GABA-B Receptor Function in Healthy Volunteers
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Purpose
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.
| Condition | Intervention |
|---|---|
|
No Condition Brain GABA-B Function |
Drug: Baclofen 10mg Drug: Baclofen 60mg Drug: placebo |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official 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 |
- EEG spectral power in theta band [ Time Frame: Change from baseline to 4 hours after dosing ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 8 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: single group, crossover, 3 interventions |
Drug: Baclofen 10mg
Baclofen 10mg single dose po
Drug: Baclofen 60mg
Baclofen 60mg single dose po
Drug: placebo
placebo
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 40 Years |
| Genders Eligible for Study: | Male |
| Accepts 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
Contacts and Locations| Contact: Sue Wilson, PhD | 02075947028 | sue.wilson@imperial.ac.uk |
| United Kingdom | |
| Neuropsychopharmacacology, Imperial College | |
| London, United Kingdom, W12 0NN | |
| Principal Investigator: | Anne Lingford-Hughes, MRCPsych PhD | Imperial College London |
More Information
No publications provided
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01563224 History of Changes |
| Other Study ID Numbers: | NOAA/001/2011 |
| Study First Received: | February 13, 2012 |
| Last Updated: | March 22, 2012 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by Imperial College London:
|
GABA-B |
Additional relevant MeSH terms:
|
Baclofen GABA-B Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Muscle Relaxants, Central Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013