NCT03765346

A Comparison of How Likely it is That Different Tablets of Oxycodone Will be Broken up and Snorted by Adults Who Sometimes Take Drugs for Pleasure

A Single-site, Randomized, Double-blind, Double-dummy, Active-comparator, Placebo-controlled, 3-way Crossover Trial in Adult Non-dependent Recreational Opioid Users to Compare the Intranasal Abuse Potential of Immediate Release Abuse-deterrent and Standard Formulations of Oxycodone

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The trial comprises an Enrollment Visit, a Qualification Phase, a Treatment Phase (including 3 treatment periods), a Final Examination, and a Follow-up Phone Call. The Qualification Phase includes a naloxone challenge test (to verify that participants are not opioid-dependent) and a drug discrimination test (to determine whether or not participants are able to distinguish intranasally administered active drug from placebo). Participants will be randomized to receive a single intranasal dose each of oxycodone active pharmaceutical ingredient (API) and matching placebo in a double-blind manner. The total mass of each single dose will be 30 milligrams. Participants who successfully complete the Qualification Phase are eligible to be included in the Treatment Phase. During the Treatment Phase, participants will receive test product, comparator, and placebo following a randomized, double-blind, double-dummy, 3-way crossover design. Participants will receive a single intranasal dose of each of the treatments (combined doses of investigational medicinal product {IMP}) on Day 1, Day 4, and Day 7 of the Treatment Phase. A single dose of a treatment is defined as insufflation of single doses of the 2 applicable IMPs in quick succession. The 2 applicable IMPs must be insufflated in the following pre-defined order. Oxycodone API or placebo to match oxycodone API must always be insufflated first. Oxycodone immediate release (IR) abuse-deterrent formulation (ADF) or placebo to match oxycodone IR ADF must always be insufflated second. The total mass of each single dose of treatment will be 570 milligrams.

Conditions

• Substance Abuse

Interventions

Type	Name	Description
DRUG	Oxycodone IR ADF	Oxycodone IR ADF manipulated/crushed (mass of 540 mg, containing oxycodone hydrochloride 30 mg), in a standardized procedure.
DRUG	Oxycodone API powder	Oxycodone API powder (mass of 30 mg), containing oxycodone hydrochloride 30 mg.
DRUG	Placebo to match oxycodone API powder	Placebo to match oxycodone API powder (mass of 30 mg).
DRUG	Placebo to match manipulated oxycodone IR ADF.	Placebo to match oxycodone IR ADF, manipulated (mass of 540 mg).

Timeline

• Start date: 2018-07-24
• Primary completion: 2018-11-05
• Completion: 2018-11-05
• First posted: 2018-12-05
• Last updated: 2018-12-05

Locations

1 site across 1 country: Canada