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NCT01928758 · ClinicalTrials.gov registry record · NA
Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders
A NA study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 245
- Enrollment target
NCT01928758: Completed NA study, sponsored by Milton S. Hershey Medical Center.
NCT01928758 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 245 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928758, a NA study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 245 participants
- Enrollment target
Study Summary
The overall aim of this project is to evaluate the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxin exposure and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders. Smokers with mood and/or anxiety disorder will smoke research cigarettes that will contain either a) nicotine content similar to their preferred usual brand of cigarettes, or b) nicotine content per cigarette that is progressively reduced from approximately 11.6 mg to 0.2 mg per cigarette over 18 weeks. It is our hypothesis that nicotine intake will decline as a function of cigarette nicotine content in the Reduced Nicotine Content group without significant increases in tobacco smoke exposure, severity of nicotine withdrawal symptoms, mood and anxiety symptomatology or protocol non-adherence over time in the Reduced Nicotine Content group as compared with the control group.
Primary Outcome
Plasma cotinine is a measure of daily nicotine exposure. Samples were measured in ng/mL.
Interventions
- DRUG Reduced Nicotine Content Cigarettes
- DRUG Usual Nicotine Content Cigarettes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2015-09 |
| Est. Completion | 2018-03-23 |
| Phase | NA |
What the finished NCT01928758 record still lists
NCT01928758 is an interventional study that assigns participants to a tested intervention. The registered 245 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Reduced Nicotine Content Cigarettes is the first listed.
NCT01928758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01928758 about?
NCT01928758 is a clinical study titled "Reduced Nicotine Cigarettes in Smokers With Mood and Anxiety Disorders". The overall aim of this project is to evaluate the effect of progressive nicotine reduction in cigarettes on smoking behavior, toxin exposure and psychiatric symptoms in smokers with comorbid mood and/or anxiety disorders. Smokers with mood and/or anxiety disorder will smoke research cigarettes tha...
What is the current status of trial NCT01928758?
This trial is currently completed. It is a NA study. The enrollment target is 245 participants. The study started on 2015-09. Estimated completion is 2018-03-23.
What interventions are being tested in trial NCT01928758?
The interventions under investigation include: Reduced Nicotine Content Cigarettes (DRUG), Usual Nicotine Content Cigarettes (DRUG).
Who is sponsoring clinical trial NCT01928758?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01928758's enrollment target sits among peer trials
245 436th of 2000 higher than 1,563 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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