Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to examine the abuse potential of AZD7325. |
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Condition | Recreational CNS Depressant Use |
Intervention | Drug: Lorazepam Drug: AZD7325 Drug: Placebo |
Phase | Phase 1 |
Sponsor | AstraZeneca |
Responsible Party | AstraZeneca |
ClinicalTrials.gov Identifier | NCT00902772 |
First Received | May 12, 2009 |
Last Updated | September 22, 2009 |
Last verified | September 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | May 12, 2009 |
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Last Updated Date | September 22, 2009 |
Start Date | May 2009 |
Estimated Primary Completion Date | September 2009 |
Current Primary Outcome Measures | Visual Analog Scales [Time Frame: Daily during Visit 2 through 9] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Columbia Suicide-Severity Rating Scale [Time Frame: Prior to each treatment period] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
Brief Title | Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users |
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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 |
Brief Summary | The purpose of this study is to examine the abuse potential of AZD7325. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator) |
Condition | Recreational CNS Depressant Use |
Intervention | Drug: Lorazepam mg, oral dose Drug: AZD7325 mg, oral dose Drug: Placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 100 |
Estimated Completion Date | September 2009 |
Estimated Primary Completion Date | Not Provided |
Eligibility 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 |
Gender | Both |
Ages | 18 Months |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Canada |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00902772 |
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Other Study ID Numbers | D1140C00008 |
Has Data Monitoring Committee | No |
Information Provided By | AstraZeneca |
Study Sponsor | AstraZeneca |
Collaborators | Not Provided |
Investigators | Principal Investigator: Myroslava K Romach, MD Kendle Early Stage - Toronto |
Verification Date | September 2009 |
Locations[ + expand ][ + ]
Research Site | Toronto, Ontario, Canada |
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