Reversal of the respiratory effect of morphine and morphine-6-glucuronide by naloxone: a clinical study using healthy volunteers
| ISRCTN | ISRCTN59442355 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59442355 |
| Protocol serial number | N/A |
| Sponsor | Leiden University Medical Centre (LUMC) (The Netherlands) |
| Funder | CeNes Ltd (UK) |
- Submission date
- 03/07/2006
- Registration date
- 04/07/2006
- Last edited
- 26/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Albert Dahan
Scientific
Scientific
Leiden University Medical Center (LUMC)
Department of Anesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| adahan@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, parallel, placebo-controlled, double-blinded trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Reversal of the respiratory effect of morphine and morphine-6-glucuronide by naloxone: a clinical study using healthy volunteers |
| Study objectives | 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(s) | Approval received by the Ethics Committee of Leiden University Medical Center on the 6th July 2005 (ref: P04.004). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Naloxone, morphine, morphine-6-glucuronide |
| Primary outcome measure(s) |
Minute ventilation and pain response to heat pain |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 24 |
| Key inclusion criteria | Healthy volunteers over 18 years of age |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2010 | 26/03/2021 | Yes | No |
Editorial Notes
26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
