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

Primary Purpose

Cocaine Dependence, Cocaine Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metyrapone
Oxazepam
Placebo
Sponsored by
Embera NeuroTherapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine, Dependence, Addiction, Cortisol, GABA

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Psychiatry, Psychopharmacology Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Lower dose combination of metyrapone with oxazepam

Higher dose combination of metyrapone with oxazepam

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology
Improvement in anxiety and depression symptoms

Full Information

First Posted
December 3, 2007
Last Updated
December 30, 2008
Sponsor
Embera NeuroTherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00567814
Brief Title
A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Embera NeuroTherapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence, Cocaine Addiction
Keywords
Cocaine, Dependence, Addiction, Cortisol, GABA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Lower dose combination of metyrapone with oxazepam
Arm Title
2
Arm Type
Active Comparator
Arm Description
Higher dose combination of metyrapone with oxazepam
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Metyrapone
Other Intervention Name(s)
Metopirone
Intervention Description
Twice daily
Intervention Type
Drug
Intervention Name(s)
Oxazepam
Other Intervention Name(s)
Serax
Intervention Description
Twice Daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Twice daily
Primary Outcome Measure Information:
Title
Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology
Time Frame
6 weeks
Title
Improvement in anxiety and depression symptoms
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita S Kablinger, MD
Organizational Affiliation
LSU Health Sciences Center - Shreveport
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Psychopharmacology Research Clinic
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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