Exploring the Effects of Diazepam and Lorazepam (ibid)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00696033
First received: June 9, 2008
Last updated: September 16, 2009
Last verified: September 2009
  Purpose

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

Condition Intervention
Healthy Subjects
Drug: Diazepam
Drug: Lorazepam
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Exploring the Effects of Diazepam and Lorazepam on the Neural Correlates of Perceptual Priming and Explicit Memory in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparing lorazepam effects to diazepam (0.3 mg/kg)effects [ Time Frame: After a single oral intake ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral Lorazepam
Drug: Lorazepam
Lorazépam drug (0,038 mg/kg) on a single oral intake
Experimental: 2
Oral Diazepam
Drug: Diazepam
Diazépam drug (0,3 mg/kg) on a single oral intake
Placebo Comparator: 3
Oral placebo
Drug: placebo
lorazépam placebo or Diazépam placebo

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696033

Locations
France
Clinique psychiatrique, hôpital civil
Strasbourg, France, 67091
Centre d'investigation clinique, hôpital civil
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Pierre Vidailhet, MD Hôpitaux universitaires de strasbourg
  More Information

No publications provided

Responsible Party: Christine GEILLER, directeur Adjoint, University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00696033     History of Changes
Other Study ID Numbers: 3777
Study First Received: June 9, 2008
Last Updated: September 16, 2009
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Benzodiazepines
Lorazepam
Diazepam
Memory
Perceptual priming
Functional brain imaging
FMRI

Additional relevant MeSH terms:
Diazepam
Lorazepam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014