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

NCT00567814 | Completed Results

• 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)

• Change in Cocaine Craving Questionnaire Brief

  The Cocaine Craving Questionnaire Brief (CCQ-Brief) is an abbreviated version of the CCQ-Now that includes ten items (CCQ-Now includes 45 items). The scale measures cocaine craving symptoms. The 10 items are scored on a one to seven scale with 8 positively-keyed items and two negatively-keyed items. The score is the sum of the individual items divided by 10 (lowest possible score, indicating lowest level of cocaine craving) is 1 and highest possible total score (indicating the highest level of cocaine craving, is 10). There are no subscores.

  Week 1, Day 3 to Week 6, day 3

Study Arms (3)

Metyrapone 500 mg oxazepam 20 mg

ACTIVE COMPARATOR

Lower dose combination of metyrapone with oxazepam, total daily dose

Drug: Metyrapone; Drug: Oxazepam

Metyrapone 1500 mg oxazepam 20 mg

ACTIVE COMPARATOR

Higher dose combination of metyrapone with oxazepam, total daily dose

Drug: Metyrapone; Drug: Oxazepam

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Metyrapone DRUG

Twice daily

Also known as: Metopirone

Metyrapone 1500 mg oxazepam 20 mg; Metyrapone 500 mg oxazepam 20 mg

Oxazepam DRUG

Twice Daily

Also known as: Serax

Metyrapone 1500 mg oxazepam 20 mg; Metyrapone 500 mg oxazepam 20 mg

Placebo DRUG

Twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Results Point of Contact

• Title: Nicholas E. Goeders, Ph.D.
• Organization: LSU Health - Shreveport

nicholas.goeders@lsuhs.edu

Study Officials

• Anita S Kablinger, MD

  LSU Health Sciences Center - Shreveport

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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
• Responsible Party: SPONSOR

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: September 18, 2026
• Results First Posted: September 18, 2026

Record last verified: 2026-08

Locations

US (1)