Expired Study
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Shreveport, Louisiana 71103


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.


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


Study is Available At:


Original ID:

ECA-001


NCT ID:

NCT00567814


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Embera NeuroTherapeutics, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

45


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Anita S Kablinger, MD
Principal Investigator
LSU Health Sciences Center - Shreveport

Study Dates

Start Date:December 2007
Completion Date:November 2008
Completion Type:Actual
Primary Completion Date:November 2008
Primary Completion Type:Actual
Verification Date:December 2008
Last Changed Date:December 30, 2008
First Received Date:December 3, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Improvement in anxiety and depression symptoms
Time Frame:6 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology
Time Frame:6 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire
Time Frame:6 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Metyrapone
Description:Twice daily
Arm Name:1
Other Name:Metopirone
Intervention Type:Drug
Name:Oxazepam
Description:Twice Daily
Arm Name:1
Other Name:Serax
Intervention Type:Drug
Name:Placebo
Description:Twice daily
Arm Name:3

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:Lower dose combination of metyrapone with oxazepam
Study Arm Type:Active Comparator
Arm Name:2
Description:Higher dose combination of metyrapone with oxazepam
Study Arm Type:Placebo Comparator
Arm Name:3

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Embera NeuroTherapeutics, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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