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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04092387
Recruitment Status : Suspended (COVID19 pandemic)
First Posted : September 17, 2019
Last Update Posted : June 11, 2020
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

Tracking Information
First Submitted Date  ICMJE September 13, 2019
First Posted Date  ICMJE September 17, 2019
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE September 18, 2019
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
Number of Cigarettes Smoked Per Day [ Time Frame: 16 weeks ]
Cigarettes per day will be assessed for use of cigarettes with different nicotine content.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
Cigarettes per day [ Time Frame: 16 weeks ]
Cigarettes per day will be assessed for use of cigarettes with different nicotine content.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age
Official Title  ICMJE Low Nicotine Content Cigarettes in Vulnerable Populations: Women of Reproductive Age
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, investigators 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.

Investigators will study two research cigarettes referred to here as Research Cigarettes 1 (RC1) and Research Cigarettes 2 (RC2). One of these cigarettes will be a normal nicotine content cigarette and the other will be a reduced nicotine content cigarette. Investigators will study two e-cigarette conditions referred to here as E-Cigarette Condition 1 (EC1) and E-Cigarette Condition 2 (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]).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: RC 1 only
    Research cigarettes #1
    Intervention: Other: Cigarettes with varying nicotine content
  • Experimental: RC 2 only
    Research Cigarettes #2
    Intervention: Other: Cigarettes with varying nicotine content
  • Experimental: RC 2 + EC 1
    Research Cigarettes #2 plus E-cigarettes #1
    Interventions:
    • Other: Cigarettes with varying nicotine content
    • Other: E-Cigarettes
  • Experimental: RC 2 + EC 2
    Research Cigarettes #2 plus E-cigarettes #2
    Interventions:
    • Other: Cigarettes with varying nicotine content
    • Other: E-Cigarettes
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
246
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female
  • 21 to 44 years old

Exclusion Criteria:

  • Male
  • Under 21 years old
  • Over 44 years old
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Participants must be female.
Ages  ICMJE 18 Years to 44 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04092387
Other Study ID Numbers  ICMJE CHRMS19-0129
U54DA036114-06 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Stephen T. Higgins, PhD, University of Vermont
Study Sponsor  ICMJE University of Vermont
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Food and Drug Administration (FDA)
  • Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Stephen T. Higgins, Ph.D. University of Vermont
PRS Account University of Vermont
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP