Pilot Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Abuse Liability of an Abuse-Deterrent Immediate-Release Formulation (ADAIR)

ADHD Clinical Trial

Official title: A Pilot, Randomized, Double-Blind, Active-Controlled, 2-Treatment, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Abuse Liability of Dextroamphetamine Sulfate From an Abuse-Deterrent Immediate-Release Formulation (ADAIR)

Status Completed

Clinical Trial Summary

This is a pilot randomized, double-blind, active-controlled, 2-treatment, crossover study to evaluate the PK, user experience and abuse liability of manipulated ADAIR compared to a manipulated commercially-available d-amphetamine sulfate IR formulation administered intranasally in non-dependent recreational stimulant users. The study is comprised of 4 phases: Screening, Qualification, Treatment, and Follow-up/Early Termination.

Clinical Trial Description

VAL-103 is a phase 1, pilot, randomized, double-blind, active-controlled, 2-treatment crossover study. The study objectives include assessing the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of manipulated ADAIR 30 mg compared to crushed d-amphetamine sulfate IR 30 mg (DEX) administered IN in non-dependent recreational stimulant users. The primary PD endpoint is mean maximum drug liking (Emax) on a bipolar 100mm visual analog scale.

A total of 16 qualified subjects demonstrating a confirmed positive response to stimulants will enter the treatment phase. Safety will be assessed via adverse events, vital signs, ECGs, clinical laboratory tests, and Columbia Suicide Severity Rating Scale (C-SSRS). ;

Related Conditions & MeSH terms

• ADHD
• Narcolepsy

• NCT number: NCT04232644
• Study type: Interventional
• Source: Vallon Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 1
• Start date: May 27, 2019
• Completion date: July 17, 2019