An interventional study of Metyrapone and Oxazepam in Cocaine Dependence and Cocaine Addiction, sponsored by Embera NeuroTherapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Embera NeuroTherapeutics, Inc. · Not applicable, Interventional, and Treatment
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.
416 studies on the registry are indexed under Cocaine-Related Disorders; 12 are open to participants now.
This study's enrollment of 45 is below the median of 60 across 313 interventional studies indexed under Cocaine-Related Disorders.
Browse Cocaine-Related Disorders studies →Embera NeuroTherapeutics, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lower dose combination of metyrapone with oxazepam, total daily dose
Drug: Metyrapone · Drug: Oxazepam
Higher dose combination of metyrapone with oxazepam, total daily dose
Drug: Metyrapone · Drug: Oxazepam
Placebo
Drug: Placebo
Twice daily
Also known as: Metopirone
Twice Daily
Also known as: Serax
Twice daily
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.
Time frame: Week 1, Day 3 to Week 6, day 3
| Milestone | Metyrapone 500 mg Oxazepam 20 mg | Metyrapone 1500 mg Oxazepam 20 mg | Placebo |
|---|---|---|---|
| Started | 15 | 15 | 15 |
| Efficacy evaluable | 9 | 8 | 9 |
| Completed | 6 | 7 | 9 |
| Not completed | 9 | 8 | 6 |
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.
| Change in scores on scale | Metyrapone 500 mg Oxazepam 20 mg | Metyrapone 1500 mg Oxazepam 20 mg | Placebo |
|---|---|---|---|
| Change in Cocaine Craving Questionnaire Brief | -0.5 ± 0.74 | -0.8 ± 1.34 | -0.6 ± 1.16 |
Collected over With an onset date after first administration of study treatment will be collected through the follow-up visit (up to 7 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metyrapone 500 mg Oxazepam 20 mg | 0/15 (0%) | 0/15 (0%) | 15/15 (100%) |
| Metyrapone 1500 mg Oxazepam 20 mg | 0/15 (0%) | 0/15 (0%) | 15/15 (100%) |
| Placebo | 0/15 (0%) | 0/15 (0%) | 15/15 (100%) |
| Event | Metyrapone 500 mg Oxazepam 20 mg | Metyrapone 1500 mg Oxazepam 20 mg | Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 5/15 | 2/15 | 3/15 |
| NauseaGastrointestinal disorders | 4/15 | 4/15 | 1/15 |
| IrritabilityGeneral disorders | 2/15 | 4/15 | 1/15 |
| SomnolencePsychiatric disorders | 4/15 | 2/15 | 2/15 |
| InsomniaNervous system disorders | 3/15 | 0/15 | 0/15 |
| DiarrhoeaGastrointestinal disorders | 2/15 | 0/15 | 3/15 |
| Abdominal pain upperGastrointestinal disorders | 0/15 | 1/15 | 3/15 |
| ToothacheGastrointestinal disorders | 1/15 | 2/15 | 0/15 |
| Dry mouthGastrointestinal disorders | 2/15 | 2/15 | 2/15 |
| VomitingGastrointestinal disorders | 1/15 | 0/15 | 2/15 |
Safety population
| Age, Continuous(year) | Metyrapone 500mg Oxazepam 20mg | Metyrapone 1500 mg Oxazepam 20 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 39.7 ± 8.8 | 39.5 ± 7.74 | 39.3 ± 8.1 | 39.5 ± 8.04 |
| Sex: Female, Male(Participants) | Metyrapone 500mg Oxazepam 20mg | Metyrapone 1500 mg Oxazepam 20 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 3 | 6 | 5 | 14 |
| Male | 12 | 9 | 10 | 31 |
| Race (NIH/OMB)(Participants) | Metyrapone 500mg Oxazepam 20mg | Metyrapone 1500 mg Oxazepam 20 mg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 8 | 10 | 7 | 25 |
| White | 7 | 5 | 8 | 20 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Metyrapone 500mg Oxazepam 20mg | Metyrapone 1500 mg Oxazepam 20 mg | Placebo | Total |
|---|---|---|---|---|
| United States | 15 | 15 | 15 | 45 |
| Cocaine use in years(Years) | Metyrapone 500mg Oxazepam 20mg | Metyrapone 1500 mg Oxazepam 20 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 13.1 ± 7.2 | 14.1 ± 10.22 | 13.9 ± 12.5 | 13.7 ± 8.21 |
| Cocaine use per week(Events per week) | Metyrapone 500mg Oxazepam 20mg | Metyrapone 1500 mg Oxazepam 20 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 4 ± 2.12 | 2.3 ± 2.05 | 4.2 ± 2.33 | 3.5 ± 3 |
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Metyrapone · Oxazepam
Embera NeuroTherapeutics, Inc.