Exploring the Effects of Diazepam and Lorazepam

Overview

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

Full Title of Study: “Exploring the Effects of Diazepam and Lorazepam on the Neural Correlates of Perceptual Priming and Explicit Memory in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2008

Interventions

  • Drug: Diazepam
    • Diazépam drug (0,3 mg/kg) on a single oral intake
  • Drug: Lorazepam
    • Lorazépam drug (0,038 mg/kg) on a single oral intake
  • Drug: placebo
    • lorazépam placebo or Diazépam placebo

Arms, Groups and Cohorts

  • Experimental: 1
    • Oral Lorazepam
  • Experimental: 2
    • Oral Diazepam
  • Placebo Comparator: 3
    • Oral placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Strasbourg, France
  • Provider of Information About this Clinical Study
    • Christine GEILLER, directeur Adjoint, University Hospital, Strasbourg, France
  • Overall Official(s)
    • Pierre Vidailhet, MD, Principal Investigator, Hôpitaux Universitaires de Strasbourg

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