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GABA-B Receptor Function in Healthy Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Imperial College London
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01563224
First received: February 13, 2012
Last updated: January 9, 2014
Last verified: December 2013

February 13, 2012
January 9, 2014
July 2013
March 2014   (final data collection date for primary outcome measure)
EEG spectral power in theta band [ Time Frame: Change from baseline to 4 hours after dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01563224 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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GABA-B Receptor Function in Healthy Volunteers
GABA-B Receptor Function in Healthy Volunteers: a Pilot, Double Blind Crossover Study of the Effects of 2 Doses of Baclofen and Placebo on Objective and Subjective Measurements of Brain Function

There are several developing lines of evidence suggesting that brain receptors called GABA-B receptors play a significant role in addiction and its treatment. The investigators wish to examine the sensitivity of brain GABA-B receptors in alcohol and opiate addicts as part of the investigators MRC programme of research in neurotransmitters in alcohol and opiate addiction (NOAA). In this present study the investigators will give 2 different single doses of a drug called baclofen, and a placebo, to 8 healthy male volunteers. This drug affects GABA-B receptors in the central nervous system and is licensed for the treatment of spasticity in people with eg spinal injuries; the investigators are interested in its effects on brain GABA-B receptors. The investigators will measure EEG (brainwaves), eye movements, blood pressure and heart rate, motor co-ordination and subjective effects and also blood levels of the drug in the investigators volunteers before and at intervals after dosing. The investigators will use a double-blind randomised design to minimise expectation effects. The study will provide information on timing and magnitude of effects of baclofen on brain function in healthy subjects so that the investigators can optimise selection and timing of functional measures in future studies of addicts.

After informed consent and screening participants will attend for 3 study days. On each of these there will be a set of baseline measurements including EEG, saccadic eye movements, vital signs, motor co-ordination task, subjective visual analogue ratings and questionnaires and blood sample. After dosing these measurements will be repeated at intervals during the day up to 6 hours after dosing. Participants will be allowed home after a health check.

Interventional
Not Provided
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • No Condition
  • Brain GABA-B Function
  • Drug: Baclofen 10mg
    Baclofen 10mg single dose po
  • Drug: Baclofen 60mg
    Baclofen 60mg single dose po
  • Drug: placebo
    placebo
Experimental: single group, crossover, 3 interventions
Interventions:
  • Drug: Baclofen 10mg
  • Drug: Baclofen 60mg
  • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently healthy
  • Non-smoker
  • Willing to comply with protocol
  • Excellent understanding of English (for questionnaires)
  • Alcohol consumption between 1 and 28 units/week

Exclusion Criteria:

  • Current or past history of psychiatric or substance use disorder
Male
21 Years to 40 Years
Yes
Contact: Sue Wilson, PhD 02075947026 sue.wilson@imperial.ac.uk
United Kingdom
 
NCT01563224
NOAA/001/2011
No
Imperial College London
Imperial College London
Medical Research Council
Principal Investigator: Anne Lingford-Hughes, MRCPsych PhD Imperial College London
Imperial College London
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP