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Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders

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ClinicalTrials.gov Identifier: NCT04090879
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
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 US 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 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, 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 with current ADs will be recruited at Brown 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

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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
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


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 cigarette

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

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 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
Other: Cigarettes with varying nicotine content
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

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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

Minimum Age: 18 Years

Maximum Age: 70 Years

Participants must have current diagnosis of an Affective Disorder.


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


Contacts
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Contact: Catherine Markesich 8029991981 cmarkesi@uvm.edu

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     History of Changes
Other Study ID Numbers: CHRMS19-0129
U54DA036114-06 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
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