Abuse Potential of HORIZANT With and Without Oxycodone in Healthy, Nondependent Recreational Opioid Users
NCT06247488 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110
Last updated 2024-08-12
Summary
The purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate release capsules taken alone and in combination with oxycodone in healthy adult, non-dependent, recreational opioid users.
Conditions
- Abuse Potential
Interventions
- DRUG
-
Participant will receive oral dose of placebo.
- DRUG
-
Oxycodone 20 mg
Participant will receive oral dose of oxycodone 20 mg.
- DRUG
-
GE-IR 200 mg
Participant will receive oral dose of GE-IR 200 mg and oxycodone 20 mg.
- DRUG
-
GE-IR 450 mg
Participant will receive oral dose of GE-IR 450 mg and oxycodone 20 mg.
Sponsors & Collaborators
-
Arbor Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-01-31
- Primary Completion
- 2023-04-25
- Completion
- 2023-04-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy
NCT00735124 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy
NCT00954187 ·Status: TERMINATED ·Phase: NA
-
Evaluation of Individual Bioequivalence of Gabasandoz® Relative to Neurontin® in Healthy Volunteers
NCT01821235 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of Early Use of Oxycodone During the Acute Phase of Herpes Zoster on Preventing Postherpetic Neuralgia
NCT03120962 ·Status: UNKNOWN ·Phase: NA
-
Does Postoperative Gabapentin Reduce Pain, Opioid Consumption and Anxiety and Have a Positive Effect on Health Related Quality of Life After Radical Prostatectomy?
NCT00982800 ·Status: COMPLETED ·Phase: PHASE4
-
Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management
NCT02703259 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Perioperative Gabapentin on Postoperative Opioid Requirements
NCT05494385 ·Status: COMPLETED ·Phase: PHASE4
-
A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS
NCT02633657 ·Status: WITHDRAWN ·Phase: PHASE1
-
Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores
NCT02840240 ·Status: COMPLETED ·Phase: NA
-
Prevalence of Gabapentinoids and Opioids in Geriatric Falls Patients
NCT06613802 ·Status: COMPLETED
-
The Effect of Oral Gabapentin on Emergence Agitation and Delirium in Adult Patients After Nasal Surgery.
NCT06887998 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
A Study Of The Efficacy Of Gabapentin In Neuropathic Pain Patients As Measured By Quantitative Sensory Testing
NCT00674687 ·Status: COMPLETED ·Phase: NA
-
Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Cancer
NCT03269344 ·Status: COMPLETED ·Phase: PHASE3
-
Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome
NCT02117076 ·Status: TERMINATED ·Phase: PHASE4
-
Drug Use Investigation Of Gabapentin
NCT00567268 ·Status: COMPLETED
-
Cancer in Patients With Gabapentin (GPRD)
NCT01236053 ·Status: COMPLETED
-
Preanalgesic Effect of Gabapentin in Total Knee Repair
NCT00279487 ·Status: COMPLETED ·Phase: NA
-
Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain?
NCT00934193 ·Status: WITHDRAWN ·Phase: PHASE3
-
The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy
NCT01122004 ·Status: UNKNOWN ·Phase: PHASE1
-
A Clinical Study in Subjects With Neuropathic Pain From PHN Who Have Had an Inadequate Response to Gabapentin Treatment
NCT00617461 ·Status: COMPLETED ·Phase: PHASE2
-
Drug Drug Interaction Study With Gabapentin Enacarbil and Morphine
NCT01476124 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
NCT00667108 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Pharmacodynamic Interaction Between Gabapentin and Ethanol in Healthy Subjects
NCT00666796 ·Status: COMPLETED ·Phase: PHASE4
-
Gabapentin & Ketamine for Prevention/Treatment of Acute/Chronic Pain in Locally Advanced Head and Neck Cancer
NCT05156060 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Pregabalin Versus Gabapentin Opioid Sparing Effect in Discectomy
NCT05539924 ·Status: UNKNOWN ·Phase: PHASE3