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

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vallon Pharmaceuticals, Inc.
• Treatments: Amphetamine; Dextroamphetamine

Criteria

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)