Clinical trial NCT01563224: GABA-B Receptor Function in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Condition
Brain GABA-B Function
Keywords: GABA-B
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2012-03-26
Enrollment: 8
Sex: MALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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 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

Primary outcomes:
measure: EEG spectral power in theta band
timeFrame: Change from baseline to 4 hours after dosing
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Neuropsychopharmacology, Imperial College
Study officials:
affiliation: Imperial College London
name: Anne Lingford-Hughes, MRCPsych PhD
role: PRINCIPAL_INVESTIGATOR
References: