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Progesterone for Postpartum Cocaine Relapse

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier:
NCT01249274
First received: November 22, 2010
Last updated: October 19, 2016
Last verified: October 2016
Results First Received: January 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Cocaine Abuse
Cocaine Dependence
Interventions: Drug: Progesterone
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
On-site clinic screening assessments were performed in three obstetrics clinic associated with the Yale New Haven Hospital System in New Haven, CT, USA. Study referrals were accepted from the New Haven area. Both post-partum and pregnant women were screened. Screenings began in October of 2010 and finished in February of 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
75 women were scheduled for intake, but 24 did not complete intake interview and 1 was ineligible for randomisation because of a medical issue. The first 50 eligible women were randomly assigned.

Reporting Groups
  Description
Placebo

Matched placebo pills to be taken twice daily

Placebo: Matched placebo pills to be taken twice daily

Progesterone

100 mgs progesterone twice daily

Progesterone: 100mgs progesterone twice daily


Participant Flow:   Overall Study
    Placebo   Progesterone
STARTED   25 [1]   25 [1] 
Completed Treatment   21   19 
Completed Treatment & Post Trial Visit   20   17 
Completed Post Trial Visit But Not tx   1   2 
COMPLETED   21   19 
NOT COMPLETED   4   6 
Lost to Follow-up                3                4 
Received inpatient substance treatment                1                2 
[1] all 25 were included in intention-to-treat and safety analyses



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All 25 in each study group were included in intention-to-treat and safety analyses.

Reporting Groups
  Description
Placebo

Matched placebo pills to be taken twice daily

Placebo: Matched placebo pills to be taken twice daily

Progesterone

100 mgs progesterone twice daily

Progesterone: 100mgs progesterone twice daily

Total Total of all reporting groups

Baseline Measures
   Placebo   Progesterone   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.6  (6.3)   30.5  (4.5)   31.6  (2.4) 
Gender 
[Units: Participants]
     
Female   25   25   50 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   12   16   28 
Black   12   4   16 
Hispanic or other   1   5   6 
Region of Enrollment 
[Units: Participants]
     
United States   25   25   50 
Education 
[Units: Participants]
     
Less than high shool   9   4   13 
High school   8   9   17 
Post-high school   8   12   20 
Marital status 
[Units: Participants]
     
Married or cohabitating   5   7   12 
Divorced   3   1   4 
Separated   2   2   4 
Dating   6   1   7 
Single   9   14   23 
Employment status 
[Units: Participants]
     
In paid employment   7   3   10 
Not in paid employment   17   20   37 
Unknown   1   2   3 
Weeks post partum 
[Units: Weeks]
Mean (Standard Deviation)
 3.4  (5.1)   3.6  (4.6)   3.5  (2.3) 
Lifetime cocaine use (years) 
[Units: Years]
Mean (Standard Deviation)
 8.5  (7.2)   6.2  (4.2)   7.4  (2.8) 
Age at first cocaine use (years) 
[Units: Years]
Mean (Standard Deviation)
 20.6  (6.3)   19.2  (4.0)   19.9  (2.2) 
Parity 
[Units: Births]
Mean (Standard Deviation)
 2.6  (1.6)   2.1  (1.4)   2.4  (0.2) 
EPDS score at intake [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 11.2  (6.7)   11.2  (7.2)   11.2  (3.9) 
[1] The Edinburgh Postnatal Depression scale measures depression and has 10 items with range of 0-30. Higher scores indicate more severe depression.
Baseline cocaine use (days per week) [1] 
[Units: Days]
Mean (Standard Deviation)
 0.41  (.91)   1.15  (3.84)   1.1  (1.0) 
[1] Baseline cocaine use (days of use per week, averaged across 4 weeks prior to baseline, maximum value=7 days)
Not using cocaine at intake 
[Units: Participants]
     
Not using cocaine at intake   22   19   41 
Using cocaine at intake   3   6   9 
Methadone maintained 
[Units: Participants]
     
Using methadone   8   14   22 
not using methadone   17   11   28 
Any lifetime major depressive episode 
[Units: Participants]
     
History of MDD   4   3   7 
No history of MDD   21   22   43 
Social phobia 
[Units: Participants]
     
History of social phobia   5   1   6 
No history of social phobia   20   24   44 
Obsessive compulsive disorder 
[Units: Participants]
     
yes   4   0   4 
no   21   25   46 
Generalized anxiety disorder 
[Units: Participants]
     
yes   6   8   14 
no   19   17   36 
Post-traumatic stress disorder 
[Units: Participants]
     
yes   5   6   11 
no   20   19   39 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Number of Days Per Week of Cocaine Use   [ Time Frame: Weekly measurements, Baseline to 12 weeks ]

2.  Primary:   Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up   [ Time Frame: baseline, end of trial (week 12), 3-month post-trial follow-up ]

3.  Primary:   Proportion of Positive Urine Samples Per Week   [ Time Frame: weekly measurements, baseline to 12 weeks ]

4.  Primary:   Proportion of Positive Urine Samples Per Week   [ Time Frame: baseline, end of trial (week 12) and 3-month post-trial follow-up ]

5.  Secondary:   Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group   [ Time Frame: 12 weeks postpartum ]

6.  Secondary:   Cocaine Craving (Measured Weekly Using CCQ-Brief)   [ Time Frame: baseline to 12 weeks ]

7.  Secondary:   Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))   [ Time Frame: baseline to 12 weeks ]

8.  Secondary:   Salivary Progesterone Concentrations   [ Time Frame: week 2, week 6, week 10, week 12 ]

9.  Post-Hoc:   Relapse to Cocaine Use During Treatment Period   [ Time Frame: baseline to 12 weeks ]

10.  Post-Hoc:   Relapse to Cocaine Use During Treatment Period or 3 Months Post Treatment   [ Time Frame: baseline to 3 months post 12-week trial period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kimberly A. Yonkers, M.D.
Organization: Yale University
phone: 203-764-6621
e-mail: kimberly.yonkers@yale.edu



Responsible Party: Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier: NCT01249274     History of Changes
Other Study ID Numbers: 1005006793
R21DA029914 ( US NIH Grant/Contract Award Number )
Study First Received: November 22, 2010
Results First Received: January 5, 2016
Last Updated: October 19, 2016