Progesterone for Postpartum Cocaine Relapse

Cocaine Dependence Clinical Trial

Official title:

Progesterone for Postpartum Cocaine Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249274
• Other study ID #: 1005006793
• Secondary ID: R21DA029914
• Status: Completed
• Phase: N/A
• First received: November 22, 2010
• Last updated: August 26, 2013
• Start date: August 2010
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

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

Intervention

Drug:
• Progesterone
100mgs progesterone twice daily

Other:
• Placebo
Matched placebo pills to be taken twice daily

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased use of cocaine	Primary aim: to evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo.	12 weeks postpartum	No
Secondary	Adverse events of progesterone among a group of postpartum women at risk for cocaine use.	To obtain information about the safety and tolerability of progesterone treatment in the postpartum period, women will be queried at every visit about onset of adverse events, their seriousness, and their relatedness to study medication. Such data will be monitored in SAETRS.	12 weeks postpartum	Yes

External Links

•   Research site webpage