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Progesterone for Postpartum Cocaine Relapse

Primary Purpose

Cocaine Abuse, Cocaine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progesterone
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Abuse focused on measuring cocaine abuse, cocaine dependence, postpartum period

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Progesterone

Arm Description

Matched placebo pills to be taken twice daily

100 mgs progesterone twice daily

Outcomes

Primary Outcome Measures

Mean Number of Days Per Week of Cocaine Use
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
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
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
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 Outcome Measures

Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group
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)
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))
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
A comparison of salivary progesterone concentrations across all samples for all timepoints

Full Information

First Posted
November 22, 2010
Last Updated
February 24, 2017
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01249274
Brief Title
Progesterone for Postpartum Cocaine Relapse
Official Title
Progesterone for Postpartum Cocaine Relapse
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (Actual)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Abuse, Cocaine Dependence
Keywords
cocaine abuse, cocaine dependence, postpartum period

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo pills to be taken twice daily
Arm Title
Progesterone
Arm Type
Experimental
Arm Description
100 mgs progesterone twice daily
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
prometrium
Intervention Description
100mgs progesterone twice daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matched placebo pills to be taken twice daily
Primary Outcome Measure Information:
Title
Mean Number of Days Per Week of Cocaine Use
Description
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.
Time Frame
Weekly measurements, Baseline to 12 weeks
Title
Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up
Description
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
Time Frame
baseline, end of trial (week 12), 3-month post-trial follow-up
Title
Proportion of Positive Urine Samples Per Week
Description
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.
Time Frame
weekly measurements, baseline to 12 weeks
Title
Proportion of Positive Urine Samples Per Week
Description
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.
Time Frame
baseline, end of trial (week 12) and 3-month post-trial follow-up
Secondary Outcome Measure Information:
Title
Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group
Description
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.
Time Frame
12 weeks postpartum
Title
Cocaine Craving (Measured Weekly Using CCQ-Brief)
Description
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.
Time Frame
baseline to 12 weeks
Title
Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
Description
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.
Time Frame
baseline to 12 weeks
Title
Salivary Progesterone Concentrations
Description
A comparison of salivary progesterone concentrations across all samples for all timepoints
Time Frame
week 2, week 6, week 10, week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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; have a known allergy to progesterone or peanuts (vehicle for micronized progesterone); speak a language other than English; are planning on moving out of the area in the first six months after delivery; are unable to understand the study or are unable to provide informed consent; are currently undergoing treatment with another pharmacological agent for substance abuse treatment (with the exception of methadone or buprenorphine as above); have pending incarceration; are currently incarcerated; are using another progestin; are unwilling to accept randomization; are unwilling to use a barrier method of birth control for the duration of the study to ensure that they will not become pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A Yonkers, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehmet Sofuoglu, MD, PhD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data request should be made to the PI

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Progesterone for Postpartum Cocaine Relapse

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