Exploring the Effects of Diazepam and Lorazepam

NCT ID: NCT00696033

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Oral Lorazepam

Group Type EXPERIMENTAL

Lorazepam

Intervention Type DRUG

Lorazépam drug (0,038 mg/kg) on a single oral intake

2

Oral Diazepam

Group Type EXPERIMENTAL

Diazepam

Intervention Type DRUG

Diazépam drug (0,3 mg/kg) on a single oral intake

3

Oral placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

lorazépam placebo or Diazépam placebo

Interventions

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Diazepam

Diazépam drug (0,3 mg/kg) on a single oral intake

Intervention Type DRUG

Lorazepam

Lorazépam drug (0,038 mg/kg) on a single oral intake

Intervention Type DRUG

placebo

lorazépam placebo or Diazépam placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Vidailhet, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

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Centre d'investigation clinique, hôpital civil

Strasbourg, , France

Site Status

Clinique psychiatrique, hôpital civil

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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3777

Identifier Type: -

Identifier Source: org_study_id

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