GABA-B Receptor Function in Healthy Volunteers

Not Applicable

Completed

• Conditions: No Condition; Brain GABA-B Function
• Interventions: Drug: Baclofen 10mg; Drug: Baclofen 60mg; Drug: placebo

• Registration Number: NCT01563224
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-26
• Study Start: 2013-07
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
single group, crossover, 3 interventions	Baclofen 10mg	-
single group, crossover, 3 interventions	Baclofen 60mg	-
single group, crossover, 3 interventions	placebo	-

Primary Outcome Measures

Name	Time	Method
EEG spectral power in theta band	Change from baseline to 4 hours after dosing

Trial Locations

Locations (1)

Neuropsychopharmacology, Imperial College; 🇬🇧 London, United Kingdom