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

Embera NeuroTherapeutics

Status: Completed

Conditions: Cocaine Dependence; Cocaine Addiction

Treatments: Drug: Placebo; Drug: Oxazepam; Drug: Metyrapone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00567814

ECA-001

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Lower dose combination of metyrapone with oxazepam

Treatment:

Drug: Metyrapone

Drug: Oxazepam

2

Active Comparator group

Description:

Higher dose combination of metyrapone with oxazepam

Treatment:

Drug: Metyrapone

Drug: Oxazepam

3

Placebo Comparator group

Treatment:

Drug: Placebo