Investigation of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
New York State Psychiatric Institute
First received: May 26, 2010
Last updated: June 6, 2014
Last verified: April 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Investigation of the Effects of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2015 (Final data collection date for primary outcome measure)
Active Comparator: Mifepristone
Mifepristone 600mg, 3x/wk for 4 weeks
Other Name: RU486
Placebo Comparator: placebo
Other Name: placebo
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
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Age 18 to 60.
- Meets DSM?IV criteria for current cocaine dependence and is seeking treatment.
- Identifies life stress (work, interpersonal, financial, etc) as a trigger for cocaine use or reports uncontrollable craving to use of cocaine.
- Displays at least one cocaine-positive urine toxicology during screening.
- 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.
- Able to give informed consent and comply with study procedures.
- 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.
- 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.
- History of allergic, dermatological, or adverse event to mifepristone
- Chronic organic mental disorder, insufficient proficiency in English that would render an individual incapable of giving informed consent.
- Significant current suicidal risks, history of significant suicidal behavior or any suicide attempt within the past year.
- 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%).
- 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.
- Cardiac conduction system disease as indicated by QRS duration of ³ 0.11 msec.
- 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.
- 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
- Participants who cannot comply with study procedures during the initial hospitalization phase.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01134198
|New York, New York, United States, 10032 |
New York State Psychiatric Institute
||Wilfid N Raby, Md, PhD
No publications provided
||New York State Psychiatric Institute
History of Changes
|Other Study ID Numbers:
||6013, RU486 for Cocaine Dependence
|Study First Received:
||May 26, 2010
||June 6, 2014
||United States: Food and Drug Administration
Keywords provided by New York State Psychiatric Institute:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 24, 2014
Abortifacient Agents, Steroidal
Central Nervous System Agents
Central Nervous System Depressants
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Dopamine Uptake Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents