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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00902772

Enrollment

100

Registered

2009-05-15

Start date

2009-05-31

Completion date

2009-09-30

Last updated

2009-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recreational CNS Depressant Use

Keywords

Recreational CNS depressant, Abuse liability, Abuse potential, Healthy Recreational CNS Depressant Users

Brief summary

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

Interventions

DRUGLorazepam

mg, oral dose

DRUGAZD7325

mg, oral dose

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Months to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Visual Analog Scales	Daily during Visit 2 through 9

Secondary

Measure	Time frame
Columbia Suicide-Severity Rating Scale	Prior to each treatment period

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026