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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

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]).


Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Other: Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g) Other: E-Cigarettes Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 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: Affective Disorders
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RC 1 only
Research Cigarettes #1
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

Experimental: RC 2 only
Research Cigarettes #2
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

Experimental: RC 2 + EC 1
Research Cigarettes #2 plus E-cigarettes #1 (participants receive tobacco flavor only)
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

Experimental: RC 2 + EC 2
Research Cigarettes #2 plus E-cigarettes #2 (participants can choose among varying flavors)
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




Primary Outcome Measures :
  1. Cigarettes Per Day [ Time Frame: 16 weeks ]


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.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04090879


Locations
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United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Brown University
Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
University of Vermont
Investigators
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Principal Investigator: Jennifer W Tidey, Ph.D. Brown University
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Responsible Party: Jennifer Tidey, Professor, Brown University
ClinicalTrials.gov Identifier: NCT04090879    
Other Study ID Numbers: CHRMS19-0129
U54DA036114-06 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Tidey, Brown University:
Biomarkers of Exposure
Compensatory Smoking
Nicotine Dependence
Reduced Nicotine Cigarettes
Affective Disorders
Tobacco Withdrawal
Vulnerable Populations
E-Cigarettes
Additional relevant MeSH terms:
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Disease
Tobacco Use Disorder
Mood Disorders
Pathologic Processes
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