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

NCT01134198 | Completed Phase 2 Results DMC

• 2 other identifiers: 6013RU486 for Cocaine Dependence
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Dependence

Keywords

Cocaine Dependence

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Relapse by Days 10 and 28

  assessed percent of sample with documented cocaine use by days 10 and 28 based on self reported use and urine toxicology. Those with documented use were considered to have relapsed.

  assessed during 8 weeks of trial, but reported for days 10 and 28 of trial

Study Arms (2)

Mifepristone

ACTIVE COMPARATOR

Mifepristone 600mg

Drug: Mifepristone

placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

Mifepristone DRUG

Mifepristone 600mg, 3x/wk for 4 weeks

Also known as: RU486

Mifepristone

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• : Patients taking medications metabolized by cytochrome 3A4 (ex: erythromycin, protease inhibitors) or that inhibit this cytochrome; or consuming grapefruit juice.
• : Patients with an underlying hemorrhagic disorder and those on anti-coagulants. INR \> 1.1, PT \> 17 msecs, total plt \<100x109/L.
• : 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

STARS

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: wilfrid raby, md
• Organization: new york state psychiatric institute

wilfrid.raby@nyspi.columbia.edu

212-923-3031

Study Officials

• Wilfid N Raby, Md, PhD

  NYSPI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 31, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: February 14, 2018
• Last Updated: December 20, 2018
• Results First Posted: August 24, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

US (1)