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Manipulating Tobacco Constituents in Male Menthol Smokers

Primary Purpose

Nicotine Dependence

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

About this trial

This is an interventional other trial for Nicotine Dependence focused on measuring menthol, nicotine, reduced nicotine, smoking, cigarette, cigarettes, men smoking, smoking research, nicotine dependence

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • UCONN Health Center
  • Hartford Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Reduced Nicotine Non-Menthol (RNC)

Reduced Nicotine Menthol (RNC-Men)

Conventional Nicotine Non-Menthol (CN)

Arm Description

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.

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.

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.

Outcomes

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)
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).
Gender differences and changes in nicotine dependence as assessed by the Wisconsin Index of Smoking Dependence Motives (WISDM).
Gender differences and changes in nicotine dependence as assessed by the Fagerstrom Test of Nicotine Dependence (FTND)
Supertaster status as measured by genotyping for taster-receptor genes associated with taste behaviors.

Full Information

First Posted
October 20, 2015
Last Updated
April 7, 2020
Sponsor
UConn Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02592772
Brief Title
Manipulating Tobacco Constituents in Male Menthol Smokers
Official Title
Manipulating Tobacco Constituents in Male Menthol Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 4, 2016 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
June 2019 (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 men. It will also examine whether there are gender differences in manipulating tobacco flavors and nicotine concentrations in cigarettes on smoking behavior.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
menthol, nicotine, reduced nicotine, smoking, cigarette, cigarettes, men smoking, smoking research, nicotine dependence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reduced Nicotine Non-Menthol (RNC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Reduced Nicotine Menthol (RNC-Men)
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Nicotine Non-Menthol (CN)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Reduced Nicotine Non-Menthol (RNC)
Other Intervention Name(s)
SPECTRUM Research Cigarette - NRC 200
Intervention Description
Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield without menthol.
Intervention Type
Other
Intervention Name(s)
Reduced Nicotine Menthol (RNC-Men)
Other Intervention Name(s)
SPECTRUM Research Cigarette - NRC 201
Intervention Description
Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield with menthol.
Intervention Type
Other
Intervention Name(s)
Conventional Nicotine Non-Menthol (CN)
Other Intervention Name(s)
SPECTRUM Research Cigarette - NRC 600
Intervention Description
Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.
Primary Outcome Measure Information:
Title
Gender differences and change in number of investigational tobacco product(s) smoked per day as assessed by the Timeline Follow-Back (TLFB)
Description
Data analyses will include subjects from this study matched to female subjects from the parent study.
Time Frame
Baseline, 6 weeks, and 12 weeks
Secondary Outcome Measure Information:
Title
Gender differences and changes in craving as assessed by Minnesota Nicotine Withdrawal Scale (MNWS).
Time Frame
Baseline, 6 weeks, and 12 weeks
Title
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
Title
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
Title
Supertaster status as measured by genotyping for taster-receptor genes associated with taste behaviors.
Time Frame
Baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: smoking at least 5 menthol cigarettes daily for the last year; able to speak, read and understand English; male age 18 -45 years of age; stable residence; not intending to quit smoking within the next 6 weeks. Exclusion Criteria: 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.); 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 Serious quit attempts in the last 3 months; regular use (e.g., greater than weekly) of tobacco products other than cigarettes; currently using nicotine replacement or other tobacco cessation products
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Oncken, MD, MPH
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen Dornelas, PhD
Organizational Affiliation
Hartford HealthCare
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 Male Menthol Smokers

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