Cocaine Dependence, Cocaine Addiction
Conditions
Keywords
Cocaine, Dependence, Addiction, Cortisol, GABA
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.
Interventions
Sponsors
Embera NeuroTherapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cocaine Craving Questionnaire Brief | Week 1, Day 3 to Week 6, day 3 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnita S Kablinger, MD
LSU Health Sciences Center - Shreveport
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 39.5 year STANDARD_DEVIATION 8.04 |
| Cocaine use in years | 14.1 Years STANDARD_DEVIATION 10.22 |
| Cocaine use per week | 4 Events per week STANDARD_DEVIATION 2.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 45 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 15 / 15 | 15 / 15 | 15 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
None listed