- Menthol

Conventional Nicotine Content- Menthol

Conventional Nicotine Content- Non Menthol

Arm Description

Switch from own brand of cigarette to SPECTRUM research cigarettes (NRC 200-Reduced Nicotine Content cigarette) which contain 0.07mg nicotine yield without menthol.

Switch from own brand of cigarette to Reduced Nicotine Research Cigarettes which contain 0.07mg nicotine yield with Menthol

Allow own brand of Conventional Nicotine-Menthol Cigarette. No research cigarettes used.

Switch from own brand of cigarette to SPECTRUM research cigarette (NRC-600 Conventional Nicotine )which contains conventional nicotine yield.

Outcomes

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.
Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized.

Secondary Outcome Measures

Toxicant Exposure
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.

Full Information

First Posted
January 27, 2014
Last Updated
March 18, 2021
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02048852
Brief Title
Manipulating Tobacco Constituents in Female Menthol Smokers
Acronym
Menthol
Official Title
Manipulating Tobacco Constituents in Female Menthol Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Study is designed to address the following questions that have been outlined by the FDA as particular areas of interest: 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? 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? Beyond nicotine, what other constituents enhance addictive properties?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
menthol, nicotine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduced Nicotine Content -Non Menthol
Arm Type
Experimental
Arm Description
Switch from own brand of cigarette to SPECTRUM research cigarettes (NRC 200-Reduced Nicotine Content cigarette) which contain 0.07mg nicotine yield without menthol.
Arm Title
Reduced Nicotine Content- Menthol
Arm Type
Experimental
Arm Description
Switch from own brand of cigarette to Reduced Nicotine Research Cigarettes which contain 0.07mg nicotine yield with Menthol
Arm Title
Conventional Nicotine Content- Menthol
Arm Type
Active Comparator
Arm Description
Allow own brand of Conventional Nicotine-Menthol Cigarette. No research cigarettes used.
Arm Title
Conventional Nicotine Content- Non Menthol
Arm Type
Experimental
Arm Description
Switch from own brand of cigarette to SPECTRUM research cigarette (NRC-600 Conventional Nicotine )which contains conventional nicotine yield.
Intervention Type
Other
Intervention Name(s)
Reduced Nicotine Content- Non Menthol
Other Intervention Name(s)
SPECTRUM Research Cigarette - NRC 200
Intervention Description
Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.
Intervention Type
Other
Intervention Name(s)
Reduced Nicotine Content- Menthol
Other Intervention Name(s)
SPECTRUM Research Cigarette - RNC 201
Intervention Description
Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol
Intervention Type
Other
Intervention Name(s)
Conventional Nicotine Content- Menthol
Other Intervention Name(s)
Own brand of Conventional Nicotine-Menthol Cigarette
Intervention Description
Allow own brand of Conventional Nicotine-Menthol Cigarette
Intervention Type
Other
Intervention Name(s)
Conventional Nicotine Content- Non Menthol
Other Intervention Name(s)
SPECTRUM Research Cigarette - NRC 600
Intervention Description
Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.
Primary Outcome Measure Information:
Title
The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence.
Description
Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Toxicant Exposure
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Cigarette content manipulations effect on a model mediating usage
Description
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
Time Frame
12 Weeks
Title
Effect of taster status
Description
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.
Time Frame
12 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria are: smoking at least 5 menthol cigarettes daily for the last year; able to speak, read and understand English female age 18 -45 years of age; stable residence; not intending to quit smoking within the next 6 weeks. Exclusion criteria are: 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.); 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 (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; Serious quit attempts in the last 3 months (to ensure stability of smoking); regular use (e.g., greater than weekly) of tobacco products other than cigarettes; Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product); 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl A Oncken, MD MPH
Organizational Affiliation
UCONN Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCONN Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Manipulating Tobacco Constituents in Female Menthol Smokers

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