Condition category
Respiratory
Date applied
03/07/2006
Date assigned
04/07/2006
Last edited
16/02/2007
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 Albert Dahan

ORCID ID

Contact details

Leiden University Medical Center (LUMC)
Department of Anesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
adahan@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

This is a pharmacological study to examine the ability to reverse respiratory depression from opioids such as morphine and Morphine-6-Glucuronide (M6G) using low-dose naloxone.

Ethics approval

Approval received by the Ethics Committee of Leiden University Medical Center on the 6th July 2005 (ref: P04.004).

Study design

Randomised, parallel, placebo-controlled, double-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Respiratory depression by opioids

Intervention

Measurement of respiration on a breath-to-breath basis. We will study four groups, with 12 subjects per group:
1. Group one will receive M6G 0.2 mg/ kg
2. Group two will receive M6G 0.4 mg/kg
3. Group three will receive morphine 0.15 mg/kg
4. Group four will receive morphine 0.3 mg/kg

These opioids will be administered intravenously as a bolus dose, 90 minutes after the opioid infusion, naloxone will be infused using a target controlled infusion system for one hour. Next measurement will continue for another two hours. The opioid doses to be used are based on previous studies as well on clinical efficacy.

Intervention type

Drug

Phase

Not Specified

Drug names

Naloxone, morphine, morphine-6-glucuronide

Primary outcome measures

Minute ventilation and pain response to heat pain

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2005

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy volunteers over 18 years of age

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Obesity (Body Mass Index [BMI] more than 30)
2. Presence of medical disease (heart, lung, liver, kidney, neurological disease, diabetes, pyrosis, diaphragmatic hernia)
3. Presence of psychiatric disease
4. History of chronic alcohol or drug use
5. Allergy to study medications
6. Possibility of pregnancy
7. Lactating females

Recruitment start date

01/01/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/

Funders

Funder type

Industry

Funder name

CeNes Ltd (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