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NCT02870218 · ClinicalTrials.gov registry record · Phase 2
Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use
A Phase 2 study, sponsored by Rose Research Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT02870218 is a Phase 2 study that has completed, run by Rose Research Center. The registered enrollment target is 150 participants.
The verdict
NCT02870218, a Phase 2 study, has completed, sponsored by Rose Research Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
Three hundred-twenty (320) adult smokers of menthol or non-menthol combustible cigarettes will be recruited and randomly assigned to one of five groups (n=64/group), who will be asked to switch for 12 weeks to ad libitum use of combustible cigarettes (matched to subjects' menthol preference) containing either 0.4, 1.4, 2.5, 5.6 or 16.9 mg nicotine (standardized nicotine yields ranging from 0.02-0.80 mg/cigarette), respectively. Each group will include 32 heavy (≥ 20 cigarettes/day), and 32 light smokers (≤10 cigarettes/day), who are hypothesized to be more sensitive to nicotine's reinforcing effects. Participants will also have free access to nicotine-containing e-cigarettes (JUUL) throughout the 12-week period. Abuse liability of combustible cigarettes will be assessed by behavioral (cigarettes/day, time to first cigarettes), self-report (rewarding effects, withdrawal symptoms) and biochemical indices (expired air carbon monoxide, cotinine blood sampling). In laboratory sessions, we will measure nicotine thresholds for detecting and recognizing the addictive, rewarding effects of smoking. This study is designed to help the FDA identify a target nicotine threshold that will not attract young people to smoking or induce relapse in former smokers. Additionally, we will determine the level of cigarette nicotine reduction that will be tolerated without inducing dissatisfaction in smokers, information that is relevant to the FDA for designing a stepwise nicotine reduction policy that can be implemented without widespread objections. The knowledge gained from this project will greatly increase our knowledge of nicotine addiction and will help frame an FDA policy relating to the regulation of the nicotine content of tobacco. Ultimately, a well-designed nicotine reduction policy has the potential to greatly reduce the enormous toll of death and disease caused by cigarette smoking.
Interventions
- DRUG Smoking research cigarettes with e-cigarette
- DRUG Nicotine discrimination thresholds
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2021-07-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02870218
The ClinicalTrials.gov registry entry for NCT02870218 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rose Research Center, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Smoking research cigarettes with e-cigarette is the first listed.
NCT02870218 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02870218 about?
NCT02870218 is a clinical study titled "Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use". Three hundred-twenty (320) adult smokers of menthol or non-menthol combustible cigarettes will be recruited and randomly assigned to one of five groups (n=64/group), who will be asked to switch for 12 weeks to ad libitum use of combustible cigarettes (matched to subjects' menthol preference) contain...
What is the current status of trial NCT02870218?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2019-05-01. Estimated completion is 2021-07-28.
What interventions are being tested in trial NCT02870218?
The interventions under investigation include: Smoking research cigarettes with e-cigarette (DRUG), Nicotine discrimination thresholds (DRUG).
Who is sponsoring clinical trial NCT02870218?
This trial is sponsored by Rose Research Center, which has 11 total clinical trials registered on ClinicalTrials.gov.
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