GABA-B Receptor Function in Healthy Volunteers

NCT01563224 | Completed

• 1 other identifier: NOAA/001/2011
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

No Condition; Brain GABA-B Function

Keywords

GABA-B

Outcome Measures

Primary Outcomes (1)

• EEG spectral power in theta band

  Change from baseline to 4 hours after dosing

Study Arms (1)

single group, crossover, 3 interventions

EXPERIMENTAL

Drug: Baclofen 10mg; Drug: Baclofen 60mg; Drug: placebo

Interventions

Baclofen 10mg DRUG

Baclofen 10mg single dose po

single group, crossover, 3 interventions

Baclofen 60mg DRUG

Baclofen 60mg single dose po

single group, crossover, 3 interventions

placebo DRUG

placebo

single group, crossover, 3 interventions

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Currently healthy
• Non-smoker
• Willing to comply with protocol
• Excellent understanding of English (for questionnaires)
• Alcohol consumption between 1 and 28 units/week

You may not qualify if:

• Current or past history of psychiatric or substance use disorder

Sponsors & Collaborators

• Imperial College London: lead
• Medical Research Council: collaborator

Study Sites (1)

Neuropsychopharmacology, Imperial College

London, W12 0NN, United Kingdom

Location

MeSH Terms

Interventions

Baclofen

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Anne Lingford-Hughes, MRCPsych PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: March 26, 2012
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 4, 2015

Record last verified: 2014-09

Locations

GB (1)