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NCT04090879 · ClinicalTrials.gov registry record · Phase 2
Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders
A Phase 2 study, sponsored by Brown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 326
- Enrollment target
NCT04090879 is a Phase 2 study that has completed, run by Brown University. The registered enrollment target is 326 participants.
The verdict
NCT04090879, a Phase 2 study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 326 participants
- Enrollment target
Study 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. Part
Interventions
- OTHER E-Cigarettes
- OTHER Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2020-10-18 |
| Est. Completion | 2023-11-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04090879
The ClinicalTrials.gov registry entry for NCT04090879 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 326 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which E-Cigarettes is the first listed.
NCT04090879 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04090879 about?
NCT04090879 is a clinical study titled "Low Nicotine Content Cigarettes in Vulnerable Populations: Affective Disorders". 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 A...
What is the current status of trial NCT04090879?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 326 participants. The study started on 2020-10-18. Estimated completion is 2023-11-27.
What interventions are being tested in trial NCT04090879?
The interventions under investigation include: E-Cigarettes (OTHER), Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g) (OTHER).
Who is sponsoring clinical trial NCT04090879?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
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