DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Euthymics BioScience, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers; Drug Users

Intervention: EB-1020 400 mg (Drug); EB-1020 800 mg (Drug); lisdexamfetamine 150 mg (Drug); d-amphetamine 40 mg (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Neurovance, Inc.


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).

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

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

Overall Drug Liking VAS (Emax/Emin)

Take Drug Again VAS (Emax)

High VAS (Emax and TA_AUE)

Good Effects VAS (Emax and TA_AUE)

Bad Effects VAS (Emax and TA_AUE)

Nausea VAS (Emax and TA_AUE)

ARCI-A scale (Emax and TA_AUE)

ARCI-BG scale (Emax and TA_AUE)

Alertness/Drowsiness VAS (Emax and TA_AUE)

Agitation/Relaxation VAS (Emax and TA_AUE)

Any Effects VAS (Emax and TA_AUE)

Drug Similarity VAS (score at 12 hours after study drug administration)

Safety and tolerability of EB-1020 as assessed by AEs

Safety and tolerability of EB-1020 by laboratory assessments

Safety and tolerability of EB-1020 as assessed by 12-lead ECGs

Safety and tolerability of EB-1020 as assessed by vital signs

Detailed description: Subjects will be randomized to 1 of 10 treatment sequences according to a two 5 x 5 William squares design. To maintain blinding, subjects will be required to ingest eight capsules with approximately 240 mL water on each study drug administration day. Serial pharmacodynamic (PD) evaluations will be conducted up to 24 hours after each study drug administration. Pharmacokinetic (PK) samples will be obtained to confirm exposure to EB-1020. Safety monitoring will include recording of adverse events (AEs), regular assessments of vital signs measurements, 12-lead electrocardiogram (ECG) findings, and continuous telemetry monitoring for at least 3 hours after study drug administration.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.


Inclusion Criteria: 1. Subjects must be healthy male nondependent recreational drug users 2. Subjects must be 18 to 55 years old, inclusive. 3. 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: 1. Subjects that are deemed medically unsuitable or unlikely to comply with the study protocol for any reason. 2. Subjects who do not pass Qualification Phase criteria to be eligible for the Treatment Phase.

Locations and Contacts

Vince and Associates Clinical Research, Inc., Overland Park, Kansas 66212, United States
Additional Information

Starting date: May 2014
Last updated: August 13, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017