Healthy SubjectsibidNCT00696033
Exploring the Effects of Diazepam and Lorazepam
A study testing Diazepam and Lorazepam in people with Healthy Subjects, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
Aims : exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI comparing lorazepam effects to diazepam (0.3 mg/kg)effects exploring benzodiazepines… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Diazepam and Lorazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2007to Dec 2008
- Phase
- Interventional
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects between 18 and 30 years
- Students in medicine, dentistry or pharmacy
- French as a mother language
Who cannot join
- Medical condition influencing brain function (neurological or psychiatric)
- Asthma
- General anesthesia in the 3 last months
- Drug addiction (DSM IV criteria)
- Regular medical treatment (except contraceptive pill)
- Significant impairment observed during a medical examination including ECG
Show all 14Show fewer
- Intake of any psychotropic drug that can have a effect during testing
- IQ (Wechsler) < 100
- FMRI contra-indication (implantable magnetic material, claustrophobia)
- Known allergy to benzodiazepine or lactose
- > 10 cigarettes/day
- Pregnant or breast-feeding woman
- No health insurance
- Subjects who do not complete the entire study
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre d'investigation clinique, hôpital civil
Strasbourg, 67091
Clinique psychiatrique, hôpital civil
Strasbourg, 67091
About this study
Official title: Exploring the Effects of Diazepam and Lorazepam on the Neural Correlates of Perceptual Priming and Explicit Memory in Healthy Volunteers
Aims :
- exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI
- comparing lorazepam effects to diazepam (0.3 mg/kg)effects
- exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI
Read more
Hypothesis :
- both diazepam and lorazepam will impair explicit memory performance, but lorazepam only will impair perceptual priming
- lorazepam and diazepam will modify the normal correlates of information encoding within explicit memory
- lorazepam only will alter the neural correlates of perceptual priming
- Conditions
- Healthy Subjects
- Being tested
- Diazepam, Lorazepam, placebo
- Keywords
- Benzodiazepines, Lorazepam, Diazepam, Memory, Perceptual priming, Functional brain imaging, FMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiazepamDrug
Diazépam drug (0,3 mg/kg) on a single oral intake
LorazepamDrug
Lorazépam drug (0,038 mg/kg) on a single oral intake
placeboDrug
lorazépam placebo or Diazépam placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral Lorazepam Receives: Drug: Lorazepam |
| 2 | Experimental | Oral Diazepam Receives: Drug: Diazepam |
| 3 | Placebo comparator | Oral placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI
Measured: After a single oral intake
Secondary outcomes (2)
Comparing lorazepam effects to diazepam (0.3 mg/kg)effects
Measured: After a single oral intake
Exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI
Measured: After single oral intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Vidailhet, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696033
- Sponsor's protocol ID
- 3777
- Acronym
- ibid
- Status last verified
- Sep 2009
- First submitted
- 9 Jun 2008
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Diazepam and Lorazepam on the Neural Correlates of Perceptual Priming and Explicit Memory in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00696033
- Acronym / sponsor ID
- ibid / 3777
- Conditions
- Healthy Subjects
- Keywords
- Benzodiazepines, Lorazepam, Diazepam, Memory, Perceptual priming, Functional brain imaging, FMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Jun 2008 (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.
Aims :
- exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI
- comparing lorazepam effects to diazepam (0.3 mg/kg)effects
- exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI
Hypothesis :
- both diazepam and lorazepam will impair explicit memory performance, but lorazepam only will impair perceptual priming
- lorazepam and diazepam will modify the normal correlates of information encoding within explicit memory
- lorazepam only will alter the neural correlates of perceptual priming
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LorazepamOral Lorazepam |
| 2 | Experimental | Drug: DiazepamOral Diazepam |
| 3 | Placebo comparator | Drug: placeboOral placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects between 18 and 30 years
- Students in medicine, dentistry or pharmacy
- French as a mother language
Key exclusion criteria (14 listed)
- Medical condition influencing brain function (neurological or psychiatric)
- Asthma
- General anesthesia in the 3 last months
- Drug addiction (DSM IV criteria)
- Regular medical treatment (except contraceptive pill)
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 |
|---|---|---|
| DiazepamDiazépam drug (0,3 mg/kg) on a single oral intake | Drug | 2 |
| LorazepamLorazépam drug (0,038 mg/kg) on a single oral intake | Drug | 1 |
| placebolorazépam placebo or Diazépam placebo | Drug | 3 |
Primary outcome
Exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI
Time frame: After a single oral intake
2 secondary outcomes
Comparing lorazepam effects to diazepam (0.3 mg/kg)effects
Time frame: After a single oral intake
Exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI
Time frame: After single oral intake
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 11 Sep 2025.
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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.
Pierre Vidailhet, MD principal investigator
Hôpitaux Universitaires de Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diazepam and Lorazepam in people with Healthy Subjects, run by University Hospital, Strasbourg, France at 2 sites in France.
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 14 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
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?
Exploring lorazepam (0.038 mg/kg) effects, after a single oral intake, in healthy volunteers, on the neural correlates of encoding and retrieval of information during a word-stem completion task (implicit memory), using fMRI (time frame: After a single oral intake). 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 11 Sep 2025.