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NCT02019459 · ClinicalTrials.gov registry record · Phase 2
Very Low Nicotine Cigarettes in Smokers With Schizophrenia
A Phase 2 study of Tobacco Dependence, sponsored by Brown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT02019459 is a Phase 2 study of Tobacco Dependence that has completed, run by Brown University. The registered enrollment target is 58 participants, below the 477-participant average among 28 other Tobacco Dependence trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02019459, a Phase 2 study of Tobacco Dependence, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study will examine whether reducing the nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking in smokers with serious mental illness. Smokers will be randomized to one of two experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.
Conditions Studied
Interventions
- OTHER Very low nicotine content cigarettes
- OTHER standard nicotine content cigarettes
Study Locations (1)
Rhode Island
- Brown University - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2014-11-17 |
| Est. Completion | 2017-08-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02019459
The ClinicalTrials.gov registry entry for NCT02019459 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 477-participant average among 28 other Tobacco Dependence trials with a reported enrollment target (88% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tobacco Dependence appearing as the primary indexed condition, and to 2 interventions - of which Very low nicotine content cigarettes is the first listed.
NCT02019459 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT02019459 about?
NCT02019459 is a clinical study titled "Very Low Nicotine Cigarettes in Smokers With Schizophrenia". Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study will examine whether reducing the nicotine content of cigarettes to ...
What is the current status of trial NCT02019459?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2014-11-17. Estimated completion is 2017-08-31.
What conditions does trial NCT02019459 study?
This clinical trial studies the following conditions: Tobacco Dependence.
What interventions are being tested in trial NCT02019459?
The interventions under investigation include: Very low nicotine content cigarettes (OTHER), standard nicotine content cigarettes (OTHER).
Who is sponsoring clinical trial NCT02019459?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02019459 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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