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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01563224
Enrollment
8
Registered
2012-03-26
Start date
2013-07-31
Completion date
2014-09-30
Last updated
2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain GABA-B Function, No Condition

Keywords

GABA-B

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.

Interventions

Baclofen 10mg single dose po

Baclofen 60mg single dose po

DRUGplacebo

placebo

Sponsors

Medical Research Council
CollaboratorOTHER_GOV
Imperial College London
Lead SponsorOTHER

Study design

Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
21 Years to 40 Years
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

Design outcomes

Primary

MeasureTime frame
EEG spectral power in theta bandChange from baseline to 4 hours after dosing

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026