Trial · NCT01249274

Progesterone for Postpartum Cocaine Relapse

NCT01249274, Not applicable, Completed, Yale University; results first posted 2016-12-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Progesterone for Postpartum Cocaine Relapse. Trials, record NCT01249274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01249274

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Progesterone for Postpartum Cocaine Relapse
NCT number: NCT01249274
Status: Completed
Phases: Not applicable
Enrollment: 50 participants, actual
Lead sponsor: Yale University
Conditions: Cocaine Abuse, Cocaine Dependence
Interventions: Progesterone, Placebo
First posted: 2010-11-29
Last updated: 2017-03-28
Results first posted: 2016-12-12
Limitations and caveats: Women seen only once per week leading to reliance on self-reports more than urine, results of which differed; post-partum women with cocaine use disorder have other issues affecting likelihood of cocaine use; missed visits may have biased results.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Number of Days Per Week of Cocaine Use	Weekly measurements, Baseline to 12 weeks	Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week via substance use calendar.
Primary	Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up	baseline, end of trial (week 12), 3-month post-trial follow-up	Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Measured by self-reported days of cocaine use per week during the trial period and during 3 month follow up using the substance use calendar
Primary	Proportion of Positive Urine Samples Per Week	weekly measurements, baseline to 12 weeks	Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.
Primary	Proportion of Positive Urine Samples Per Week	baseline, end of trial (week 12) and 3-month post-trial follow-up	Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.
Secondary	Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group	12 weeks postpartum	To obtain information about the safety and tolerability of progesterone treatment in the postpartum period, women were queried at every visit about onset of adverse events, their seriousness, and their relatedness to study medication. Such data was monitored in SAETRS.
Secondary	Cocaine Craving (Measured Weekly Using CCQ-Brief)	baseline to 12 weeks	CCQ-Brief is a ten-item questionnaire developed from the 45-item CCQ. Each item is scored on a visual analogue scale ranging from 1-7, and items are averaged to yield a score from 1 to 7. Higher scores indicate stronger cocaine cravings.
Secondary	Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))	baseline to 12 weeks	EPDS scores were measured to detect depression as a possible adverse event and compare scores between the two groups. The scale consists of 10 items. Each item is scored from 0 to 3, and the 10 items are summed to calculate a total score with a possible range of 0 to 30 and higher scores indicating more severe depression.
Secondary	Salivary Progesterone Concentrations	week 2, week 6, week 10, week 12	A comparison of salivary progesterone concentrations across all samples for all timepoints

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Number of Days Per Week of Cocaine Use	Weekly measurements, Baseline to 12 weeks	intent-to-treat	number of days per week of cocaine use	MEAN
PRIMARY	Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up	baseline, end of trial (week 12), 3-month post-trial follow-up	intent-to-treat	days of cocaine use between visits	MEAN
PRIMARY	Proportion of Positive Urine Samples Per Week	weekly measurements, baseline to 12 weeks	intent-to-treat	proportion of positive urines per week	MEAN
PRIMARY	Proportion of Positive Urine Samples Per Week	baseline, end of trial (week 12) and 3-month post-trial follow-up	intent-to-treat	proportion of positive urines per week	MEAN
SECONDARY	Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group	12 weeks postpartum	intent-to-treat	adverse events	NUMBER
SECONDARY	Cocaine Craving (Measured Weekly Using CCQ-Brief)	baseline to 12 weeks	intent-to-treat	units on a scale	MEAN
SECONDARY	Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))	baseline to 12 weeks	intent-to-treat	units on a scale	MEAN
SECONDARY	Salivary Progesterone Concentrations	week 2, week 6, week 10, week 12	intent-to-treat	pg/ml of salivary progesterone	MEAN
POST_HOC	Relapse to Cocaine Use During Treatment Period	baseline to 12 weeks	intent-to-treat	participants who relapsed to cocaine use	NUMBER
POST_HOC	Relapse to Cocaine Use During Treatment Period or 3 Months Post Treatment	baseline to 3 months post 12-week trial period	intent-to-treat	participants who relapsed to cocaine use	NUMBER

Source ClinicalTrials.gov

Results by group132

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Number of Days Per Week of Cocaine Use	Placebo	Baseline	0.41	Standard Deviation 0.91	number of days per week of cocaine use
Mean Number of Days Per Week of Cocaine Use	Progesterone	Baseline	1.15	Standard Deviation 3.84	number of days per week of cocaine use
Mean Number of Days Per Week of Cocaine Use	Placebo	Week 1	0.43	Standard Deviation 0.88	number of days per week of cocaine use
Mean Number of Days Per Week of Cocaine Use	Progesterone	Week 1	1.01	Standard Deviation 3.15	number of days per week of cocaine use
Mean Number of Days Per Week of Cocaine Use	Placebo	Week 2	0.45	Standard Deviation 0.89	number of days per week of cocaine use
Mean Number of Days Per Week of Cocaine Use	Progesterone	Week 2	0.89	Standard Deviation 2.51	number of days per week of cocaine use
Mean Number of Days Per Week of Cocaine Use	Placebo	Week 3	0.47	Standard Deviation 0.91	number of days per week of cocaine use
Mean Number of Days Per Week of Cocaine Use	Progesterone	Week 3	0.78	Standard Deviation 2.16	number of days per week of cocaine use
Mean Number of Days Per Week of Cocaine Use	Placebo	Week 4	0.49	Standard Deviation 0.94	number of days per week of cocaine use
Mean Number of Days Per Week of Cocaine Use	Progesterone	Week 4	0.68	Standard Deviation 1.87	number of days per week of cocaine use

1 to 10 of 132Source ClinicalTrials.gov

See all 132 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	25
Overall Study	STARTED	Progesterone	25
Overall Study	Completed Treatment	Placebo	21
Overall Study	Completed Treatment	Progesterone	19
Overall Study	Completed Treatment & Post Trial Visit	Placebo	20
Overall Study	Completed Treatment & Post Trial Visit	Progesterone	17
Overall Study	Completed Post Trial Visit But Not tx	Placebo	1
Overall Study	Completed Post Trial Visit But Not tx	Progesterone	2
Overall Study	COMPLETED	Placebo	21
Overall Study	COMPLETED	Progesterone	19

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	General disorders	Placebo	3	25	3
other	Headache	General disorders	Progesterone	6	25	6
other	Sedation	General disorders	Placebo	4	25	4
other	Sedation	General disorders	Progesterone	4	25	4
other	Dizziness	General disorders	Placebo	0	25	0
other	Dizziness	General disorders	Progesterone	3	25	3
other	Dry mouth	General disorders	Placebo	3	25	3
other	Dry mouth	General disorders	Progesterone	0	25	0
other	Nausea	General disorders	Placebo	1	25	1
other	Nausea	General disorders	Progesterone	2	25	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Progesterone
Total, other adverse events	Placebo	11	25
Total, other adverse events	Progesterone	15	25
Total, serious adverse events	Placebo	0	25
Total, serious adverse events	Progesterone	0	25

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21DA029914	Progesterone for Postpartum Cocaine Relapse	YONKERS, KIMBERLY A; SOFUOGLU, MEHMET	YALE UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2010 to 2011

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Progesterone vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01249274

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API reference For AI assistants