NCT04315181

Prescription Medication Interactions

Prescription Medications: Pharmacodynamics and Interaction Effects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Sharon Walsh · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the effects of doses of opioid/placebo and doses of sedative/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

Detailed description

Gabapentin and oxycodone are commonly used in combination for the treatment of chronic pain. Gabapentin is now widely misused/abused with studies indicating that gabapentin abuse is especially common among individuals with opioid misuse. The nature of gabapentin's abuse-related effects have been described in case reports and online as sedative-like and opioid-like, with descriptive reports including sedation, euphoria, talkativeness and increased energy. Despite their widespread co-administration both for licit and illicit purposes, no controlled psychopharmacological studies to our knowledge have directly examined the effects of oxycodone (or another opioid agonist) and gabapentin in combination. This study's objective is to characterize the subjective effect profile of gabapentin, examine the interaction between gabapentin and oxycodone, and assess the acute analgesic response to gabapentin and oxycodone, alone and in combination, across a range of doses for each drug.

Conditions

• Opioid Use
• Sedative Use

Interventions

Type	Name	Description
DRUG	Opioid Agonist	Abuse liability evaluation.
DRUG	Sedatives	Abuse liability evaluation.

Timeline

• Start date: 2019-03-25
• Primary completion: 2023-05-06
• Completion: 2023-05-06
• First posted: 2020-03-19
• Last updated: 2025-10-20
• Results posted: 2024-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study