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NCT01954966 · ClinicalTrials.gov registry record · Phase 4
Progesterone and Brain Imaging Study
A Phase 4 study of Nicotine Dependence and Nicotine Withdrawal, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
- 1
- Study location
NCT01954966: Completed Phase 4 study of Nicotine Dependence and Nicotine Withdrawal, sponsored by University of Pennsylvania.
NCT01954966 is a Phase 4 study of Nicotine Dependence and Nicotine Withdrawal that has completed, run by University of Pennsylvania. The registered enrollment target is 81 participants, below the 186-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01954966, a Phase 4 study of Nicotine Dependence and Nicotine Withdrawal, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
- 1
- Study location
Study Summary
Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving progesterone or a matched placebo.
Primary Outcome
GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex \[DACC\]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between parad
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Progesterone
Study Locations (1)
Pennsylvania
- Penn Center for Women's Behavioral Wellness - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2010-11 |
| Est. Completion | 2021-12 |
| Phase | Phase 4 |
What the finished NCT01954966 record still lists
NCT01954966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 186-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (56% lower).
The record links to 2 conditions, with Nicotine Dependence appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01954966 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01954966 about?
NCT01954966 is a clinical study titled "Progesterone and Brain Imaging Study". Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving progesterone or a matched placebo.
What is the current status of trial NCT01954966?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2010-11. Estimated completion is 2021-12.
What conditions does trial NCT01954966 study?
This clinical trial studies the following conditions: Nicotine Dependence, Nicotine Withdrawal.
What interventions are being tested in trial NCT01954966?
The interventions under investigation include: Placebo (DRUG), Progesterone (DRUG).
Who is sponsoring clinical trial NCT01954966?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01954966 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Nicotine Dependence
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 NCT01954966's enrollment target sits among peer trials
81 41st of 67 higher than 27 of 67 other Nicotine Dependence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nicotine Dependence 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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