Clinical trial NCT02144415: A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Drug Users
Keywords: abuse liability
recreational drug user
stimulant
d-amphetamine
ADHD
Lead sponsor: Euthymics BioScience, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-22
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum effect (Emax) on Drug Liking visual analog scale (VAS)
timeFrame: within 24 hours post-dose
Secondary outcomes:
measure: Drug Liking VAS (minimum effect [Emin] and time-averaged area under the effect curve to 12 hours after study drug administration [TA_AUE])
timeFrame: within 24 hours post-dose
measure: Overall Drug Liking VAS (Emax/Emin)
timeFrame: within 24 hours post-dose
measure: Take Drug Again VAS (Emax)
timeFrame: within 24 hours post-dose
measure: High VAS (Emax and TA_AUE)
timeFrame: within 24 hours post-dose
measure: Good Effects VAS (Emax and TA_AUE)
timeFrame: within 24 hours post-dose
measure: Bad Effects VAS (Emax and TA_AUE)
timeFrame: within 24 hours post-dose
measure: Nausea VAS (Emax and TA_AUE)
timeFrame: within 24 hours post-dose
measure: ARCI-A scale (Emax and TA_AUE)
timeFrame: within 24 hours post-dose
measure: ARCI-BG scale (Emax and TA_AUE)
timeFrame: within 24 hours post-dose
measure: Alertness/Drowsiness VAS (Emax and TA_AUE)
timeFrame: within 24 hours post-dose
measure: Agitation/Relaxation VAS (Emax and TA_AUE)
timeFrame: within 24 hours post-dose
measure: Any Effects VAS (Emax and TA_AUE)
timeFrame: within 24 hours post-dose
measure: Drug Similarity VAS (score at 12 hours after study drug administration)
timeFrame: within 24 hours post-dose
measure: Safety and tolerability of EB-1020 as assessed by AEs
timeFrame: Up to 6 weeks
measure: Safety and tolerability of EB-1020 by laboratory assessments
timeFrame: Up to 6 weeks
measure: Safety and tolerability of EB-1020 as assessed by 12-lead ECGs
timeFrame: Up to 6 weeks
measure: Safety and tolerability of EB-1020 as assessed by vital signs
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research, Inc.
state: Kansas
Study officials:
References: