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No Condition | GABA-B Receptor Function in Healthy Volunteers

No Condition research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

No Condition

Brain GABA-B Function

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Baclofen 10mgBaclofen 10mg single dose po

Drug:Baclofen 60mgBaclofen 60mg single dose po

Drug:placeboplacebo

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

single group, crossover, 3 interventions

Study Status

Completed

Start Date: July 2013

Completed Date: September 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: EEG spectral power in theta band

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Anne Lingford-Hughes, MRCPsych PhD

Lead Sponsor: Imperial College London

Collaborator: Medical Research Council

More information:https://clinicaltrials.gov/show/NCT01563224

Discuss Baclofen