Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01972464 · ClinicalTrials.gov registry record · Phase 2
Progesterone for Smoking Relapse Prevention Following Delivery
A Phase 2 study of Tobacco Use Disorder, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 1
- Study location
NCT01972464 is a Phase 2 study of Tobacco Use Disorder that has completed, run by Yale University. The registered enrollment target is 41 participants, below the 239-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01972464, a Phase 2 study of Tobacco Use Disorder, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 1
- Study location
Study Summary
Smoking is the main preventable cause of mortality in Western countries, contributing to over 430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that women often decrease smoking in pregnancy, when progesterone levels are high. However, at least half resume pre-pregnancy smoking levels within weeks after delivery and when progesterone levels drop. Data from preclinical and clinical studies suggest that progesterone may be effective in preventing relapse to smoking in non-postpartum women. Prior work has shown that progesterone decreases both craving for cigarettes and the subjective rewarding effects of smoking among recently abstinent female smokers. These findings led us to hypothesize that progesterone may have efficacy as a relapse prevention treatment for postpartum women. We propose an 8-week, randomized pilot study to evaluate the safety and initial efficacy of progesterone. This will be a feasibility study that will compare progesterone to placebo for relapse prevention in 40 postpartum smokers. We will assess the feasibility and safety, including the potential effects on breastfeeding and infants exposed via breast milk, in addition to 7-day point prevalence of smoking abstinence after 8 weeks of treatment and at follow-up, 3-months after the end of the protocol.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Progesterone
Study Locations (1)
Connecticut
- Yale School of Medicine Dpt of Psychiatry - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01972464
The ClinicalTrials.gov registry entry for NCT01972464 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (83% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tobacco Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01972464 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT01972464 about?
NCT01972464 is a clinical study titled "Progesterone for Smoking Relapse Prevention Following Delivery". Smoking is the main preventable cause of mortality in Western countries, contributing to over 430,000 deaths a year in the U.S. alone. Clinical and epidemiological studies show that women often decrease smoking in pregnancy, when progesterone levels are high. However, at least half resume pre-pregna...
What is the current status of trial NCT01972464?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2013-11. Estimated completion is 2016-09.
What conditions does trial NCT01972464 study?
This clinical trial studies the following conditions: Tobacco Use Disorder.
What interventions are being tested in trial NCT01972464?
The interventions under investigation include: Placebo (DRUG), Progesterone (DRUG).
Who is sponsoring clinical trial NCT01972464?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01972464 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tobacco Use Disorder
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.
-
Nicotine Regulation for Dual Users of E-cigarettes and Cigarettes
RECRUITING · Phase 2
-
Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity
RECRUITING · Phase 2
-
Cannabidiol for Reducing Cigarette Use
RECRUITING · Phase 2
-
An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction
RECRUITING · Phase 2
-
Neuroimaging Correlates and Feasibility of Transcranial Magnetic Stimulation (TMS) to Improve Smoking Cessation Outcomes in Veterans With Comorbid PTSD
RECRUITING · Phase 2
-
Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.