Cocaine DependenceNCT00567814
A Placebo-Controlled Study of a Combination of Metyrapone and Oxazepam in Cocaine Addiction
A study testing Metyrapone and Oxazepam in people with Cocaine Dependence and Cocaine Addiction, run by Embera NeuroTherapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Dependence, Cocaine Addiction
- What is being tested?
- Metyrapone and Oxazepam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Nov 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry, Psychopharmacology Research Clinic
Shreveport, Louisiana, 71103
About this study
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
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
- Being tested
- Metyrapone, Oxazepam, Placebo
- Keywords
- Cocaine, Dependence, Addiction, Cortisol, GABA
- Medical subject headings
- Cocaine-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetyraponeDrug
Also called Metopirone
Twice daily
OxazepamDrug
Also called Serax
Twice Daily
PlaceboDrug
Twice daily
| Study group | Role | What they receive |
|---|---|---|
| Metyrapone 500 mg oxazepam 20 mg | Active comparator | Lower dose combination of metyrapone with oxazepam, total daily dose Receives: Drug: Metyrapone; Drug: Oxazepam |
| Metyrapone 1500 mg oxazepam 20 mg | Active comparator | Higher dose combination of metyrapone with oxazepam, total daily dose Receives: Drug: Metyrapone; Drug: Oxazepam |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1, Day 3 to Week 6, day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Embera NeuroTherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anita S Kablinger, MD, Principal investigator, LSU Health Sciences Center - Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567814
- Sponsor's protocol ID
- ECA-001
- Status last verified
- Aug 2026
- First submitted
- 3 Dec 2007
- Last updated
- 18 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00567814
- Acronym / sponsor ID
- ECA-001
- Conditions
- Cocaine Dependence, Cocaine Addiction
- Keywords
- Cocaine, Dependence, Addiction, Cortisol, GABA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Embera NeuroTherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Posted 18 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metyrapone 500 mg oxazepam 20 mg | Active comparator | Drug: Metyrapone, Drug: OxazepamLower dose combination of metyrapone with oxazepam, total daily dose |
| Metyrapone 1500 mg oxazepam 20 mg | Active comparator | Drug: Metyrapone, Drug: OxazepamHigher dose combination of metyrapone with oxazepam, total daily dose |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetyraponeAlso: MetopironeTwice daily | Drug | Metyrapone 1500 mg oxazepam 20 mg, Metyrapone 500 mg oxazepam 20 mg |
| OxazepamAlso: SeraxTwice Daily | Drug | Metyrapone 1500 mg oxazepam 20 mg, Metyrapone 500 mg oxazepam 20 mg |
| PlaceboTwice daily | Drug | Placebo |
Primary outcome
Change in Cocaine Craving Questionnaire Brief
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cocaine Dependence
Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
Active, not recruitingPhase 1
AAV8-hCocH for Cocaine Use Disorder
Cocaine Dependence, in Remission
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita S Kablinger, MD principal investigator
LSU Health Sciences Center - Shreveport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metyrapone and Oxazepam in people with Cocaine Dependence and Cocaine Addiction, run by Embera NeuroTherapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cocaine Craving Questionnaire Brief (time frame: Week 1, Day 3 to Week 6, day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.