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Abuse Potential

A Study to Determine the Abuse Potential of Tozadenant Relative to D-Amphetamine and Placebo When Administered Orally in Healthy, Non-Dependent, Recreational Polydrug Users

Sponsored by Biotie Therapies Inc.

About this trial

Last updated 7 years ago

Study ID

TOZ-CL09

Status

Terminated

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
18 to 55 Years
All
All

Trial Timing

Ended 8 years ago

What is this trial about?

This will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 6-way crossover study to determine the abuse potential of tozadenant relative to d-amphetamine and placebo, when administered orally in healthy non-dependent, recreational polydrug users with stimulant experience, under fed conditions. Each subject will participate in a medical Screening visit, a 4-day (3-night) qualification (drug discrimination) visit, six 3-day (2-night) treatment periods, and a follow-up visit.

What are the participation requirements?

Yes

Inclusion Criteria

- Healthy male or female subjects 18 to 55 years of age, inclusive.

- Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 and a minimum weight of at least 50.0 kg

- Current recreational polydrug users who self-report to:

- Have used stimulants (e.g., amphetamines, cocaine, methylphenidate) for non-therapeutic purposes (i.e., for psychoactive effects) at least 10 times in the past year and at least 1 time in the 8 weeks before Screening.
- Have at least 10 lifetime uses of drugs (e.g., opioids, sedatives) from at least 1 other class other than alcohol.

- Agree to use an approved method of contraception

- Be willing and able to abide by all study requirements and restrictions

- Additional criteria may apply

No

Exclusion Criteria

- Substance or alcohol dependence within the past 2 years,

- Clinically significant medical history or illness

- Female subjects who have a positive pregnancy test, are currently pregnant or lactating, or who are planning to become pregnant within 30 days of last study drug administration.

- Donation or loss of more than 500 mL whole blood within 30 days preceding the Screening visit.

- Additional criteria may apply.

Locations

Location

Status