Prescription Medication Interactions

NCT04315181 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 46591R01DA016718
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Sedative Use

Keywords

opioid; sedative; opiate

Outcome Measures

Primary Outcomes (1)

• Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking

  Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Raw data transformed to peak scores. Higher scores indicate greater drug effects.

  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 (4)

• Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect

  This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).

• Change in Respiration Rate

  Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).

• Change in End-tidal Carbon Dioxide (EtCO2)

  EtCO2 recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).

• Change in Oxygen Saturation

  Oxygen saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).

Study Arms (9)

Placebo / Placebo

PLACEBO COMPARATOR

Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.

Drug: Opioid Agonist; Drug: Sedatives

Placebo / Oxycodone 20mg

EXPERIMENTAL

Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.

Drug: Opioid Agonist; Drug: Sedatives

Placebo / Oxycodone 40mg

EXPERIMENTAL

Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.

Drug: Opioid Agonist; Drug: Sedatives

Gabapentin 600mg / Placebo

EXPERIMENTAL

Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.

Drug: Opioid Agonist; Drug: Sedatives

Gabapentin 1200mg / Placebo

EXPERIMENTAL

Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.

Drug: Opioid Agonist; Drug: Sedatives

Gabapentin 600mg / Oxycodone 20mg

EXPERIMENTAL

Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.

Drug: Opioid Agonist; Drug: Sedatives

Gabapentin 1200mg / Oxycodone 20mg

EXPERIMENTAL

Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.

Drug: Opioid Agonist; Drug: Sedatives

Gabapentin 600mg / Oxycodone 40mg

EXPERIMENTAL

Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.

Drug: Opioid Agonist; Drug: Sedatives

Gabapentin 1200mg / Oxycodone 40mg

EXPERIMENTAL

Participants will receive non-therapeutic experimental doses of gabapentin (600 and 1200 mg, p.o.), alone and in combination with oxycodone (20 and 40 mg, p.o.). The experimental sessions are designed to capture the time-action curves for the test drugs (Tmax for gabapentin ≈ 2.5 hr; oxycodone ≈ 1.5 hr). Therefore, oxycodone will be administered 1 hr after gabapentin to align peak responses.

Drug: Opioid Agonist; Drug: Sedatives

Interventions

Opioid Agonist DRUG

Abuse liability evaluation.

Gabapentin 1200mg / Oxycodone 20mg; Gabapentin 1200mg / Oxycodone 40mg; Gabapentin 1200mg / Placebo; Gabapentin 600mg / Oxycodone 20mg; Gabapentin 600mg / Oxycodone 40mg; Gabapentin 600mg / Placebo; Placebo / Oxycodone 20mg; Placebo / Oxycodone 40mg; Placebo / Placebo

Sedatives DRUG

Abuse liability evaluation.

Gabapentin 1200mg / Oxycodone 20mg; Gabapentin 1200mg / Oxycodone 40mg; Gabapentin 1200mg / Placebo; Gabapentin 600mg / Oxycodone 20mg; Gabapentin 600mg / Oxycodone 40mg; Gabapentin 600mg / Placebo; Placebo / Oxycodone 20mg; Placebo / Oxycodone 40mg; Placebo / Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sharon Walsh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center on Drug and Alcohol Research

Lexington, Kentucky, 40508, United States

Location

MeSH Terms

Interventions

Analgesics, Opioid; Hypnotics and Sedatives

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Director for the Center on Drug and Alcohol Research
• Organization: University of Kentucky

Sharon.Walsh@uky.edu

859-257-6485

Study Officials

• Sharon L Walsh, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a randomized, double-blind, double-dummy, placebo- controlled design
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Center on Drug and Alcohol Research

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: March 25, 2019
• Primary Completion: May 6, 2023
• Study Completion: May 6, 2023
• Last Updated: October 20, 2025
• Results First Posted: June 27, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)