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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Recreational CNS Depressant Use

Treatments: Drug: AZD7325; Drug: Placebo; Drug: Lorazepam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902772

D1140C00008

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 months to 55 years old

Volunteers: No 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

Trial design

100 participants in 7 patient groups, including a placebo group

A

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

B

Active Comparator group

Description:

Lorazepam

Treatment:

Drug: Lorazepam

C

Active Comparator group

Description:

Lorazepam

Treatment:

Drug: Lorazepam

D

Active Comparator group

Description:

Lorazepam

Treatment:

Drug: Lorazepam

E

Experimental group

Description:

AZD7325

Treatment:

Drug: AZD7325

F

Experimental group

Description:

AZD7325

Treatment:

Drug: AZD7325

G

Experimental group

Description:

AZD7325

Treatment:

Drug: AZD7325