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NCT02685072 · ClinicalTrials.gov registry record · Phase 4
Progesterone Augmentation of Nicotine Replacement Therapy Study
A Phase 4 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
NCT02685072 is a Phase 4 study that has completed, run by Yale University. The registered enrollment target is 64 participants.
The verdict
NCT02685072, a Phase 4 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
Study Summary
This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of 50 women who smoke and have regular menstrual cycles will be randomized to either progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks. TNP will be tapered after 4-6 weeks. Progesterone or matching placebo will be discontinued at the end of Week 8. All participants will also be provided behavioral treatment for smoking cessation. Participants will be inducted onto progesterone (or placebo) + TNP over a one-week period (Week 1) during the mid luteal phase, within a week before menses and the target quit date will be set for the 5 (+/-2) days after onset of menses. Participants will have post-trial follow-up visits at 1 and 3 months.The main study outcomes will be self- report of smoking abstinence, biochemically verified smoking abstinence, measures of cigarette craving and nicotine withdrawal, and measures of response inhibition.
Interventions
- DRUG Placebo
- DRUG Progesterone (200 mgs BID)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2016-04-07 |
| Est. Completion | 2018-03-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02685072
The ClinicalTrials.gov registry entry for NCT02685072 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02685072 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02685072 about?
NCT02685072 is a clinical study titled "Progesterone Augmentation of Nicotine Replacement Therapy Study". This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of 50 women who smoke and have regular menstrual cycles will be randomized to either progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks. TNP will be tapered after 4-6 we...
What is the current status of trial NCT02685072?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2016-04-07. Estimated completion is 2018-03-12.
What interventions are being tested in trial NCT02685072?
The interventions under investigation include: Placebo (DRUG), Progesterone (200 mgs BID) (DRUG).
Who is sponsoring clinical trial NCT02685072?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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