NCT01249274

Progesterone for Postpartum Cocaine Relapse

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cocaine Abuse
• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Progesterone	100mgs progesterone twice daily
OTHER	Placebo	Matched placebo pills to be taken twice daily

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2010-11-29
• Last updated: 2017-03-28
• Results posted: 2016-12-12

Locations

1 site across 1 country: United States