Manipulating Tobacco Constituents in Male Menthol Smokers

NCT02592772 | Completed DMC

• 2 other identifiers: HHC-2015-01283R01DA036486-02S1
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

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.

Conditions

Nicotine Dependence

Keywords

menthol; nicotine; reduced nicotine; smoking; cigarette; cigarettes; men smoking; smoking research; nicotine dependence

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 6 weeks, and 12 weeks

Secondary Outcomes (4)

• Gender differences and changes in craving as assessed by Minnesota Nicotine Withdrawal Scale (MNWS).

  Baseline, 6 weeks, and 12 weeks

• Gender differences and changes in nicotine dependence as assessed by the Wisconsin Index of Smoking Dependence Motives (WISDM).

  Baseline, 6 weeks, and 12 weeks

• Gender differences and changes in nicotine dependence as assessed by the Fagerstrom Test of Nicotine Dependence (FTND)

  Baseline, 6 weeks, and 12 weeks

• Supertaster status as measured by genotyping for taster-receptor genes associated with taste behaviors.

  Baseline

Study Arms (3)

Reduced Nicotine Non-Menthol (RNC)

EXPERIMENTAL

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.

Other: Reduced Nicotine Non-Menthol (RNC)

Reduced Nicotine Menthol (RNC-Men)

EXPERIMENTAL

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.

Other: Reduced Nicotine Menthol (RNC-Men)

Conventional Nicotine Non-Menthol (CN)

EXPERIMENTAL

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.

Other: Conventional Nicotine Non-Menthol (CN)

Interventions

Reduced Nicotine Non-Menthol (RNC) OTHER

Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield without menthol.

Also known as: SPECTRUM Research Cigarette - NRC 200

Reduced Nicotine Non-Menthol (RNC)

Reduced Nicotine Menthol (RNC-Men) OTHER

Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield with menthol.

Also known as: SPECTRUM Research Cigarette - NRC 201

Reduced Nicotine Menthol (RNC-Men)

Conventional Nicotine Non-Menthol (CN) OTHER

Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.

Also known as: SPECTRUM Research Cigarette - NRC 600

Conventional Nicotine Non-Menthol (CN)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• 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;
• male 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 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

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; Smoking

Condition Hierarchy (Ancestors)

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

Study Officials

• Cheryl Oncken, MD, MPH

  UConn Health

  PRINCIPAL INVESTIGATOR

• Ellen Dornelas, PhD

  Hartford HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 30, 2015
• Study Start: February 4, 2016
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)