Clinical trial NCT00567814: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cocaine Dependence
Cocaine Addiction
Keywords: Cocaine
Dependence
Addiction
Cortisol
GABA
Lead sponsor: Embera NeuroTherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire
timeFrame: 6 weeks
Secondary outcomes:
measure: Reduction or elimination of cocaine use as evidenced by self-report and urine toxicology
timeFrame: 6 weeks
measure: Improvement in anxiety and depression symptoms
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: Department of Psychiatry, Psychopharmacology Research Clinic
state: Louisiana
Study officials:
affiliation: LSU Health Sciences Center - Shreveport
name: Anita S Kablinger, MD
role: PRINCIPAL_INVESTIGATOR
References: