Clinical trial NCT04315181: Prescription Medication Interactions
Official title: Prescription Medications: Pharmacodynamics and Interaction Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid Use
Sedative Use
Keywords: opioid
sedative
opiate
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-03-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Healthy adults, ages 18-55
* Current non-medical use of opioids and sedatives

Exclusion Criteria:

* Physical dependence on opioids, alcohol, or benzodiazepines/sedatives/hypnotics
* Seeking treatment for drug use
* Significant medical problems

Primary outcomes:
measure: Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking
timeFrame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Secondary outcomes:
measure: Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect
timeFrame: This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
measure: Change in Respiration Rate
timeFrame: Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
measure: Change in End-tidal Carbon Dioxide (EtCO2)
timeFrame: EtCO2 recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
measure: Change in Oxygen Saturation
timeFrame: Oxygen saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Center on Drug and Alcohol Research
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Sharon L Walsh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: