GABA-B Receptor Function in Healthy Volunteers

No Condition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563224
• Other study ID #: NOAA/001/2011
• Status: Completed
• Phase: N/A
• First received: February 13, 2012
• Last updated: June 3, 2015
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 40 Years

Eligibility

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

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Brain GABA-B Function
• No Condition

Intervention

Drug:
• Baclofen 10mg
Baclofen 10mg single dose po
• Baclofen 60mg
Baclofen 60mg single dose po
• placebo
placebo

Locations

Country	Name	City	State
United Kingdom	Neuropsychopharmacology, Imperial College	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG spectral power in theta band		Change from baseline to 4 hours after dosing	No