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Progesterone for Postpartum Cocaine Relapse

Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cocaine Abuse; Cocaine Dependence; Postpartum Period

Intervention: Progesterone (Drug); Placebo (Other)

Phase: N/A

Status: Completed

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Kimberly A Yonkers, MD, Principal Investigator, Affiliation: Yale School of Medicine
Mehmet Sofuoglu, MD, PhD, Principal Investigator, Affiliation: Yale School of Medicine

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.

Clinical Details

Official title: Progesterone for Postpartum Cocaine Relapse

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Decreased use of cocaine

Secondary outcome: Adverse events of progesterone among a group of postpartum women at risk for 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.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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.

Locations and Contacts

Yale School of Medicine, New Haven, Connecticut 06510, United States
Additional Information

Research site webpage

Starting date: August 2010
Last updated: August 26, 2013

Page last updated: August 23, 2015

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