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
  Purpose

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 Intervention
No Condition
Brain GABA-B Function
Drug: Baclofen 10mg
Drug: Baclofen 60mg
Drug: placebo

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • EEG spectral power in theta band [ Time Frame: Change from baseline to 4 hours after dosing ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: July 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single group, crossover, 3 interventions Drug: Baclofen 10mg
Baclofen 10mg single dose po
Drug: Baclofen 60mg
Baclofen 60mg single dose po
Drug: placebo
placebo

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.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563224

Contacts
Contact: Sue Wilson, PhD 02075947026 sue.wilson@imperial.ac.uk

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

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01563224     History of Changes
Other Study ID Numbers: NOAA/001/2011
Study First Received: February 13, 2012
Last Updated: January 9, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Imperial College London:
GABA-B

Additional relevant MeSH terms:
Baclofen
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014