Progesterone for Postpartum Cocaine Relapse

Cocaine Dependence Clinical Trial

Official title: Progesterone for Postpartum Cocaine Relapse

Status Completed

Clinical Trial 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 Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

• Cocaine Abuse
• Cocaine Dependence
• Cocaine-Related Disorders
• Postpartum Period

• NCT number: NCT01249274
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Completion date: July 2013