Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
- Conditions
- NarcolepsyADHD
- Interventions
- Registration Number
- NCT04647903
- Lead Sponsor
- Vallon Pharmaceuticals, Inc.
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oral Placebo + Intranasal crushed dextroamphetamine sulfate d-amphetamine sulfate Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg Oral Placebo + Intranasal crushed dextroamphetamine sulfate Placebo Oral Placebo + Intranasal crushed dextroamphetamine sulfate IR 30 mg Oral ADAIR + Intranasal Placebo Placebo Oral ADAIR 30 mg + Intranasal Placebo Oral Placebo + Intranasal manipulated ADAIR ADAIR 10 mg IR tablets Oral Placebo + Intranasal manipulated ADAIR 30 mg Oral Placebo + Intranasal Placebo Placebo Oral Placebo + Intranasal Placebo Oral Placebo + Intranasal manipulated ADAIR Placebo Oral Placebo + Intranasal manipulated ADAIR 30 mg
- Primary Outcome Measures
Name Time Method Drug Liking Emax Visual Analog Scale (VAS) Up to 24 hours post-dose Peak effect for drug liking based on bipolar VAS from 0-100 scale
- Secondary Outcome Measures
Name Time Method Take Drug Again Emax VAS Up to 24 hours post dose Peak effect for take drug again based on bipolar VAS from 0-100 scale
Plasma concentrations (PK parameters) Up to 36 hours post dose plasma concentrations of ADAIR and dextroamphetamine sulfate
Overall Drug Liking Emax VAS Up to 24 hours post dose Peak effect for overall drug liking based on bipolar VAS from 0-100 scale
Safety (adverse events) Day 1 to Day 18 Incidence of adverse events
Trial Locations
- Locations (1)
Vallon Investigational Site
🇺🇸Salt Lake City, Utah, United States