Progesterone for Postpartum Cocaine Relapse

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.

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.