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

13 agosto 2014 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

80

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Kansas
      • Overland Park, Kansas, Stati Uniti, 66212
        • Vince and Associates Clinical Research, Inc.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 55 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Maschio

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: EB-1020 400 mg
EB-1020 400 mg, administered as four 100-mg IR capsules and 4 matching placebo capsules
Droga: EB-1020 400 mg
4 x EB-1020 100-mg capsules, and 4 matching placebo capsules
Sperimentale: EB-1020 800 mg
EB-1020 800 mg, administered as eight 100-mg IR capsules
Droga: EB-1020 800 mg
8 x EB-1020 100-mg capsules
Comparatore attivo: lisdexamfetamine 150 mg
lisdexamfetamine 150 mg, administered as 3 capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 matching placebo capsules
Droga: lisdexamfetamine 150 mg
3 x capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 x matching placebo capsules
Comparatore attivo: d-amphetamine 40 mg
d-amphetamine 40 mg, administered as 4 capsules, each containing two 5-mg d-amphetamine tablets and 4 matching placebo capsules
Droga: d-amphetamine 40 mg
4 x capsules, each containing 2 d-amphetamine 5-mg tablets, and 4 x matching placebo capsules
Comparatore placebo: Placebo
Placebo, administered as 8 matching placebo capsules
Droga: Placebo
8 x matching placebo capsules

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Maximum effect (Emax) on Drug Liking visual analog scale (VAS)
Lasso di tempo: 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).
within 24 hours post-dose

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Drug Liking VAS (minimum effect [Emin] and time-averaged area under the effect curve to 12 hours after study drug administration [TA_AUE])
Lasso di tempo: 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).
within 24 hours post-dose
Overall Drug Liking VAS (Emax/Emin)
Lasso di tempo: within 24 hours post-dose
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").
within 24 hours post-dose
Take Drug Again VAS (Emax)
Lasso di tempo: within 24 hours post-dose
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").
within 24 hours post-dose
High VAS (Emax and TA_AUE)
Lasso di tempo: within 24 hours post-dose
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).
within 24 hours post-dose
Good Effects VAS (Emax and TA_AUE)
Lasso di tempo: within 24 hours post-dose
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).
within 24 hours post-dose
Bad Effects VAS (Emax and TA_AUE)
Lasso di tempo: within 24 hours post-dose
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).
within 24 hours post-dose
Nausea VAS (Emax and TA_AUE)
Lasso di tempo: within 24 hours post-dose
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).
within 24 hours post-dose
ARCI-A scale (Emax and TA_AUE)
Lasso di tempo: within 24 hours post-dose
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.
within 24 hours post-dose
ARCI-BG scale (Emax and TA_AUE)
Lasso di tempo: within 24 hours post-dose
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.
within 24 hours post-dose
Alertness/Drowsiness VAS (Emax and TA_AUE)
Lasso di tempo: within 24 hours post-dose
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).
within 24 hours post-dose
Agitation/Relaxation VAS (Emax and TA_AUE)
Lasso di tempo: within 24 hours post-dose
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).
within 24 hours post-dose
Any Effects VAS (Emax and TA_AUE)
Lasso di tempo: within 24 hours post-dose
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).
within 24 hours post-dose
Drug Similarity VAS (score at 12 hours after study drug administration)
Lasso di tempo: within 24 hours post-dose
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.
within 24 hours post-dose
Safety and tolerability of EB-1020 as assessed by AEs
Lasso di tempo: Up to 6 weeks
Up to 6 weeks
Safety and tolerability of EB-1020 by laboratory assessments
Lasso di tempo: Up to 6 weeks
Up to 6 weeks
Safety and tolerability of EB-1020 as assessed by 12-lead ECGs
Lasso di tempo: Up to 6 weeks
Up to 6 weeks
Safety and tolerability of EB-1020 as assessed by vital signs
Lasso di tempo: Up to 6 weeks
Up to 6 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Neurovance, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2014

Completamento primario (Effettivo)

1 luglio 2014

Completamento dello studio (Effettivo)

1 luglio 2014

Date di iscrizione allo studio

Primo inviato

16 maggio 2014

Primo inviato che soddisfa i criteri di controllo qualità

19 maggio 2014

Primo Inserito (Stima)

22 maggio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

15 agosto 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 agosto 2014

Ultimo verificato

1 agosto 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EB-1020 IR-103

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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