Exploring the Effects of Diazepam and Lorazepam

Condition(s) targeted: Healthy Subjects

Intervention: Diazepam (Drug); Lorazepam (Drug); placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: University Hospital, Strasbourg, France

Official(s) and/or principal investigator(s):
Pierre Vidailhet, MD, Principal Investigator, Affiliation: Hôpitaux universitaires de strasbourg

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

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

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

Primary outcome: 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

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 30 Years. Gender(s): Both.

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

Centre d'investigation clinique, hôpital civil, Strasbourg 67091, France

Clinique psychiatrique, hôpital civil, Strasbourg 67091, France

Starting date: July 2007
Last updated: September 16, 2009