Investigation of Mifepristone (RU486) on Stress Sensitivity and Relapse Prevention in Cocaine Dependent Patients
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Relapse by Days 10 and 28 |
3; 8; 6; 3; 5; 8 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 60.
- Male.
- 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.
Exclusion Criteria
- 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 2; BUN > 40), or diabetes (HbA1c > 7%), and low Hb ( 5.5 mEq/L), Na/K ratio 20 mg/dL), or a previous history of Addison's disease or adrenal insufficiency, or the presence of low K ( 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.
- Female
Data sourced from ClinicalTrials.gov (NCT01134198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.