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

November 22, 2010
October 19, 2016
August 2010
July 2013   (Final data collection date for primary outcome measure)
  • Mean Number of Days Per Week of Cocaine Use [ Time Frame: 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.
  • 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 ]
    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
  • Proportion of Positive Urine Samples Per Week [ Time Frame: 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.
  • Proportion of Positive Urine Samples Per Week [ Time Frame: 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.
Decreased use of cocaine [ Time Frame: 12 weeks postpartum ]
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.
Complete list of historical versions of study NCT01249274 on ClinicalTrials.gov Archive Site
  • Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group [ Time Frame: 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.
  • Cocaine Craving (Measured Weekly Using CCQ-Brief) [ Time Frame: 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.
  • Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS)) [ Time Frame: 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.
  • Salivary Progesterone Concentrations [ Time Frame: week 2, week 6, week 10, week 12 ]
    A comparison of salivary progesterone concentrations across all samples for all timepoints
Adverse events of progesterone among a group of postpartum women at risk for cocaine use. [ Time Frame: 12 weeks postpartum ]
To obtain information about the safety and tolerability of progesterone treatment in the postpartum period, women will be queried at every visit about onset of adverse events, their seriousness, and their relatedness to study medication. Such data will be monitored in SAETRS.
Not Provided
Not Provided
 
Progesterone for Postpartum Cocaine Relapse
Progesterone for Postpartum Cocaine Relapse
The investigators propose a placebo-controlled, randomized clinical trial that would enroll 50 postpartum women with a history of cocaine abuse or dependence to assess whether progesterone (100mgs twice daily) decreases postpartum cocaine use.

Specific Aim 1: To evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo.

Hypothesis 1: Compared to women who are randomized to placebo, those assigned to progesterone will use less cocaine as measured by urine toxicology results and self-reported days of use.

Specific aim 2: To obtain information about the safety and tolerability of progesterone treatment in the postpartum period.

Hypothesis 2: Side effects for progesterone will be similar to those of placebo.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Cocaine Abuse
  • Cocaine Dependence
  • Drug: Progesterone
    100mgs progesterone twice daily
    Other Name: prometrium
  • Other: Placebo
    Matched placebo pills to be taken twice daily
  • Placebo Comparator: Placebo
    Matched placebo pills to be taken twice daily
    Intervention: Other: Placebo
  • Experimental: Progesterone
    100 mgs progesterone twice daily
    Intervention: Drug: Progesterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2013
July 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gravidas (women who delivered a baby in the past 12 weeks) who are 18 or older are eligible to participate.
  • Women must meet diagnostic criteria for abuse or dependence of cocaine in the six-months prior to conception or during pregnancy.
  • Women who abuse other illicit substances or alcohol would also be eligible as long as cocaine was their primary drug of abuse. If women are also opiate dependent, they must be undergoing treatment with methadone or buprenorphine. While we propose to target cocaine we will also monitor the ability of women with polysubstance use to maintain abstinence from substances other than cocaine.

Exclusion Criteria:

Women will be ineligible for the trial if they:

  1. have a history of major medical illnesses including liver diseases, suspected or known malignancy, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke or other medical conditions that the physician investigator deems as contraindicated for participation in the study;
  2. have a known allergy to progesterone or peanuts (vehicle for micronized progesterone);
  3. speak a language other than English;
  4. are planning on moving out of the area in the first six months after delivery;
  5. are unable to understand the study or are unable to provide informed consent;
  6. are currently undergoing treatment with another pharmacological agent for substance abuse treatment (with the exception of methadone or buprenorphine as above);
  7. have pending incarceration;
  8. are currently incarcerated;
  9. are using another progestin;
  10. are unwilling to accept randomization;
  11. are unwilling to use a barrier method of birth control for the duration of the study to ensure that they will not become pregnant.
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01249274
1005006793, R21DA029914
Yes
Not Provided
Yes
Data request should be made to the PI
Kimberly Yonkers, Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Kimberly A Yonkers, MD Yale School of Medicine
Principal Investigator: Mehmet Sofuoglu, MD, PhD Yale School of Medicine
Yale University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP