Exploring the Effects of Diazepam and Lorazepam

Healthy Subjects Clinical Trial

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Official title:

Exploring the Effects of Diazepam and Lorazepam on the Neural Correlates of Perceptual Priming and Explicit Memory in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696033
• Other study ID #: 3777
• Status: Completed
• Phase: N/A
• First received: June 9, 2008
• Last updated: September 16, 2009
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: September 2009
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
France	Centre d'investigation clinique, hôpital civil	Strasbourg
France	Clinique psychiatrique, hôpital civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Comparing lorazepam effects to diazepam (0.3 mg/kg)effects		After a single oral intake	No
Secondary	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	No