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Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recreational CNS Depressant Use

Intervention: Lorazepam (Drug); AZD7325 (Drug); Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Myroslava K Romach, MD, Principal Investigator, Affiliation: Kendle Early Stage - Toronto

Summary

The purpose of this study is to examine the abuse potential of AZD7325.

Clinical Details

Official title: A Single-Centre, Single-Dose, Double-Blind, Randomized, Placebo- and Active-Controlled Crossover Study to Evaluate the AbusePotential of AZD7325 in Healthy Recreational CNS Depressant Users

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Visual Analog Scales

Secondary outcome: Columbia Suicide-Severity Rating Scale

Eligibility

Minimum age: 18 Months. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Recreational CNS depressant use, defined as at least 10 lifetime occasions of

non-medical use of drugs with depressant/sedative properties and at least 1 non-medical use in the year prior to screening

- Body mass index (BMI) within the range of 19. 0 to 33. 0 kg/m2, inclusive, and a

minimum weight of 50. 0 kg at screening

- Willing and able to abide by all study requirements and restrictions

Exclusion Criteria:

- Unwillingness of inability to abstain from recreational drug use for the duration of

the study from screening until follow-up

- Positive breath alcohol test prior to dosing

- Clinically significant abnormalities on physical examination, medical history,

12-lead ECG, vital signs, or safety laboratories

Locations and Contacts

Research Site, Toronto, Ontario, Canada
Additional Information

Starting date: May 2009
Last updated: September 22, 2009

Page last updated: August 23, 2015

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