Manipulating Tobacco Constituents in Female Menthol Smokers

NCT02048852 | Completed DMC

• 2 other identifiers: H14-120-11R01DA036486-01
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 2

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.

Conditions

Nicotine Dependence

Keywords

menthol; nicotine

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Toxicant Exposure

  12 weeks

Other Outcomes (2)

• Cigarette content manipulations effect on a model mediating usage

  12 Weeks

• Effect of taster status

  12 Weeks

Study Arms (4)

Reduced Nicotine Content -Non Menthol

EXPERIMENTAL

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

Reduced Nicotine Content- Menthol

EXPERIMENTAL

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

Other: Reduced Nicotine Content- Menthol

Conventional Nicotine Content- Menthol

ACTIVE COMPARATOR

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

Other: Conventional Nicotine Content- Menthol

Conventional Nicotine Content- Non Menthol

EXPERIMENTAL

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

Interventions

Reduced Nicotine Content- Non Menthol OTHER

Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.

Also known as: SPECTRUM Research Cigarette - NRC 200

Reduced Nicotine Content -Non Menthol

Reduced Nicotine Content- Menthol OTHER

Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol

Also known as: SPECTRUM Research Cigarette - RNC 201

Reduced Nicotine Content- Menthol

Conventional Nicotine Content- Menthol OTHER

Allow own brand of Conventional Nicotine-Menthol Cigarette

Also known as: Own brand of Conventional Nicotine-Menthol Cigarette

Conventional Nicotine Content- Menthol

Conventional Nicotine Content- Non Menthol OTHER

Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.

Also known as: SPECTRUM Research Cigarette - NRC 600

Conventional Nicotine Content- Non Menthol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

UCONN Health Center

Farmington, Connecticut, 06030, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Cheryl A Oncken, MD MPH

  UCONN Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 29, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)