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

NCT02144415 | Completed Phase 1

• 1 other identifier: EB-1020 IR-103
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

abuse liability; recreational drug user; stimulant; d-amphetamine; ADHD

Outcome Measures

Primary Outcomes (1)

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

  Drug liking VAS is one of the measures of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm).

  within 24 hours post-dose

Secondary Outcomes (17)

• Drug Liking VAS (minimum effect [Emin] and time-averaged area under the effect curve to 12 hours after study drug administration [TA_AUE])

  within 24 hours post-dose

• Overall Drug Liking VAS (Emax/Emin)

  within 24 hours post-dose

• Take Drug Again VAS (Emax)

  within 24 hours post-dose

• High VAS (Emax and TA_AUE)

  within 24 hours post-dose

• Good Effects VAS (Emax and TA_AUE)

  within 24 hours post-dose

Study Arms (5)

EB-1020 400 mg

EXPERIMENTAL

EB-1020 400 mg, administered as four 100-mg IR capsules and 4 matching placebo capsules

Drug: EB-1020 400 mg

EB-1020 800 mg

EXPERIMENTAL

EB-1020 800 mg, administered as eight 100-mg IR capsules

Drug: EB-1020 800 mg

lisdexamfetamine 150 mg

ACTIVE COMPARATOR

lisdexamfetamine 150 mg, administered as 3 capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 matching placebo capsules

Drug: lisdexamfetamine 150 mg

d-amphetamine 40 mg

ACTIVE COMPARATOR

d-amphetamine 40 mg, administered as 4 capsules, each containing two 5-mg d-amphetamine tablets and 4 matching placebo capsules

Drug: d-amphetamine 40 mg

Placebo

PLACEBO COMPARATOR

Placebo, administered as 8 matching placebo capsules

Drug: Placebo

Interventions

EB-1020 400 mg DRUG

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

EB-1020 400 mg

EB-1020 800 mg DRUG

8 x EB-1020 100-mg capsules

EB-1020 800 mg

lisdexamfetamine 150 mg DRUG

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

lisdexamfetamine 150 mg

d-amphetamine 40 mg DRUG

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

d-amphetamine 40 mg

Placebo DRUG

8 x matching placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

Vince and Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

Location

Related Links

• Otsuka Clinical Trial Website
• Otsuka Clinical Trial Transparency

MeSH Terms

Conditions

Drug Misuse; Attention Deficit Disorder with Hyperactivity

Interventions

1-(naphthalen-2-yl)-3-azabicyclo(3.1.0)hexane; Lisdexamfetamine Dimesylate; Dextroamphetamine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 22, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)