Exploring the Effects of Diazepam and Lorazepam

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Lorazepam; Drug: Diazepam; Drug: placebo

• Registration Number: NCT00696033
• Lead Sponsor: University Hospital, Strasbourg, France

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-16
• Last Update Posted: 2009-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Lorazepam	Oral Lorazepam
2	Diazepam	Oral Diazepam
3	placebo	Oral placebo

Primary Outcome Measures

Name	Time	Method
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	After a single oral intake

Secondary Outcome Measures

Name	Time	Method
Comparing lorazepam effects to diazepam (0.3 mg/kg)effects	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	After single oral intake

Trial Locations

Locations (2)

Centre d'investigation clinique, hôpital civil; 🇫🇷 Strasbourg, France

Clinique psychiatrique, hôpital civil; 🇫🇷 Strasbourg, France