Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users

NCT05319756 | Completed Phase 4 Results FDA Drug

• 1 other identifier: A9451180
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, double-blind, double-dummy, placebo- and active-controlled, 6 treatment, 6-period crossover single-dose, Williams square design study in healthy male and/or female adult, non-drug-dependent recreational opioid users.

Conditions

Abuse Potential

Keywords

Neurontin; Oxycodone; Abuse Liability; Gabapentin

Outcome Measures

Primary Outcomes (1)

• Bipolar Visual Analog Scale (VAS) for "Drug Liking" Maximum Effect (Emax).

  Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question ("at this moment, my liking this drug is") is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = "Strong Disliking", 50 mm = "Neither Like nor Dislike", and 100 mm = "Strong Liking"

  up to 48 hours after treatments

Secondary Outcomes (25)

• Bipolar VAS for "Drug Liking" - Time to Maximum Effect (TEmax)

  up to 48 hours after treatments

• Bipolar VAS for "Drug Liking": Area Under the Effect Curve From Time 0 to the Last Available Data (AUEClast)

  Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

• Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 1 Hour (AUEC1)

  Up to 1 hour post-dose (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, and 1 hour)

• Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 2 Hours (AUEC2)

  Up to 2 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, and 2 hours)

• Bipolar VAS for "Drug Liking": Area Under the Effect Curve to 3 Hours (AUEC3)

  up to 3 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, and 3 hours)

Study Arms (6)

gabapentin 600 mg single dose

EXPERIMENTAL

Drug: gabapentin 600 mg

gabapentin 1200 mg single dose

EXPERIMENTAL

Drug: gabapentin 1200 mg

gabapentin 600 mg and oxycodone HCl 20 mg

EXPERIMENTAL

Drug: gabapentin 600 mg and oxycodone HCl 20 mg

gabapentin 1200 mg and oxycodone HCl 20 mg

EXPERIMENTAL

Drug: gabapentin 1200 mg and oxycodone HCl 20 mg

oxycodone HCl 20 mg single dose

ACTIVE COMPARATOR

Drug: oxycodone HCl 20 mg

placebo single dose

PLACEBO COMPARATOR

Drug: placebo

Interventions

gabapentin 600 mg DRUG

Participants will receive a single oral dose of gabapentin 600 mg and a placebo that looks like oxycodone HCl

gabapentin 600 mg single dose

gabapentin 1200 mg DRUG

Participants will receive a single oral dose of gabapentin 1200 mg and a placebo that looks like oxycodone HCl

gabapentin 1200 mg single dose

gabapentin 600 mg and oxycodone HCl 20 mg DRUG

Participants will receive a single oral dose of gabapentin 600 mg and oxycodone HCl 20 mg

gabapentin 600 mg and oxycodone HCl 20 mg

gabapentin 1200 mg and oxycodone HCl 20 mg DRUG

Participants will receive a single oral dose of gabapentin 1200 mg and oxycodone HCl 20 mg

gabapentin 1200 mg and oxycodone HCl 20 mg

oxycodone HCl 20 mg DRUG

Participants will receive a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin

oxycodone HCl 20 mg single dose

placebo DRUG

Participants will receive a single oral dose of a placebo that looks like gabapentin and a placebo that looks like oxycodone HCl

placebo single dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants must be 18 to 55 years of age, inclusive, at the time of screening. Participants must meet reproductive criteria as outlined in the protocol.
• Male and female participants who are overtly healthy. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, vital signs, 12-lead ECG, and/or clinical laboratory tests.
• Participants must have drug abuse experience with opioids; ie, must have used opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions within the last year and at least once in the 8 weeks before the Screening Visit (Visit 1).
• Participants must satisfactorily complete both the Naloxone Challenge and the Drug Discrimination.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Body mass index (BMI) of 17.5 to 34 kg/m2, inclusive; and a total body weight ≥50 kg (110 lb).
• Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

You may not qualify if:

• Current or past diagnosis of any type of drug dependence within the past year. Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine) will be assessed by the Investigator using the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria performed at Screening. Current drug use will be allowed if the candidate can produce a negative urine sample and are free of any signs/symptoms of withdrawal. The candidate will be informed if they have a positive breathalyzer test.
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy) excluding cholecystectomy within 1 year prior to study.
• Abnormal baseline EtCO2 \<35mm Hg or \>45 mm Hg.
• Clinical or laboratory evidence of active hepatitis A infection or a history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C, and/or positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb).
• Participants with active suicidal ideation or suicidal behavior within 5 years prior to Screening as determined through the use of the Columbia Suicide Severity Rating Scale (C-SSRS) or active ideation identified at Screening or on Day 0.
• Participants with any history of sleep apnea, myasthenia gravis or glaucoma.
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product. (Refer to Section 6.5 for additional details).
• Herbal supplements, herbal medications and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of study medication.
• Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives (whichever is longer) preceding the first dose of investigational product used in this study.
• Positive urine drug screen (UDS) for substances of abuse at each admission in Qualification and Treatment Phase, excluding tetrahydrocannabinol (THC). If a participant presents with a positive UDS excluding THC at any admission or any visit, the investigator, at his/her discretion, may reschedule a repeat of UDS until the UDS is negative, excluding THC, before the participate is permitted to participate in any phase of the study.
• Unable to abstain from using THC during the Qualification and Treatment Phase of the study.
• Has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorders (excluding nicotine and caffeine).
• Has a positive alcohol breathalyzer or urine test at each admission to the study center during Qualification and Treatment Phases. Positive results may be repeated and/or participants re scheduled at the Investigator's discretions.

Sponsors & Collaborators

• Viatris Specialty LLC: lead

Study Sites (1)

Hassman Research Institute

Marlton, New Jersey, 080503, United States

Location

MeSH Terms

Interventions

Gabapentin; Oxycodone

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dik WH Ng
• Organization: Viatris

dik.ng@viatris.com

+44 (0)1304 626895

Study Officials

• Dik WH NG, PhD

  Viatris Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 8, 2022
• Study Start: April 30, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)