Conditions: Cocaine Abuse Cocaine Dependence
Keywords: cocaine abuse cocaine dependence postpartum period
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Matched placebo pills to be taken twice daily arm 2: 100 mgs progesterone twice daily

Interventions: intervention 1: Progesterone intervention 2: Placebo
Intervention descriptions: intervention 1: 100mgs progesterone twice daily intervention 2: Matched placebo pills to be taken twice daily

Protocol document: