A Single-dose, Double-blind, Double-dummy, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of Dronabinol Oral Solution in Recreational Cannabinoid Users

Trial Profile

A Single-dose, Double-blind, Double-dummy, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of Dronabinol Oral Solution in Recreational Cannabinoid Users

Completed
Phase of Trial: Phase I

Latest Information Update: 02 Jun 2015

At a glance

  • Drugs Dronabinol (Primary)
  • Indications Anorexia; Chemotherapy-induced nausea and vomiting
  • Focus Adverse reactions
  • Sponsors INSYS Therapeutics, Inc
  • Most Recent Events

    • 02 Jun 2015 According to an Insys Therapeutics media release, a New Drug Application has been re-submitted to the US FDA. Earlier a 'Refusal to File' letter was received in October 2014 for previously submitted NDA due to inadequate or incomplete pediatric study plan.
    • 12 May 2014 Status changed from not yet recruiting to completed as reported by ClinicalTrials.gov
    • 27 Mar 2014 New trial record
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