Progesterone for Postpartum Cocaine Relapse

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier:
NCT01249274
First received: November 22, 2010
Last updated: August 26, 2013
Last verified: August 2013

November 22, 2010
August 26, 2013
August 2010
July 2013   (final data collection date for primary outcome measure)
Decreased use of cocaine [ Time Frame: 12 weeks postpartum ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01249274 on ClinicalTrials.gov Archive Site
Adverse events of progesterone among a group of postpartum women at risk for cocaine use. [ Time Frame: 12 weeks postpartum ] [ Designated as safety issue: Yes ]
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.
Same as current
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Cocaine Abuse
  • Cocaine Dependence
  • Postpartum Period
  • Drug: Progesterone
    100mgs progesterone twice daily
  • 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.
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01249274
1005006793, R21DA029914
Yes
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
August 2013

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