Study of blood concentrations of morphine after oral administration of immediate release morphine in subject who have undergone a bariatric surgery called Roux-en-Y Gastric Bypass for a long time, in comparison with subjects who did not undergo surgery.

Phase 1

• Conditions: Subjects volunteers who undergone Roux-en-Y gastric bypass (RYGB) for at least 48 months and control subjects matched for BMI, age and sex; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-001143-40-FR
• Lead Sponsor: Therapeutic Research Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-28
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

RYGB Group (n=12)
-Subjects who undergone RYGB for at least 48 months included in OBEMO1 ans OBEMO2
- Stable weight since almost one year (or weight loss below 10kg over the last year)

Control group (n=12)
-Volunteers subjects, matched for age, sex, and Body mass index
-No history of bariatric surgery

Same characteristics
-Subjects volunteers for the study
-Age 20-70 years
-Written consent
- Drug addiction score according to criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) < 2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

- Individuals under the protection of a conservaor, curatorship, guardianship
-Uncontrolles seizures
-Known allergy to morphine or naloxone
-Patients not affiliated to the french social security system.
-Subjects yet recruited in a study with remuneration
-Abnormalities in liver function (TP<70%and/or ASAT>5N and/or ALAT>5N) and/or in renal function (creatinine clearance MDRD<60ml/min)
- Respiratory insufficiency defined by an oxigen saturation below 90%.
-Pregnancy and breastfeeding
-Use of drugs contra-indicated or not advised with morphine:
•Agonists-antagonists Opioids (buprenorphine, nalbuphine, pentazocine), Naltrexone
•Alcohol intake> 30g by day
•Cough medicine morphine-like (dextromethorphan, noscapin, pholcodin)
• Codeine, éthylmorphine
•Other morphine agonists (alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidin, phenoperidin, remifentanil, sufentanil, tramadol)
•Barbiturates, Benzodiazepines.
•Rifampicin
- Drug addiction score according to criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) = 2
Morphine/ opiate addiction or abuse, or history of morphine/ opiate addiction or abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified