Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience

NCT04570436 | Completed Phase 4 Results FDA Drug

• 1 other identifier: A9451181
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, double-blind, double-dummy, placebo- and active controlled, 5 treatment, 10 sequence, 5 period crossover single dose, Williams square design study in healthy adult, non drug dependent male and female participants with drug abuse experience with sedative drugs.

Conditions

Abuse Potential

Keywords

Neurontin; Diazepam; 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 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 72 hours after treatments

Secondary Outcomes (17)

• Bipolar VAS for "Drug Liking" (Time for Maximum Effect, Emax [TEmax])

  up to 72 hours after treatments

• Bipolar VAS for "Drug Liking" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])

  Up to 72 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, 48, and 72 hours)

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

  up to 72 hours after treatments

• Unipolar VAS for "High" (Time for Maximum Effect, Emax [TEmax])

  up to 72 hours after treatments

• Unipolar VAS for "High" (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])

  Up to 72 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, 48, and 72 hours)

Study Arms (5)

gabapentin 600 mg

EXPERIMENTAL

single dose

Drug: gabapentin 600 mg

diazepam 20 mg

ACTIVE COMPARATOR

single dose

Drug: diazepam 20 mg

placebo

PLACEBO COMPARATOR

single dose

Other: placebo

gabapentin 1200 mg

EXPERIMENTAL

single dose

Drug: gabapentin 1200 mg

gabapentin 1800 mg

EXPERIMENTAL

single dose

Drug: gabapentin 1800 mg

Interventions

gabapentin 600 mg DRUG

participants will receive an oral dose of gabapentin 600 mg

gabapentin 600 mg

gabapentin 1200 mg DRUG

participants will receive an oral dose of gabapentin 1200 mg

gabapentin 1200 mg

gabapentin 1800 mg DRUG

participants will receive an oral dose of gabapentin 1800 mg

gabapentin 1800 mg

diazepam 20 mg DRUG

participants will receive an oral dose of 20 mg dose of diazepam

diazepam 20 mg

placebo OTHER

participants will receive an oral dose of placebo

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants must be 18 to 65 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 electrocardiogram (ECG), and/or clinical laboratory tests.
• Participants must be recreational sedative users, defined as those reporting using a sedative agent (eg, barbiturates, benzodiazepines) for its intoxicating effects on at least 10 lifetime occasions and at least once in the 12 weeks before the Screening Visit (Visit 1), but who have no signs of dependence and are not seeking treatment for their sedative use.
• Participants must satisfactorily complete both the Naloxone Challenge and the Drug Discrimination phases.
• 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:

• Participants with 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.
• Participants are heavy smokers or users of other types of nicotine products (\>20 cigarettes equivalents per day)
• Participants are unable to abstain from smoking for at least 2 hours before and at least 8 hours after study drug administration.
• 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).
• Participants with any history of sleep apnea, myasthenia or glaucoma.
• Any condition possibly affecting drug absorption (eg, gastrectomy) excluding cholecystectomy within 1 year prior to study.
• 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 -1.
• 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 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 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 UDS until the UDS is negative, excluding THC, before the participant is permitted to participate in any phase of the study.
• Participants unable to abstain from using THC during the Qualification and Treatment Phases 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).

Sponsors & Collaborators

• Viatris Specialty LLC: lead

Study Sites (1)

Pharmaceutical Research Associates, Inc.

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

Gabapentin; Diazepam

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; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dik WH Ng
• Organization: Viatris

dik.ng@viatris.com

+44 (0)1304 626895

Publication Agreements

• PI is Sponsor Employee: No
• 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: September 24, 2020
• First Posted: September 30, 2020
• Study Start: March 29, 2021
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: July 24, 2024
• Results First Posted: December 6, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)