Condition category
Nervous System Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
27/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof M J Kendall

ORCID ID

Contact details

Clinical Investigation Unit
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265122314

Study information

Scientific title

Caffeine, catecholamines and tremor

Acronym

Study hypothesis

The study has 2 aims:
1. To investigate the short term effects of caffeine on tremor and relate them to other beta-2 mediated changes.
2. To investigate the nature of the tremor response to beta-2 agonists.
The generally accepted explanation for the tremorogenic effect of these drugs is that the twitch properties of the muscles are changed. The twitch becomes faster and the tetanic filsion frequency increases. As a consequence, for any likely rate of motor neuron firing the response of the muscle becomes more pulsatile. We will record tremor with a new isometric apparatus which allows this conclusion to be directly tested. Any component of the tremor which alternatively results from central activation can be distinguished by this new technique.
For information: Whairad HJ, Birmingham AT, MacDonald IA, Inch PJ, Mead JL. The influence of fasting and caffeine intake on finger tremor. European Journal of Clinical Pharmacology 1985:29;37-43. See http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=4054205&query_hl=7&itool=pubmed_docsum

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Nervous System Diseases: Tremor

Intervention

Suitable volunteers will be seen prior to entry to the study. A full history and examination will be performed, including details of smoking, alcohol and caffeine intake. They will be given a written information sheet and a full explanation of the nature and purpose of the study. They will be asked to sign a consent form if they wish to take part.
The study will consist of five visits to the clinical investigation unit each separated by at least 72 hours from the preceding and following study day. Prior to each study day the volunteer will abstain from caffeine containing foods and beverage for 48 hours and will not drink alcohol for the 24 hours preceding the investigation. Each visit will follow a standard protocol. The volunteer will attend and a cannula will be inserted into each ante-cubital fossa.
Baseline tremor and associated cutaneous electromyography (EMG), blood pressure and pulse rate will be measured using standard non-invasive techniques. Additionally a blood sample (to analyse for potassium, glucose and insulin concentrations) will be taker) prior to the volunteer receiving an oral dose of caffeine at 7mg/kg or placebo. 45 minutes after administration the volunteers' tremor, blood pressure and pulse rate will be measured and a blood sample taken. An infusion of the terbutaline (at either 2 or 7 µg/kg/minute or placebo (saline) at 35 ml/hour) intravenously infrised at the prescribed rate. The volunteers' tremor, blood pressure and pulse rate will be measured and a blood sample taken four more times at 15-minute intervals. The volunteer will then depart. This basic procedure will be repeated for each visit.

The volunteer will be required to attend five times in order to receive the following combinations:
An oral dose of caffeine at 7mg/kg with placebo infusion.
A placebo tablet with a terbutaline infusion of 2 µg/kg/hr set up and run for 45 minutes.
A placebo tablet with a terbutaline infusion of 7 µg/kg/hr set up and run for 45 minutes.
Caffeine at 7mg/kg plus Terbutaline infusion at 2 µg/kg/hr set up and run for 45 minutes.
Caffeine at 7mg/kg plus Terbutaline infusion at 7 µg/kg/hr set up and run for 45 minutes.
These different treatments will be performed in a randomized order.

Intervention type

Drug

Phase

Not Applicable

Drug names

Caffeine, terbutaline

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/03/2003

Overall trial end date

16/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

8 healthy volunteers aged 18-39 years of either sex will be recruited. They will each act as their own control. They will be taking no other medication (with the exception of the oral contraceptive pill).

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

8

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

16/03/2003

Recruitment end date

16/03/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Birmingham NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes