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A randomized, double-blind, double-dummy, active and placebo controlled five-way crossover study Human Abuse Potential study of oral nalbuphine ER in recreational drug users (HAP study)

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A randomized, double-blind, double-dummy, active and placebo controlled five-way crossover study Human Abuse Potential study of oral nalbuphine ER in recreational drug users (HAP study)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 09 Dec 2024

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At a glance

  • Drugs Nalbuphine (Primary) ; Butorphanol
  • Indications Cough; Drug-induced dyskinesia; Prurigo nodularis; Pruritus
  • Focus Adverse reactions
  • Acronyms HAP study
  • Sponsors Trevi Therapeutics

    • Most Recent Events

    • 03 Dec 2024 According to a Trevi Therapeutics media release, the results of this HAP study will be included in the 8-factor analysis of the abuse potential of nalbuphine for nalbuphine ER that would be submitted as part of any NDA submission to inform scheduling considerations.
    • 03 Dec 2024 Results presented in the Trevi Therapeutics Media Release
    • 03 Dec 2024 According to a Trevi Therapeutics media release, the company will host a conference call and webcast on 3 Dec 2024 at 5:00 p.m. ET, to review the topline results.

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