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

NCT02144415 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-13

No results posted yet for this study

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).

Conditions

  • Healthy Volunteers
  • Drug Users

Interventions

DRUG

EB-1020 400 mg

4 x EB-1020 100-mg capsules, and 4 matching placebo capsules

DRUG

EB-1020 800 mg

8 x EB-1020 100-mg capsules

DRUG

lisdexamfetamine 150 mg

3 x capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 x matching placebo capsules

DRUG

d-amphetamine 40 mg

4 x capsules, each containing 2 d-amphetamine 5-mg tablets, and 4 x matching placebo capsules

DRUG

Placebo

8 x matching placebo capsules

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-01
Primary Completion
2014-07-01
Completion
2014-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02144415 on ClinicalTrials.gov