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Prescription Medication Interactions

NCT ID: NCT04315181

Last Updated: 2025-10-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2023-05-06

Brief Summary

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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.

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Detailed Description

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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

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Opioid Use Sedative Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
This is a randomized, double-blind, double-dummy, placebo- controlled design

Study Groups

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Placebo / Placebo

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.

Group Type PLACEBO_COMPARATOR

Opioid Agonist

Intervention Type DRUG

Abuse liability evaluation.

Sedatives

Intervention Type DRUG

Abuse liability evaluation.

Placebo / Oxycodone 20mg

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.

Group Type EXPERIMENTAL

Opioid Agonist

Intervention Type DRUG

Abuse liability evaluation.

Sedatives

Intervention Type DRUG

Abuse liability evaluation.

Placebo / Oxycodone 40mg

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.

Group Type EXPERIMENTAL

Opioid Agonist

Intervention Type DRUG

Abuse liability evaluation.

Sedatives

Intervention Type DRUG

Abuse liability evaluation.

Gabapentin 600mg / Placebo

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.

Group Type EXPERIMENTAL

Opioid Agonist

Intervention Type DRUG

Abuse liability evaluation.

Sedatives

Intervention Type DRUG

Abuse liability evaluation.

Gabapentin 1200mg / Placebo

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.

Group Type EXPERIMENTAL

Opioid Agonist

Intervention Type DRUG

Abuse liability evaluation.

Sedatives

Intervention Type DRUG

Abuse liability evaluation.

Gabapentin 600mg / Oxycodone 20mg

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.

Group Type EXPERIMENTAL

Opioid Agonist

Intervention Type DRUG

Abuse liability evaluation.

Sedatives

Intervention Type DRUG

Abuse liability evaluation.

Gabapentin 1200mg / Oxycodone 20mg

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.

Group Type EXPERIMENTAL

Opioid Agonist

Intervention Type DRUG

Abuse liability evaluation.

Sedatives

Intervention Type DRUG

Abuse liability evaluation.

Gabapentin 600mg / Oxycodone 40mg

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.

Group Type EXPERIMENTAL

Opioid Agonist

Intervention Type DRUG

Abuse liability evaluation.

Sedatives

Intervention Type DRUG

Abuse liability evaluation.

Gabapentin 1200mg / Oxycodone 40mg

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.

Group Type EXPERIMENTAL

Opioid Agonist

Intervention Type DRUG

Abuse liability evaluation.

Sedatives

Intervention Type DRUG

Abuse liability evaluation.

Interventions

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Opioid Agonist

Abuse liability evaluation.

Intervention Type DRUG

Sedatives

Abuse liability evaluation.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Sharon Walsh

OTHER

Sponsor Role lead

Responsible Party

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Sharon Walsh

Director, Center on Drug and Alcohol Research

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sharon L Walsh, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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Center on Drug and Alcohol Research

Lexington, Kentucky, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01DA016718

Identifier Type: NIH

Identifier Source: secondary_id

View Link

46591

Identifier Type: -

Identifier Source: org_study_id

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