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| Name | Class |
|---|---|
| Medical Research Council | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single group, crossover, 3 interventions | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen 10mg | Drug | Baclofen 10mg single dose po |
| |
| Measure | Description | Time Frame |
|---|---|---|
| EEG spectral power in theta band | Change from baseline to 4 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Lingford-Hughes, MRCPsych PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychopharmacology, Imperial College | London | W12 0NN | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 19, 2019 | |
| Reset | Sep 19, 2019 | |
| Release | Apr 5, 2023 | |
| Reset | Jan 10, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 19, 2019 | Sep 19, 2019 | |||
| Apr 5, 2023 |
| ID | Term |
|---|---|
| D001418 | Baclofen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Baclofen 60mg |
| Drug |
Baclofen 60mg single dose po |
|
| placebo | Drug | placebo |
|
| Jan 10, 2024 |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |