Clinical trial NCT01249274: Progesterone for Postpartum Cocaine Relapse
Official title: Progesterone for Postpartum Cocaine Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Abuse
Cocaine Dependence
Keywords: cocaine abuse
cocaine dependence
postpartum period
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-11-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Mean Number of Days Per Week of Cocaine Use
timeFrame: Weekly measurements, Baseline to 12 weeks
measure: Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up
timeFrame: baseline, end of trial (week 12), 3-month post-trial follow-up
measure: Proportion of Positive Urine Samples Per Week
timeFrame: weekly measurements, baseline to 12 weeks
measure: Proportion of Positive Urine Samples Per Week
timeFrame: baseline, end of trial (week 12) and 3-month post-trial follow-up
Secondary outcomes:
measure: Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group
timeFrame: 12 weeks postpartum
measure: Cocaine Craving (Measured Weekly Using CCQ-Brief)
timeFrame: baseline to 12 weeks
measure: Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))
timeFrame: baseline to 12 weeks
measure: Salivary Progesterone Concentrations
timeFrame: week 2, week 6, week 10, week 12
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Kimberly A Yonkers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Mehmet Sofuoglu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: