Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04092387
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Johns Hopkins University
Information provided by (Responsible Party):
Stephen T. Higgins, PhD, University of Vermont

Brief Summary:

Despite marked reductions in cigarette smoking in the general population, smoking rates among economically disadvantaged women have increased. Smoking among women of reproductive age is a particular concern because in addition to the usual health risks, there are additional risks should they become pregnant. A national nicotine reduction policy for cigarettes has considerable potential to reduce tobacco use, dependence, and improve health in these smokers. Controlled trials in general population samples have demonstrated that reducing the nicotine content in cigarettes can reduce cigarettes per day (CPD), dependence severity, and tobacco toxicant exposure.

The goal of the proposed trial is to experimentally examine whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) moderates the effects of altering the nicotine in cigarettes in non-pregnant female cigarette smokers of childbearing age. Additionally, we will test whether allowing participants to personalize the flavor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking.

Daily smokers who are female, aged 18-44 years, and have a maximum educational attainment of graduating high school, will be recruited at Johns Hopkins University and the University of Vermont.

We will study two research cigarettes referred to here as RC1 and RC2. One of these cigarettes will be a normal nicotine content cigarette and the other will be a reduced nicotine content cigarette. We will study two e-cigarette conditions referred to here as EC1 and EC2. Both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other condition that e-liquid will be available in multiple flavors from which participants can choose based on personal taste preference. Participants will be assigned to one of the following four study conditions: (1) RC1 only; (2) RC2 only; (3) RC2 + EC1; (4) RC2 + EC2.

Participants will be asked to use only their assigned study products for 16 weeks. Outcome measures include total CPD, cigarette demand assessed by behavioral economics-based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), biomarkers of tobacco toxicant exposure, brain function and structure, and airway inflammation (fractional nitric oxide concentration in exhaled breath [FeNO]).


Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Other: Cigarettes with varying nicotine content Other: E-Cigarettes Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double blind dosing of tobacco cigarette nicotine levels.
Primary Purpose: Basic Science
Official Title: Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: RC 1 only
Research cigarettes #1
Other: Cigarettes with varying nicotine content
1) Altering the nicotine content of the tobacco research cigarettes

Experimental: RC 2 only
Research Cigarettes #2
Other: Cigarettes with varying nicotine content
1) Altering the nicotine content of the tobacco research cigarettes

Experimental: RC 2 + EC 1
Research Cigarettes #2 plus E-cigarettes #1
Other: Cigarettes with varying nicotine content
1) Altering the nicotine content of the tobacco research cigarettes

Other: E-Cigarettes
1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig conditions

Experimental: RC 2 + EC 2
Research Cigarettes #2 plus E-cigarettes #2
Other: Cigarettes with varying nicotine content
1) Altering the nicotine content of the tobacco research cigarettes

Other: E-Cigarettes
1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig conditions




Primary Outcome Measures :
  1. Cigarettes per day [ Time Frame: 16 weeks ]
    Cigarettes per day will be assessed for use of cigarettes with different nicotine content.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must be female.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • 21 to 44 years old

Exclusion Criteria:

  • Male
  • Under 21 years old
  • Over 44 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092387


Contacts
Layout table for location contacts
Contact: Catherine Markesich 8026569981 cmarkesi@uvm.edu

Sponsors and Collaborators
University of Vermont
National Institute on Drug Abuse (NIDA)
Food and Drug Administration (FDA)
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Stephen T. Higgins, Ph.D. University of Vermont

Layout table for additonal information
Responsible Party: Stephen T. Higgins, PhD, Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT04092387     History of Changes
Other Study ID Numbers: CHRMS19-0129
U54DA036114-06 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephen T. Higgins, PhD, University of Vermont:
Biomarkers of Exposure
Compensatory Smoking
Nicotine Dependence
Reduced Nicotine Cigarettes
Tobacco Withdrawal
Women
Health Disparities
Vulnerable Populations
E-Cigarettes
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action