Recreational CNS Depressant UsePhase 1NCT00902772
Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users
A Phase 1 study testing Lorazepam and AZD7325 in people with Recreational CNS Depressant Use, run by AstraZeneca at 1 site in Canada.
Trial summary
The purpose of this study is to examine the abuse potential of AZD7325. Read more about this study
- Who is it for?
- Ages 18 months to 55 years
- Conditions the study is for
- Recreational CNS Depressant Use
- What is being tested?
- Lorazepam and AZD7325
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- May 2009to Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to examine the abuse potential of AZD7325.
- Conditions
- Recreational CNS Depressant Use
- Being tested
- Lorazepam, AZD7325, Placebo
- Keywords
- Recreational CNS depressant, Abuse liability, Abuse potential, Healthy Recreational CNS Depressant Users
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorazepamDrug
mg, oral dose
AZD7325Drug
mg, oral dose
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo Receives: Drug: Placebo |
| B | Active comparator | Lorazepam Receives: Drug: Lorazepam |
| C | Active comparator | Lorazepam Receives: Drug: Lorazepam |
| D | Active comparator | Lorazepam Receives: Drug: Lorazepam |
| E | Experimental | AZD7325 Receives: Drug: AZD7325 |
| F | Experimental | AZD7325 Receives: Drug: AZD7325 |
| G | Experimental | AZD7325 Receives: Drug: AZD7325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scales
Measured: Daily during Visit 2 through 9
Secondary outcomes (1)
Columbia Suicide-Severity Rating Scale
Measured: Prior to each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMay 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recreational CNS Depressant UseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Myroslava K Romach, MD, Principal investigator, Kendle Early Stage - Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902772
- Sponsor's protocol ID
- D1140C00008
- Status last verified
- Sep 2009
- First submitted
- 12 May 2009
- Last updated
- 23 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00902772
- Acronym / sponsor ID
- D1140C00008
- Conditions
- Recreational CNS Depressant Use
- Keywords
- Recreational CNS depressant, Abuse liability, Abuse potential, Healthy Recreational CNS Depressant Users
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Study completion
- Sep 2009 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the abuse potential of AZD7325.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: PlaceboPlacebo |
| B | Active comparator | Drug: LorazepamLorazepam |
| C | Active comparator | Drug: LorazepamLorazepam |
| D | Active comparator | Drug: LorazepamLorazepam |
| E | Experimental | Drug: AZD7325AZD7325 |
| F | Experimental | Drug: AZD7325AZD7325 |
| G | Experimental | Drug: AZD7325AZD7325 |
Who may qualify
- Ages
- 18 months to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lorazepammg, oral dose | Drug | B, C, D |
| AZD7325mg, oral dose | Drug | E, F, G |
| Placebo | Drug | A |
Primary outcome
Visual Analog Scales
Time frame: Daily during Visit 2 through 9
1 secondary outcome
Columbia Suicide-Severity Rating Scale
Time frame: Prior to each treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myroslava K Romach, MD principal investigator
Kendle Early Stage - Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lorazepam and AZD7325 in people with Recreational CNS Depressant Use, run by AstraZeneca at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scales (time frame: Daily during Visit 2 through 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2009.