Study Evaluating Abuse Potential of Lyrica® in Healthy Non-Drug Dependent Recreational Opioid Users

NCT05053126 | Completed Phase 4 Results FDA Drug

• 1 other identifier: A0081365
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 4 clinical study in healthy non-drug dependent recreational opioid users to assess the abuse potential of Lyrica when taken alone or in combination with oxycodone.

Conditions

Abuse Potential

Keywords

Lyrica; Pregabalin; Oxycodone; Opioid; Abuse liability

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 treatment

Secondary Outcomes (4)

• Unipolar VAS for "High" - Maximum Effect (Emax)

  up to 48 hours after treatment

• Bipolar VAS for "Take Drug Again"

  Up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)

• Bipolar VAS for "Overall Drug Liking"

  Up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)

• Unipolar VAS for "Any Drug Effect"

  up to 48 hours after treatment

Study Arms (6)

Lyrica 300 mg

EXPERIMENTAL

Single Dose

Drug: Pregabalin 300mg

Lyrica 450 mg

EXPERIMENTAL

Single Dose

Drug: pregabalin 450 mg

Lyrica 300mg with Oxycodone 20 mg

EXPERIMENTAL

Single Dose

Drug: Pregabalin 300 mg with oxycodone 20 mg

Lyrica 450 mg with Oxycodone 20 mg

EXPERIMENTAL

Single Dose

Drug: pregabalin 450 mg with oxycodone 20 mg

Oxycodone 20 mg

ACTIVE COMPARATOR

Single Dose

Drug: oxycodone 20 mg

Placebo

PLACEBO COMPARATOR

Single Dose

Drug: Placebo

Interventions

Pregabalin 300mg DRUG

Participant will receive an oral dose of pregabalin 300 mg

Lyrica 300 mg

pregabalin 450 mg DRUG

Participant will receive an oral dose of pregabalin 450 mg

Lyrica 450 mg

Pregabalin 300 mg with oxycodone 20 mg DRUG

Participant will receive an oral dose of pregabalin 300 mg and oxycodone 20 mg

Lyrica 300mg with Oxycodone 20 mg

pregabalin 450 mg with oxycodone 20 mg DRUG

Participant will receive an oral dose of pregabalin 450 mg and oxycodone 20 mg

Lyrica 450 mg with Oxycodone 20 mg

oxycodone 20 mg DRUG

Participant will receive an oral dose of oxycodone 20 mg

Oxycodone 20 mg

Placebo DRUG

Participant will receive an oral dose of placebo

Placebo

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. There must be no less than 20% female participants in the Treatment Phase.
• Male and female participants who are overtly healthy. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full 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, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD).

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-4 (DSM-4) 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 year 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.
• 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.
• Patients with: sleep apnea, myasthenia gravis and glaucoma.
• 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.
• Herbal supplements and herbal medications 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 the 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 participant 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 phase. 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, 08053, United States

Location

MeSH Terms

Interventions

Pregabalin; Oxycodone

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; 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

  Mylan Pharmaceutials

  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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 22, 2021
• Study Start: July 27, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• 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)