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Completed

NCT Number: NCT01563224

GABA-B Receptor Function in Healthy Volunteers

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.

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Key information

Age range

21 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Neuropsychopharmacology, Imperial College

London, W12 0NN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baclofen 10mg

Drug

Baclofen 10mg single dose po

Baclofen 60mg

Drug

Baclofen 60mg single dose po

Placebo

Drug

placebo

Primary outcomes

  1. EEG spectral power in theta band

    Time frame: Change from baseline to 4 hours after dosing

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Medical Research Council

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 26, 2012
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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