Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01563224
Other study ID # NOAA/001/2011
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02265224 - Bioequivalence Study of Two Different Formulations of N-acetyl-cysteine (NAC) Phase 1
Completed NCT00379210 - Neural Effects of Mindfulness Training on Attention N/A
Completed NCT05901220 - Joint School-Health Project of the Neapolitan Child N/A
Active, not recruiting NCT04455295 - Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation N/A
Not yet recruiting NCT03225638 - Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®) N/A
Completed NCT04854642 - A Single Dose Study About the Influence of Food on the Oral Bioavailability of Ladarixin Capsule in Healthy Volunteers Phase 1
Terminated NCT04803396 - Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple Oral Intake of DF2755A Phase 1
Recruiting NCT03134482 - Comparison of Clinical Outcomes Between IVM and Minimal Stimulation IVF in Patients With PCOS N/A
Completed NCT05882942 - Matcha Green Tea Effects at Rest and During Moderate-intensity Exercise in Females N/A
Completed NCT03044301 - Performance Thresholds Evaluation by Wet Injection Quantification and Magnetic Resonance Imaging (MRI) of Subcutaneous and Intramuscular Injections (0,65ml) of Several Configurations of Needle-free Devices (ZENEO®) N/A
Terminated NCT04227405 - TOGETHER: A Couple's Model to Enhance Relationships and Economic Stability N/A
Completed NCT04802967 - A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males Phase 1