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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
  Purpose

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.


Condition Intervention
Cocaine Abuse
Cocaine Dependence
Postpartum Period
Drug: Progesterone
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Progesterone for Postpartum Cocaine Relapse

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: August 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matched placebo pills to be taken twice daily
Other: Placebo
Matched placebo pills to be taken twice daily
Experimental: Progesterone
100 mgs progesterone twice daily
Drug: Progesterone
100mgs progesterone twice daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249274

Locations
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Kimberly A Yonkers, MD Yale School of Medicine
Principal Investigator: Mehmet Sofuoglu, MD, PhD Yale School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Kimberly Yonkers, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01249274     History of Changes
Other Study ID Numbers: 1005006793, R21DA029914
Study First Received: November 22, 2010
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
cocaine abuse
cocaine dependence
postpartum period

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Cocaine
Progesterone
Anesthetics
Anesthetics, Local
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Progestins
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 24, 2014