Progesterone for Postpartum Cocaine Relapse

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kimberly Yonkers, Yale University
ClinicalTrials.gov Identifier:
NCT01249274
First received: November 22, 2010
Last updated: October 19, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Cocaine Abuse
Cocaine Dependence
Drug: Progesterone
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Progesterone for Postpartum Cocaine Relapse

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Mean Number of Days Per Week of Cocaine Use [ Time Frame: Weekly measurements, Baseline to 12 weeks ]
    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.

  • Number of Days of Cocaine Use Between 12 Week Visits & the 3 Month Follow up [ Time Frame: baseline, end of trial (week 12), 3-month post-trial 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

  • Proportion of Positive Urine Samples Per Week [ Time Frame: weekly measurements, baseline to 12 weeks ]
    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.

  • Proportion of Positive Urine Samples Per Week [ Time Frame: baseline, end of trial (week 12) and 3-month post-trial 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. Urine tox tests obtained qualitative and quantitative data on cocaine metabolites and other substances.


Secondary Outcome Measures:
  • Overall Comparison of Adverse Events Between Women in Placebo and Progesterone Group [ Time Frame: 12 weeks postpartum ]
    To obtain information about the safety and tolerability of progesterone treatment in the postpartum period, women were queried at every visit about onset of adverse events, their seriousness, and their relatedness to study medication. Such data was monitored in SAETRS.

  • Cocaine Craving (Measured Weekly Using CCQ-Brief) [ Time Frame: baseline to 12 weeks ]
    CCQ-Brief is a ten-item questionnaire developed from the 45-item CCQ. Each item is scored on a visual analogue scale ranging from 1-7, and items are averaged to yield a score from 1 to 7. Higher scores indicate stronger cocaine cravings.

  • Depression (Measured Weekly Using Edinburgh Postnatal Depression Scale (EPDS)) [ Time Frame: baseline to 12 weeks ]
    EPDS scores were measured to detect depression as a possible adverse event and compare scores between the two groups. The scale consists of 10 items. Each item is scored from 0 to 3, and the 10 items are summed to calculate a total score with a possible range of 0 to 30 and higher scores indicating more severe depression.

  • Salivary Progesterone Concentrations [ Time Frame: week 2, week 6, week 10, week 12 ]
    A comparison of salivary progesterone concentrations across all samples for all timepoints


Enrollment: 50
Study Start Date: August 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matched placebo pills to be taken twice daily
Other: Placebo
Matched placebo pills to be taken twice daily
Experimental: Progesterone
100 mgs progesterone twice daily
Drug: Progesterone
100mgs progesterone twice daily
Other Name: prometrium

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

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249274

Locations
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kimberly A Yonkers, MD Yale School of Medicine
Principal Investigator: Mehmet Sofuoglu, MD, PhD Yale School of Medicine
  More Information

Additional Information:
Responsible Party: Kimberly Yonkers, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01249274     History of Changes
Other Study ID Numbers: 1005006793  R21DA029914 
Study First Received: November 22, 2010
Results First Received: January 5, 2016
Last Updated: October 19, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data request should be made to the PI

Keywords provided by Yale University:
cocaine abuse
cocaine dependence
postpartum period

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Progesterone
Cocaine
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on January 19, 2017