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NCT00567814
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
NA trial testing Metyrapone in Cocaine Dependence in 45 participants. Completed in 1 November 2008.
1 November 2008
Quick facts
| Lead sponsor | Embera NeuroTherapeutics, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 1 December 2007 |
| Primary completion | 1 November 2008 |
| Estimated completion | 1 November 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Metyrapone (METYRAPONE) — full drug profile →
- Oxazepam — full drug profile →
- Placebo
Conditions studied
- Cocaine Dependence — all drugs for Cocaine Dependence →
- Cocaine Addiction — all drugs for Cocaine Addiction →
Sponsor
Embera NeuroTherapeutics, Inc. — full company profile →
Who can join
Adults 18 to 50, any sex, with Cocaine Dependence or Cocaine Addiction. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Reduction or elimination of cocaine craving as evidenced by the Cocaine Craving Questionnaire
Time frame: 6 weeks
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00567814
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Metyrapone
Trials testing the same drug.
- NCT06106295 — Metyrapone for Mild Autonomous Cortisol Secretion (MACS) · Phase 2 · active not recruiting
Other recruiting trials for Cocaine Dependence
Currently open trials in the same condition.
- NCT06189690 — Effect of HF rTMS on Serum BDNF in Cocaine Use Disorder · NA · recruiting
Other Embera NeuroTherapeutics, Inc. trials
Trials by the same sponsor.
- NCT04933916 — Study of EMB-001 as a Potential Smoking Cessation Treatment · Phase 1, PHASE2 · terminated
- NCT04501874 — A Study to Evaluate EMB 001 in Subjects With Cocaine Use Disorder · Phase 2 · completed
- NCT03404817 — Single Dose Crossover Comparative Bioavailability and Food Effect Study of Two EMB-001 Formulations · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00567814 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Embera NeuroTherapeutics, Inc.
- Last refreshed: 30 December 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00567814.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing