Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-27 @ 2:05 PM
Study NCT ID:
NCT06650059
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2024-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort Study of Sickle Cell Patients Evaluating Analgesic Strategies and Their Consequences
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Cohort Study of Sickle Cell Patients Evaluating Analgesic Strategies and Their Consequences
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DDAM
Brief Summary:
To date, there is no comprehensive data among adults with sickle cell disease concerning the prevalence of consumption of level 2 and 3 analgesics at home and the use of cannabis or CBD for analgesic use. Preliminary data shows a very high prevalence of an opioid use disorder (OUD) in these patients, above 50%, but more precise additional studies are necessary to objectify these results and implement appropriate multidisciplinary care.
The general objective of this project is to establish an exhaustive collection on the addiction of sickle cell patients followed in a sickle cell reference center (hôpital Henri Mondor, hôpital Necker-Enfants Malades and hôpital européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris). The study investigative team proposes to set up a prospective observational study using a questionnaire.
The general objective of this project is to establish an exhaustive collection on the addiction of sickle cell patients followed in a sickle cell reference center (hôpital Henri Mondor, hôpital Necker-Enfants Malades and hôpital européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris). The study investigative team proposes to set up a prospective observational study using a questionnaire.
Detailed Description:
Sickle cell disease is one of the most common genetic diseases in the world with approximately 300,000 births per year of children with sickle cell disease. It is linked to the presence of a mutation on the beta globin chain (beta S mutation), responsible for the expression of the S variant of hemoglobin (HbS). Inherited autosomal recessively, is characterized, among other things, by intense painful vaso-occlusive crises (VOC) of bone triggered by cold, dehydration, stress or fatigue, but also sometimes without an identified triggering factor. The management of VOC requires, among other things, the rapid administration of analgesics. Level 1 seems ineffective and patients most often resort to level 2 from the start of symptoms, then level 3 in a hospital setting if the latter are ineffective. Sickle cell patients also frequently present with chronic pain, sometimes linked to complications of the disease (chronic leg ulcers, osteonecrosis in particular) but also without an identified cause.
The prescription of level 2 is therefore quite widely used in these patients for both the management of acute and chronic pain. In addition, self-management of pain has been encouraged for several years by caregivers, with the risk of more or less controlled self-medication, but little data is available in the literature.
Consequently, repeated exposure to opioids, as well as the painful context, constitute risk factors for the development of an opioid use disorder (OUD).
To date, there is no comprehensive data among adults with sickle cell disease concerning the prevalence of consumption of level 2 and 3 analgesics at home and the use of cannabis or CBD for analgesic use. Preliminary data shows a very high prevalence of OUD in these patients, above 50%, but more precise additional studies are necessary to objectify these results and implement appropriate multidisciplinary care.
The general objective of this project is to establish an exhaustive collection on the addiction of sickle cell patients followed in a sickle cell reference center (hôpital Henri Mondor, hôpital Necker-Enfants Malades and hôpital européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris). The study investigative team proposes to set up a prospective observational study using a questionnaire.
The prescription of level 2 is therefore quite widely used in these patients for both the management of acute and chronic pain. In addition, self-management of pain has been encouraged for several years by caregivers, with the risk of more or less controlled self-medication, but little data is available in the literature.
Consequently, repeated exposure to opioids, as well as the painful context, constitute risk factors for the development of an opioid use disorder (OUD).
To date, there is no comprehensive data among adults with sickle cell disease concerning the prevalence of consumption of level 2 and 3 analgesics at home and the use of cannabis or CBD for analgesic use. Preliminary data shows a very high prevalence of OUD in these patients, above 50%, but more precise additional studies are necessary to objectify these results and implement appropriate multidisciplinary care.
The general objective of this project is to establish an exhaustive collection on the addiction of sickle cell patients followed in a sickle cell reference center (hôpital Henri Mondor, hôpital Necker-Enfants Malades and hôpital européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris). The study investigative team proposes to set up a prospective observational study using a questionnaire.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A01209-38 | OTHER | IDRCB number | View |