drugset / Trial / NCT04647903

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

NCT04647903

Phase 1 Completed 55 enrolled Vallon Pharmaceuticals, Inc.
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2020-10-05
Primary completion
2021-12-17
Completion
2021-12-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dextroamphetamine Small molecule 30 mg Oral