Progesterone for Postpartum Cocaine Relapse

NCT ID: NCT01249274

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-07-31

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.

Conditions

Cocaine Abuse; Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Matched placebo pills to be taken twice daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matched placebo pills to be taken twice daily

Progesterone

100 mgs progesterone twice daily

Group Type: EXPERIMENTAL

Progesterone

Intervention Type: DRUG

100mgs progesterone twice daily

Interventions

Progesterone

100mgs progesterone twice daily

Intervention Type: DRUG

Placebo

Matched placebo pills to be taken twice daily

Intervention Type: OTHER

Other Intervention Names

prometrium

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Yonkers

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly A Yonkers, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Mehmet Sofuoglu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

R21DA029914

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1005006793

Identifier Type: -

Identifier Source: org_study_id