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Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

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: NCT04090879
Recruitment Status : Suspended (COVID19 pandemic)
First Posted : September 16, 2019
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
University of Vermont
Information provided by (Responsible Party):
Jennifer Tidey, Brown University

Tracking Information
First Submitted Date  ICMJE September 13, 2019
First Posted Date  ICMJE September 16, 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: September 13, 2019)
Cigarettes Per Day [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
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: Affective Disorders
Official Title  ICMJE Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders
Brief Summary

While the prevalence of smoking in the United States general population has declined over the past 50 years, there has been little to no decline among people with mental health conditions. Affective Disorders (ADs) are the most common mental health conditions in the US, and over 40% of people with ADs are current smokers. A national policy of reducing the nicotine content of cigarettes has the potential to reduce tobacco use, dependence, and related adverse health outcomes. Controlled trials in psychiatrically-stable smokers have shown that reducing the nicotine content in cigarettes can reduce cigarettes per day (CPD), dependence and tobacco toxicant exposure, with few adverse consequences.

The goal of the proposed trial is to experimentally model whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) moderates the effect of altering the nicotine in cigarettes in smokers with ADs. 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 with current ADs will be recruited at Brown University and the University of Vermont.

Investigators will study two research cigarettes referred to here as Research Cigarette 1 (RC1) and Research Cigarette 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: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)
    1) Altering the nicotine content of the tobacco research cigarette
  • Other: E-Cigarettes
    1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition
Study Arms  ICMJE
  • Experimental: RC 1 only
    Research Cigarettes #1
    Intervention: Other: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)
  • Experimental: RC 2 only
    Research Cigarettes #2
    Intervention: Other: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)
  • Experimental: RC 2 + EC 1
    Research Cigarettes #2 plus E-cigarettes #1 (participants receive tobacco flavor only)
    Interventions:
    • Other: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)
    • Other: E-Cigarettes
  • Experimental: RC 2 + EC 2
    Research Cigarettes #2 plus E-cigarettes #2 (participants can choose among varying flavors)
    Interventions:
    • Other: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)
    • 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)
232
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

  • Between 21 years and 70 years old
  • Must have current diagnosis of an Affective Disorder.

Exclusion Criteria

  • Being without an Affective Disorder
  • Younger than 21 years old
  • Older than 70 years old
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older 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 NCT04090879
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 Jennifer Tidey, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE
  • Food and Drug Administration (FDA)
  • National Institute on Drug Abuse (NIDA)
  • University of Vermont
Investigators  ICMJE
Principal Investigator: Jennifer W Tidey, Ph.D. Brown University
PRS Account Brown University
Verification Date June 2020

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