Healthy VolunteersPhase 1NCT02144415
A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users
A Phase 1 study testing EB-1020 400 mg, EB-1020 800 mg and lisdexamfetamine 150 mg in people with Healthy Volunteers and Drug Users, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Drug Users
- What is being tested?
- EB-1020 400 mg, EB-1020 800 mg and lisdexamfetamine 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2014to 1 Jul 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince and Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
About this study
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).
Read the 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.
- Conditions
- Healthy Volunteers, Drug Users
- Being tested
- EB-1020 400 mg, EB-1020 800 mg, lisdexamfetamine 150 mg, d-amphetamine 40 mg, Placebo
- Keywords
- abuse liability, recreational drug user, stimulant, d-amphetamine, ADHD
- Medical subject headings
- Drug Misuse, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-1020 400 mgDrug
4 x EB-1020 100-mg capsules, and 4 matching placebo capsules
EB-1020 800 mgDrug
8 x EB-1020 100-mg capsules
lisdexamfetamine 150 mgDrug
3 x capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 x matching placebo capsules
d-amphetamine 40 mgDrug
4 x capsules, each containing 2 d-amphetamine 5-mg tablets, and 4 x matching placebo capsules
PlaceboDrug
8 x matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| EB-1020 400 mg | Experimental | EB-1020 400 mg, administered as four 100-mg IR capsules and 4 matching placebo capsules Receives: Drug: EB-1020 400 mg |
| EB-1020 800 mg | Experimental | EB-1020 800 mg, administered as eight 100-mg IR capsules Receives: 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 Receives: 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 Receives: Drug: d-amphetamine 40 mg |
| Placebo | Placebo comparator | Placebo, administered as 8 matching placebo capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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])
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).
Measured: within 24 hours post-dose
Overall Drug Liking VAS (Emax/Emin)
Overall drug liking VAS is one of the measures of balance of effects that assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm bipolar VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm= "neither like nor dislike", and 100 mm= "strong liking").
Measured: within 24 hours post-dose
Take Drug Again VAS (Emax)
Take drug again VAS is one of the measures of balance of effects. It is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm bipolar VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely not", 50 mm = "do not care", and 100 mm = "definitely so").
Measured: within 24 hours post-dose
High VAS (Emax and TA_AUE)
High VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 = definitely so).
Measured: within 24 hours post-dose
Good Effects VAS (Emax and TA_AUE)
Good drug effects VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).
Measured: within 24 hours post-dose
Bad Effects VAS (Emax and TA_AUE)
Bad effects VAS is one of the measures of negative effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).
Measured: within 24 hours post-dose
Nausea VAS (Emax and TA_AUE)
Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Measured: within 24 hours post-dose
ARCI-A scale (Emax and TA_AUE)
ARCI-A is measure of other stimulant effects. It is a set of 13 questions in which each question contributes to total score. Participants select 'False' / 'True' for response. One point given for each response that agrees with scoring direction, true items receive score of 1 if answer 'True', false items receive score of 1 if answer 'False'. No points if answer is opposite to scoring direction. Score range: 0 to 13, higher score indicated higher other subjective effects.
Measured: within 24 hours post-dose
ARCI-BG scale (Emax and TA_AUE)
ARCI-BG is measure of other subjective effects. It is a set of 13 questions in which each question contributes to total score. Participants select 'False' / 'True' for response. One point given for each response that agrees with scoring direction, true items receive score of 1 if answer 'True', false items receive score of 1 if answer 'False'. No points if answer is opposite to scoring direction. Score range: 0 to 13, higher score indicated higher other subjective effects.
Measured: within 24 hours post-dose
Alertness/Drowsiness VAS (Emax and TA_AUE)
Alertness/Drowsiness VAS is one of the measures of sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither drowsy nor alert" (score of 50 mm), on the left with "very drowsy" (score of 0 mm) and on the right with "very alert" (score of 100 mm).
Measured: within 24 hours post-dose
Agitation/Relaxation VAS (Emax and TA_AUE)
Agitation/Relaxation VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Measured: within 24 hours post-dose
Any Effects VAS (Emax and TA_AUE)
Any drug effects VAS is one of the measures of other subjective effects. It assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so).
Measured: within 24 hours post-dose
Drug Similarity VAS (score at 12 hours after study drug administration)
Drug similarity VAS is one of the measures of other subjective effects. It assesses the similarity of the drug recently received by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= not at all similar) to 'extremely' (score of 100 mm= very similar). Recently received drugs were compared with placebo, benzodiazepines, codeine/morphine, Tetrahydrocannabinol (THC), pseudoephedrine.
Measured: within 24 hours post-dose
Safety and tolerability of EB-1020 as assessed by AEs
Measured: Up to 6 weeks
Safety and tolerability of EB-1020 by laboratory assessments
Measured: Up to 6 weeks
Safety and tolerability of EB-1020 as assessed by 12-lead ECGs
Measured: Up to 6 weeks
Safety and tolerability of EB-1020 as assessed by vital signs
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study start1 May 2014
- Primary completion1 Jul 2014
- Study completion1 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144415
- Sponsor's protocol ID
- EB-1020 IR-103
- Status last verified
- Apr 2026
- First submitted
- 16 May 2014
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Abuse Potential of EB-1020 Immediate-Release in Healthy Recreational Stimulant Users
- ClinicalTrials.gov ID
- NCT02144415
- Acronym / sponsor ID
- EB-1020 IR-103
- Conditions
- Healthy Volunteers, Drug Users
- Keywords
- abuse liability, recreational drug user, stimulant, d-amphetamine, ADHD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2014 (actual)
- Primary completion
- 1 Jul 2014 (actual)
- Study completion
- 1 Jul 2014 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| EB-1020 400 mg | Experimental | Drug: EB-1020 400 mgEB-1020 400 mg, administered as four 100-mg IR capsules and 4 matching placebo capsules |
| EB-1020 800 mg | Experimental | Drug: EB-1020 800 mgEB-1020 800 mg, administered as eight 100-mg IR capsules |
| lisdexamfetamine 150 mg | Active comparator | Drug: lisdexamfetamine 150 mglisdexamfetamine 150 mg, administered as 3 capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 matching placebo capsules |
| d-amphetamine 40 mg | Active comparator | Drug: d-amphetamine 40 mgd-amphetamine 40 mg, administered as 4 capsules, each containing two 5-mg d-amphetamine tablets and 4 matching placebo capsules |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, administered as 8 matching placebo capsules |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EB-1020 400 mg4 x EB-1020 100-mg capsules, and 4 matching placebo capsules | Drug | EB-1020 400 mg |
| EB-1020 800 mg8 x EB-1020 100-mg capsules | Drug | EB-1020 800 mg |
| lisdexamfetamine 150 mg3 x capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 x matching placebo capsules | Drug | lisdexamfetamine 150 mg |
| d-amphetamine 40 mg4 x capsules, each containing 2 d-amphetamine 5-mg tablets, and 4 x matching placebo capsules | Drug | d-amphetamine 40 mg |
| Placebo8 x matching placebo capsules | Drug | Placebo |
Primary outcome
Maximum effect (Emax) on Drug Liking visual analog scale (VAS)
Time frame: within 24 hours post-dose
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).
17 secondary outcomes
Drug Liking VAS (minimum effect [Emin] and time-averaged area under the effect curve to 12 hours after study drug administration [TA_AUE])
Time frame: within 24 hours post-dose
Overall Drug Liking VAS (Emax/Emin)
Time frame: within 24 hours post-dose
Take Drug Again VAS (Emax)
Time frame: within 24 hours post-dose
High VAS (Emax and TA_AUE)
Time frame: within 24 hours post-dose
Good Effects VAS (Emax and TA_AUE)
Time frame: within 24 hours post-dose
Bad Effects VAS (Emax and TA_AUE)
Time frame: within 24 hours post-dose
Nausea VAS (Emax and TA_AUE)
Time frame: within 24 hours post-dose
ARCI-A scale (Emax and TA_AUE)
Time frame: within 24 hours post-dose
ARCI-BG scale (Emax and TA_AUE)
Time frame: within 24 hours post-dose
Alertness/Drowsiness VAS (Emax and TA_AUE)
Time frame: within 24 hours post-dose
Agitation/Relaxation VAS (Emax and TA_AUE)
Time frame: within 24 hours post-dose
Any Effects VAS (Emax and TA_AUE)
Time frame: within 24 hours post-dose
Drug Similarity VAS (score at 12 hours after study drug administration)
Time frame: within 24 hours post-dose
Safety and tolerability of EB-1020 as assessed by AEs
Time frame: Up to 6 weeks
Safety and tolerability of EB-1020 by laboratory assessments
Time frame: Up to 6 weeks
Safety and tolerability of EB-1020 as assessed by 12-lead ECGs
Time frame: Up to 6 weeks
Safety and tolerability of EB-1020 as assessed by vital signs
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Otsuka Clinical Trial WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EB-1020 400 mg, EB-1020 800 mg and lisdexamfetamine 150 mg in people with Healthy Volunteers and Drug Users, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum effect (Emax) on Drug Liking visual analog scale (VAS) (time frame: within 24 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.