GABA-B Receptor Function in Healthy Volunteers

NCT ID: NCT01563224

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-09-30

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.

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.

Conditions

No Condition; Brain GABA-B Function

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

single group, crossover, 3 interventions

Group Type: EXPERIMENTAL

Baclofen 10mg

Intervention Type: DRUG

Baclofen 10mg single dose po

Baclofen 60mg

Intervention Type: DRUG

Baclofen 60mg single dose po

placebo

Intervention Type: DRUG

placebo

Interventions

Baclofen 10mg

Baclofen 10mg single dose po

Intervention Type: DRUG

Baclofen 60mg

Baclofen 60mg single dose po

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Lingford-Hughes, MRCPsych PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Neuropsychopharmacology, Imperial College

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

NOAA/001/2011

Identifier Type: -

Identifier Source: org_study_id