ADHD, Narcolepsy
Conditions
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).
Interventions
DRUGADAIR 10 mg IR tablets
manipulated ADAIR 3x10mg
DRUGd-amphetamine sulfate
crushed d-amphetamine sulfate 3x10mg
DRUGPlacebo
placebo for oral and intranasal administration
Sponsors
Vallon Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Plasma concentrations (PK parameters) | Up to 36 hours post dose | plasma concentrations of ADAIR and dextroamphetamine sulfate |
| Safety (adverse events) | Day 1 to Day 18 | Incidence of adverse events |
Countries
United States
Outcome results
None listed