Clinical trial NCT00696033: Exploring the Effects of Diazepam and Lorazepam
Official title: Exploring the Effects of Diazepam and Lorazepam on the Neural Correlates of Perceptual Priming and Explicit Memory in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: Benzodiazepines
Lorazepam
Diazepam
Memory
Perceptual priming
Functional brain imaging
FMRI
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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 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


Eligibility criteria: Inclusion Criteria:

* Healthy subjects between 18 and 30 years
* Students in medicine, dentistry or pharmacy
* French as a mother language

Exclusion criteria:

* 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
* 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

Primary outcomes:
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
timeFrame: After a single oral intake
Secondary outcomes:
measure: Comparing lorazepam effects to diazepam (0.3 mg/kg)effects
timeFrame: After a single oral intake
measure: Exploring benzodiazepines effects, after a single oral intake, on the neural correlates of successful encoding of information within explicit memory using fMRI
timeFrame: After single oral intake
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre d'investigation clinique, hôpital civil
city: Strasbourg
country: France
facility: Clinique psychiatrique, hôpital civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Pierre Vidailhet, MD
role: PRINCIPAL_INVESTIGATOR
References: