Exploring the Effects of Diazepam and Lorazepam - Full Text View

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00696033

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

MedlinePlus related topics: Memory

Drug Information available for: Diazepam Lorazepam

U.S. FDA Resources

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

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
1: Experimental Oral Lorazepam	Drug: Lorazepam Lorazépam drug (0,038 mg/kg) on a single oral intake
2: Experimental Oral Diazepam	Drug: Diazepam Diazépam drug (0,3 mg/kg) on a single oral intake
3: Placebo Comparator 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

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

Responsible Party:	University Hospital, Strasbourg, France ( Emmanuel LAVOUE, directeur Adjoint )
Study ID Numbers:	3777
Study First Received:	June 9, 2008
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00696033
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:

Benzodiazepines
Lorazepam
Diazepam
Memory

Perceptual priming
Functional brain imaging
FMRI

Study placed in the following topic categories:

Lorazepam
Diazepam
Healthy

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Anesthetics
Antiemetics
Central Nervous System Depressants
Neuromuscular Agents

Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Autonomic Agents
Therapeutic Uses
Muscle Relaxants, Central
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 15, 2009