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

NCT04647903 PHASE1 COMPLETED

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.

Details

Lead sponsor	Vallon Pharmaceuticals, Inc.
Phase	PHASE1
Status	COMPLETED
Enrolment	55
Start date	Mon Oct 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Dec 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• ADHD
• Narcolepsy

Interventions

• ADAIR 10 mg IR tablets
• d-amphetamine sulfate
• Placebo

Countries

United States