GABA-B Receptor Function in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01563224
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : June 4, 2015
Medical Research Council
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
No Condition Brain GABA-B Function Drug: Baclofen 10mg Drug: Baclofen 60mg Drug: placebo Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : July 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen
U.S. FDA Resources

Arm Intervention/treatment
Experimental: single group, crossover, 3 interventions Drug: Baclofen 10mg
Baclofen 10mg single dose po
Drug: Baclofen 60mg
Baclofen 60mg single dose po
Drug: placebo

Primary Outcome Measures :
  1. EEG spectral power in theta band [ Time Frame: Change from baseline to 4 hours after dosing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01563224

United Kingdom
Neuropsychopharmacology, Imperial College
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Medical Research Council
Principal Investigator: Anne Lingford-Hughes, MRCPsych PhD Imperial College London

Responsible Party: Imperial College London Identifier: NCT01563224     History of Changes
Other Study ID Numbers: NOAA/001/2011
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: September 2014

Keywords provided by Imperial College London: