Cocaine Use Disorder Clinical Trial
Official title:
A Phase 1b, Randomized, Double-Blinded, Multiple-Dose, Placebo Controlled, Crossover Study To Evaluate The Safety, Tolerability And Pharmacokinetic Effects Of A Metyrapone And Oxazepam Combination (EMB-001) When Co-Administered With Cocaine
EMB-001 is a combination of 2 drugs: the cortisol synthesis inhibitor, metyrapone
(Metopirone®), and the benzodiazepine receptor agonist, oxazepam (original trade name Serax®;
now marketed as oxazepam (generic) only).
This Phase 1b cocaine interaction study is being conducted in order to assess the safety and
PK of EMB-001 and cocaine in combination.
This is a single center, randomized, double-blinded, multiple-dose, PLB controlled, 2-period,
4-sequence, crossover study design.
After establishing eligibility approximately 16 subjects with cocaine use disorder will be
randomized to one of four sequences.
Treatment periods will be separated by a 7-day in-patient washout period. EMB-001/PLB will be
orally administered for 7 consecutive days, BID for 6 days (starting on Day 1 and Day 15)
followed on the last day (Day 7 and Day 21) by one EMB-001/PLB oral dose in the morning.
Infusion of 40 mg IV cocaine and IV saline-to-match cocaine infusion will be administered in
a randomized order, 2 hours apart, starting 3 hours after the last morning EMB-001/PLB oral
administration.
The subjects will be discharged from the research clinic 2 days after the last dose of
cocaine, and will have a follow-up visit 7 days after last dose.
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