Progesterone for Postpartum Cocaine Relapse

NCT01249274 | Completed Results DMC

• 2 other identifiers: 1005006793R21DA029914
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Abuse; Cocaine Dependence

Keywords

cocaine abuse; cocaine dependence; postpartum period

Outcome Measures

Primary Outcomes (4)

• Mean Number of Days Per Week of Cocaine Use

  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. Measured by self-reported days of cocaine use per week via substance use calendar.

  Weekly measurements, Baseline to 12 weeks

• Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up

  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. Measured by self-reported days of cocaine use per week during the trial period and during 3 month follow up using the substance use calendar

  baseline, end of trial (week 12), 3-month post-trial follow-up

• Proportion of Positive Urine Samples Per Week

  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. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.

  weekly measurements, baseline to 12 weeks

• Proportion of Positive Urine Samples Per Week

  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. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.

  baseline, end of trial (week 12) and 3-month post-trial follow-up

Secondary Outcomes (4)

• Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group

  12 weeks postpartum

• Cocaine Craving (Measured Weekly Using CCQ-Brief)

  baseline to 12 weeks

• Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS))

  baseline to 12 weeks

• Salivary Progesterone Concentrations

  week 2, week 6, week 10, week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matched placebo pills to be taken twice daily

Other: Placebo

Progesterone

EXPERIMENTAL

100 mgs progesterone twice daily

Drug: Progesterone

Interventions

Progesterone DRUG

100mgs progesterone twice daily

Also known as: prometrium

Progesterone

Placebo OTHER

Matched placebo pills to be taken twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Women will be ineligible for the trial if they:
• 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;
• have a known allergy to progesterone or peanuts (vehicle for micronized progesterone);
• speak a language other than English;
• are planning on moving out of the area in the first six months after delivery;
• are unable to understand the study or are unable to provide informed consent;
• are currently undergoing treatment with another pharmacological agent for substance abuse treatment (with the exception of methadone or buprenorphine as above);
• have pending incarceration;
• are currently incarcerated;
• are using another progestin;
• are unwilling to accept randomization;
• are unwilling to use a barrier method of birth control for the duration of the study to ensure that they will not become pregnant.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Links

• Research site webpage

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Limitations and Caveats

Women seen only once per week leading to reliance on self-reports more than urine, results of which differed; post-partum women with cocaine use disorder have other issues affecting likelihood of cocaine use; missed visits may have biased results.

Results Point of Contact

• Title: Kimberly A. Yonkers, M.D.
• Organization: Yale University

kimberly.yonkers@yale.edu

203-764-6621

Study Officials

• Kimberly A Yonkers, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Mehmet Sofuoglu, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 29, 2010
• Study Start: February 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 28, 2017
• Results First Posted: December 12, 2016

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)