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

NCT00567814 | Completed

• 1 other identifier: ECA-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cocaine Dependence; Cocaine Addiction

Keywords

Cocaine; Dependence; Addiction; Cortisol; GABA

Outcome Measures

Primary Outcomes (1)

• Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire

  6 weeks

Secondary Outcomes (2)

• Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology

  6 weeks

• Improvement in anxiety and depression symptoms

  6 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Lower dose combination of metyrapone with oxazepam

Drug: Metyrapone; Drug: Oxazepam

2

ACTIVE COMPARATOR

Higher dose combination of metyrapone with oxazepam

Drug: Metyrapone; Drug: Oxazepam

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Metyrapone DRUG

Twice daily

Also known as: Metopirone

1; 2

Oxazepam DRUG

Twice Daily

Also known as: Serax

1; 2

Placebo DRUG

Twice daily

3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Embera NeuroTherapeutics, Inc.: lead

Study Sites (1)

Department of Psychiatry, Psychopharmacology Research Clinic

Shreveport, Louisiana, 71103, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Behavior, Addictive

Interventions

Metyrapone; Oxazepam

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Anita S Kablinger, MD

  LSU Health Sciences Center - Shreveport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 3, 2007
• First Posted: December 5, 2007
• Study Start: December 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 31, 2008

Record last verified: 2008-12

Locations

US (1)