CompletedPhase 1

A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users

United States80 participantsStarted 2014-05-01

Plain-language summary

This single-center study will be a single-dose, randomized, double-blind, placebo- and active-controlled crossover study with a single inpatient treatment visit. The abuse potential of single oral doses of EB-1020 IR (400 mg, 800 mg) will be compared with that of placebo and d-amphetamine (20 mg, 40 mg; active control) in healthy recreational stimulant users. Subjects will participate in a medical Screening visit (Visit 1), one 4-day inpatient Qualification Phase (Visit 2), one 11-day inpatient Treatment Phase (Visit 3), and a safety Follow-up visit (Visit 4).

Who can participate

Age range18 Years – 55 Years

SexMALE

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Inclusion criteria

✓. Subjects must be healthy male nondependent recreational drug users
✓. Subjects must be 18 to 55 years old, inclusive.
✓. Subjects must have greater than or equal to 10 lifetime nontherapeutic experiences with central nervous system (CNS) stimulants (e.g., amphetamines, cocaine, methylphenidate), greater than or equal to 1 nontherapeutic use of prescription stimulants within the 12 months prior to Screening, and greater than or equal to 1 nontherapeutic use of a CNS stimulant within the 12 weeks prior to Screening.

Exclusion criteria

✕. Subjects that are deemed medically unsuitable or unlikely to comply with the study protocol for any reason.
✕. Subjects who do not pass Qualification Phase criteria to be eligible for the Treatment Phase.

What they're measuring

Maximum effect (Emax) on Drug Liking visual analog scale (VAS)

Timeframe: within 24 hours post-dose

Trial details

NCT IDNCT02144415

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-07-01

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