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.
Exclusion Criteria:
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.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Embera NeuroTherapeutics, Inc.