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NCT01857531 · ClinicalTrials.gov registry record · Phase 2
Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate
A Phase 2 study of Smoking Cessation, sponsored by Jed E. Rose.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 4
- Study locations
NCT01857531: Completed Phase 2 study of Smoking Cessation, sponsored by Jed E. Rose.
NCT01857531 is a Phase 2 study of Smoking Cessation that has completed, run by Jed E. Rose. The registered enrollment target is 36 participants, below the 475-participant average among 188 other Smoking Cessation trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01857531, a Phase 2 study of Smoking Cessation, has completed, sponsored by Jed E. Rose.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this research study is to evaluate whether the investigational drug ganaxolone can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other research studies) for the treatment of seizures and migraines. This drug is considered investigational in the US.
Primary Outcome
To evaluate the effects of ganaxolone on ad lib smoking by looking at the percent change in expired air CO at the end of week two (relative to baseline).
Conditions Studied
Interventions
- DRUG Nicotine Patch
- DRUG Ganaxolone
Study Locations (4)
North Carolina
- Duke Center for Smoking Cessation - Charlotte
- Duke Center for Smoking Cessation - Durham
- Duke Center for Smoking Cessation - Raleigh
- Duke Center for Smoking Cessation - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-02 |
| Phase | Phase 2 |
What the finished NCT01857531 record still lists
NCT01857531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 475-participant average among 188 other Smoking Cessation trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Smoking Cessation appearing as the primary indexed condition, and to 2 interventions - of which Nicotine Patch is the first listed.
NCT01857531 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01857531 about?
NCT01857531 is a clinical study titled "Proof-Of-Concept Investigation With a Neurosteroid Analog (Ganaxolone) as a Smoking Cessation Candidate". The purpose of this research study is to evaluate whether the investigational drug ganaxolone can help smokers quit smoking. Ganaxolone is a drug that has been investigated (in other research studies) for the treatment of seizures and migraines. This drug is considered investigational in the US.
What is the current status of trial NCT01857531?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2013-06. Estimated completion is 2014-02.
What conditions does trial NCT01857531 study?
This clinical trial studies the following conditions: Smoking Cessation.
What interventions are being tested in trial NCT01857531?
The interventions under investigation include: Nicotine Patch (DRUG), Ganaxolone (DRUG).
Who is sponsoring clinical trial NCT01857531?
This trial is sponsored by Jed E. Rose, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01857531 being conducted?
This trial has 4 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoking Cessation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01857531's enrollment target sits among peer trials
36 164th of 188 higher than 25 of 188 other Smoking Cessation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking Cessation 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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