Progesterone for Postpartum Cocaine Relapse
This study is ongoing, but not recruiting participants.
Sponsor:
Yale University
Collaborator:
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier:
NCT01249274
First received: November 22, 2010
Last updated: February 27, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | May 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:
- 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.
Contacts and Locations
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: | February 27, 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 Substance-Related Disorders Mental Disorders Cocaine Progesterone Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013