A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction - Full Text View

Sponsored by:	Embera NeuroTherapeutics, Inc.
Information provided by:	Embera NeuroTherapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00567814

Purpose

Subjects will be randomly assigned to receive either one of the two potential dose combinations of the study medications or placebo over 6 weeks. The study will include twice weekly visits to the research clinic for laboratory studies, safety assessments and urine drug screens. Subjects will also be questioned regarding drug craving and mood symptoms.

Condition	Intervention
Cocaine Dependence Cocaine Addiction	Drug: Metyrapone Drug: Oxazepam Drug: Placebo

MedlinePlus related topics: Urine and Urination

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Metyrapone Oxazepam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Two Dose Combinations of Metyrapone and Oxazepam in the Treatment of Cocaine Addiction

Further study details as provided by Embera NeuroTherapeutics, Inc.:

Primary Outcome Measures:

Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Improvement in anxiety and depression symptoms [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	December 2007
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Lower dose combination of metyrapone with oxazepam	Drug: Metyrapone Twice daily Drug: Oxazepam Twice Daily
2: Active Comparator Higher dose combination of metyrapone with oxazepam	Drug: Metyrapone Twice daily Drug: Oxazepam Twice Daily
3: Placebo Comparator	Drug: Placebo Twice daily

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, 18 - 50 years of age
Requests treatment for cocaine addiction
Meets the DSM-IV criteria for cocaine dependency
Able to provide written informed consent and comply with the study
Females of childbearing potential must have a negative pregnancy test and must be using adequate birth control during the study
Test positive for cocaine on a urinary drug screen
Healthy and medically stable in the opinion of the Principal Investigator

Exclusion Criteria:

Liver enzymes greater than two times normal
Any history of hepatitis
History of disorders requiring chronic treatment with steroids
Significantly abnormal ECG
Any prominent DSM-IV axis I disorders other than cocaine dependence
Any subject who presents as a danger to self or others in the opinion of the Principal Investigator
Concomitant use of methamphetamine as determined by self-reporting and verified by measurement of methamphetamine in urinary drug screen
Alcohol consumption greater than 4 drinks per day (1 Drink = 12 oz beer; 5 oz wine; 1.5 oz shot of liquor)
Any clinically significant laboratory test abnormalities
Use of any concomitant medication during the study that would interfere with study medications
Serum cortisol less than 3 µg/dl at any time before or during study
Treatment with an investigational product within 30 days prior to study enrollment
Currently seeking other forms of professional addiction treatment
Known allergic reaction to oxazepam or metyrapone
Lactose intolerance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567814

Locations

United States, Louisiana
Department of Psychiatry, Psychopharmacology Research Clinic
Shreveport, Louisiana, United States, 71103

Sponsors and Collaborators

Embera NeuroTherapeutics, Inc.

Investigators

Principal Investigator:

Anita S Kablinger, MD

LSU Health Sciences Center - Shreveport

More Information

Responsible Party:	Embera NeuroTherapeutics, Inc. ( Marie Lindner, MD/Medical Monitor )
Study ID Numbers:	ECA-001
Study First Received:	December 3, 2007
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00567814
Health Authority:	United States: Institutional Review Board

Keywords provided by Embera NeuroTherapeutics, Inc.:

Cocaine
Dependence
Addiction
Cortisol
GABA

Study placed in the following topic categories:

Cocaine-Related Disorders
Behavior, Addictive
Hydrocortisone
Cortisol succinate
Oxazepam
Disorders of Environmental Origin
Impulsive Behavior

Compulsive Behavior
Dopamine
Metyrapone
Mental Disorders
Substance-Related Disorders
Hydrocortisone acetate
Cocaine

Additional relevant MeSH terms:

Antimetabolites
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Central Nervous System Depressants
Enzyme Inhibitors

Cardiovascular Agents
Pharmacologic Actions
Anesthetics, Local
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Vasoconstrictor Agents
GABA Agents
Anti-Anxiety Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009