Investigation of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01134198
Recruitment Status : Completed
First Posted : May 31, 2010
Last Update Posted : February 16, 2018
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:
This research will evaluate the impact of blocking central and peripheral glucocorticoid receptors on stress sensitivity and the risk of relapse to cocaine use in treatment-seeking cocaine-dependent individuals. Mifepristone (RU-486) will be the glucocorticoid antagonist used.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Mifepristone Drug: placebo Phase 2 Phase 3

Detailed Description:
This study attempts to reduce relapse risk by blocking glucocorticoid receptors, and thus allow some of the changes in the brain caused by cocaine to redress themselves

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Effects of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients
Study Start Date : May 2010
Actual Primary Completion Date : September 2016
Actual Study Completion Date : February 14, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Mifepristone
Mifepristone 600mg
Drug: Mifepristone
Mifepristone 600mg, 3x/wk for 4 weeks
Other Name: RU486

Placebo Comparator: placebo
Drug: placebo

Primary Outcome Measures :
  1. Days to relapse [ Time Frame: number of days during 8 weeks ]
    mean number of days to relapse during 8 week trial.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 to 60.
  2. Male.
  3. Meets DSM?IV criteria for current cocaine dependence and is seeking treatment.
  4. Identifies life stress (work, interpersonal, financial, etc) as a trigger for cocaine use or reports uncontrollable craving to use of cocaine.
  5. Displays at least one cocaine-positive urine toxicology during screening.
  6. Uses cocaine at least 4/30 days in the past month, or reports episodic binges of large amounts of cocaine (at least $200) at least 2x/month.
  7. Able to give informed consent and comply with study procedures.

Exclusion Criteria:

  1. Meets DSM-IV criteria for major depression, bipolar disorder, schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse. Substance Induced Mood Disorder with Hamilton Depression Scale score ³13 will be excluded.
  2. History of seizures in the last 2 years, or history of seizures related to the substance (cocaine, alcohol, or benzodiazepine) that the patient continues to use.
  3. History of allergic, dermatological, or adverse event to mifepristone
  4. Chronic organic mental disorder, insufficient proficiency in English that would render an individual incapable of giving informed consent.
  5. Significant current suicidal risks, history of significant suicidal behavior or any suicide attempt within the past year.
  6. Unstable physical disorders, which might make participation hazardous such as hypertension (>140/90), WBC < 3.5, new diagnosis of hepatitis (patients with chronic mildly elevated transaminase levels (£2-3 X upper limit of normal will be considered acceptable if PT/PTT is normal), renal failure (creat > 2; BUN > 40), or diabetes (HbA1c > 7%), and low Hb (< 12g/dL) or low Hct (<36%).
  7. Coronary vascular disease as indicated by history, or suspected by abnormal ECG or history of cardiac symptoms. Hx of cardiac symptoms (chest pain, chest pressure, shortness of breath, syncope) during cocaine use.
  8. Cardiac conduction system disease as indicated by QRS duration of ³ 0.11 msec.
  9. Currently meets DSM-IV criteria for another substance dependence or abuse disorder other than nicotine, alcohol, or cannabis. If alcohol dependent, must not be in need of detoxification. Heavy male drinkers (who consume greater than 5 standard alcoholic drink per day per NIAAA definition) will be excluded.
  10. Presents with metabolic indicators of hypoadrenalism such as low serum sodium (<130 mEq/L), high serum potassium (>5.5 mEq/L), Na/K ratio < 30:1, low fasting blood sugar (<50 mg/dL), or high BUN (>20 mg/dL), or a previous history of Addison's disease or adrenal insufficiency, or the presence of low K (< 3.5 mEq/L). spot AM cortisol <5ug/dL, PM cortisol < 3 ug/dL
  11. Participants who cannot comply with study procedures during the initial hospitalization phase.
  12. Supplemental exclusion criteria for cold pressor test (CPT): history of frostbite, open cut or sore on foot to be immersed, history of Raynaud's phenomenon. During the testing, if sBP > 190 or dBP > 120, or HR > 160, the test will be interrupted. A second occurrence of these values will stop all further CPT.

13: Patients taking medications metabolized by cytochrome 3A4 (ex: erythromycin, protease inhibitors) or that inhibit this cytochrome; or consuming grapefruit juice.

14: Patients with an underlying hemorrhagic disorder and those on anti-coagulants. INR > 1.1, PT > 17 msecs, total plt <100x109/L.

15: Use of treatment agents that inhibit steroid biosynthesis by the adrenal cortex, such as metyrapone, ketoconazole, fluconazole, aminoglutethimide, or etomidate. Patients also requiring inhaled steroids.

16. Female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01134198

United States, New York
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Principal Investigator: Wilfid N Raby, Md, PhD NYSPI

Responsible Party: New York State Psychiatric Institute Identifier: NCT01134198     History of Changes
Other Study ID Numbers: 6013
RU486 for Cocaine Dependence ( Other Grant/Funding Number: NIDA K23 DA027044-01 )
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data has been presented as an oral presentation at the annual meeting of the College on Drug Dependence in Palm Springs California on June 16th 2016. The data is presently being prepared for publication in a peer-reviewed publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: the data will be available by the end of 2018, and will be indefinitely
Access Criteria: there will be no access criteria required

Keywords provided by New York State Psychiatric Institute:
Cocaine Dependence

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
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
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists