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

ADHD Clinical Trial

— SEAL  

Official title:

A Randomized, Double-Blind, Double-Dummy, Placebo-, Active-Controlled, 4 Period, 4 Way Crossover Study to Evaluate the Abuse Potential of Manipulated Abuse-Deterrent Dextroamphetamine Sulfate Immediate Release (ADAIR) Formulation Compared to Dextroamphetamine Sulfate Immediate Release When Administered Intranasally to Nondependent, Recreational Stimulant Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04647903
• Other study ID #: VAL-104
• Status: Completed
• Phase: Phase 1
• Start date: October 5, 2020
• Est. completion date: December 17, 2021

Study information

• Verified date: December 2021
• Source: Vallon Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study will consist of an outpatient Screening Visit, an in clinic Qualification Phase, an in-clinic Treatment Phase, and an outpatient Follow-Up visit.

Description:

VAL-104 is a phase 1, randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study objectives include assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of manipulated ADAIR 30mg when compared to crushed d-amphetamine sulfate and placebo. The primary PD endpoint is mean maximum drug liking (Emax) on a bipolar 100mm visual analog scale. A total of 64 subjects demonstrating a confirmed positive response to stimulants will enter the treatment phase. Safety will be assess via adverse events, vital signs, ECGs, clinical laboratory tests and Columbia Suicide Severity Rating Scale (C-SSRS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male or female volunteers, 18 to 55 years of age inclusive
• Recreational drug abuse experience (>/= 10 times lifetime abuse of a CNS stimulant, >/= 1 abuse of CNS stimulant in the previous 3 months)
• Prior intranasal recreational drug abuse experience
• Body mass index (BMI) 18 to 33 kg/m2 inclusive

Exclusion Criteria:

• History of any significant disease or disorder
• History or current diagnosis of substance dependence (excluding caffeine and nicotine)
• Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
• Positive for hepatitis B, hepatitis C or HIV infection
• Pregnant or lactating women
• Participation in an investigational drug or device study within the last 30 days prior to Day 1 of the study
• Confirmed positive drug screening
• Positive alcohol breath test at screening / any Day -1
• Heavy smoker (> 20 cigarettes, > 8 pipefuls or > 8 cigars per day)

Related Conditions & MeSH terms

• ADHD
• Narcolepsy

Intervention

Drug:
• ADAIR 10 mg IR tablets
manipulated ADAIR 3x10mg
• d-amphetamine sulfate
crushed d-amphetamine sulfate 3x10mg
• Placebo
placebo for oral and intranasal administration

Locations

Country	Name	City	State
United States	Vallon Investigational Site	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Vallon Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Liking Emax Visual Analog Scale (VAS)	Peak effect for drug liking based on bipolar VAS from 0-100 scale	Up to 24 hours post-dose
Secondary	Take Drug Again Emax VAS	Peak effect for take drug again based on bipolar VAS from 0-100 scale	Up to 24 hours post dose
Secondary	Overall Drug Liking Emax VAS	Peak effect for overall drug liking based on bipolar VAS from 0-100 scale	Up to 24 hours post dose
Secondary	Plasma concentrations (PK parameters)	plasma concentrations of ADAIR and dextroamphetamine sulfate	Up to 36 hours post dose
Secondary	Safety (adverse events)	Incidence of adverse events	Day 1 to Day 18