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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00902772
First received: May 12, 2009
Last updated: September 22, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Recreational CNS Depressant Use
 Drug: Lorazepam
Drug: AZD7325
Drug: Placebo
 Phase 1

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

Resource links provided by NLM:

Drug Information available for: Lorazepam
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Visual Analog Scales [ Time Frame: Daily during Visit 2 through 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Columbia Suicide-Severity Rating Scale [ Time Frame: Prior to each treatment period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2009
Study Completion Date: September 2009
Arms Assigned Interventions
Placebo Comparator: A
Placebo
 Drug: Placebo
Active Comparator: B
Lorazepam
 Drug: Lorazepam
mg, oral dose
Active Comparator: C
Lorazepam
 Drug: Lorazepam
mg, oral dose
Active Comparator: D
Lorazepam
 Drug: Lorazepam
mg, oral dose
Experimental: E
AZD7325
 Drug: AZD7325
mg, oral dose
Experimental: F
AZD7325
 Drug: AZD7325
mg, oral dose
Experimental: G
AZD7325
 Drug: AZD7325
mg, oral dose

  Eligibility

Ages Eligible for Study:   18 Months to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902772

Locations
Canada, Ontario
Research Site
Toronto, Ontario, Canada
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Myroslava K Romach, MD Kendle Early Stage - Toronto
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00902772     History of Changes
Other Study ID Numbers: D1140C00008
Study First Received: May 12, 2009
Last Updated: September 22, 2009
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Recreational CNS depressant
Abuse liability
Abuse potential
Healthy Recreational CNS Depressant Users

Additional relevant MeSH terms:
Central Nervous System Depressants
Lorazepam
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
 Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013