Sickle Cell DiseaseDDAMNCT06650059
Cohort Study of Sickle Cell Patients Evaluating Analgesic Strategies and Their Consequences
An observational study of Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Questionnaire
- How many people
- 257 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Dec 2024to 26 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult sickle cell patient cared in one of the three reference centers (Necker Hospital, Mondor Hospital, Georges Pompidou European Hospital).
Who may be able to join
- Adult patient.
- Sickle cell patient benefiting from a consultation or a session in a day hospital in one of the three reference centers (Necker Hospital, Mondor Hospital, Georges Pompidou European Hospital).
- Patient informed of the study and not opposed to participating in the research.
Who cannot join
- Patient under guardianship or curatorship.
- Non-literate patient.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Henri Mondor
Créteil, 94010
Hôpital européen Georges-Pompidou
Paris, 75015
Hôpital Necker-Enfants Malades
Paris, 75015
About this study
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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Questionnaire
- Keywords
- Sickle cell disease, Intense painful vaso-occlusive crises (VOC), Opioid use disorder (OUD)
- Medical subject headings
- Anemia, Sickle Cell, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Self-questionnaire intended to each patient with sickle cell disease seen in consultation in one of the three reference centers participating in the study. Patients will complete the questionnaire once, on site.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Adult 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). Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of opioid use disorder
The diagnosis of OUD will be established according to the criteria of the 5th version of the Diagnostic and Statistical Manual of Mental Illnesses (DSM 5). In this version the diagnosis of a use disorder is made if a patient meets 2 criteria among the 11 specified over a period of at least 12 months. These criteria cover four dimensions: loss of control over consumption (4 criteria), social impairment of functioning (3 criteria), continuation of use despite the risks incurred or presented (2 criteria), and physical symptoms (2 criteria). Depending on the number of criteria met, a gradation of severity is established: mild OUD (2 to 3 criteria), moderate (4 to 5 criteria), or severe (6 criteria or more).
Measured: Time 0
Secondary outcomes (5)
Cannabis use
Current and past cannabis consumption will be assessed by a closed question. As for problematic use, it will be sought using the CAST questionnaire (Cannabis Abuse Screening Test), a 6-item scale that describes the behavior of use or problems experienced within the scope of cannabis use. Each of these items describes usage behaviors or problems encountered in the context of cannabis consumption:on use in the morning or alone, that is to say assumed outside of a festive context; possible disorders of the memory; being encouraged to reduce or stop drinking; failures in attempts to stop; problems such as fights, accidents, etc. following consumption of cannabis. The effects felt after taking cannabis will also be researched. To calculate the score, the modalities are coded from 0 to 4. The total obtained vary from 0 to 24.A risk-free users is defined when they have a score less than 3, the users with a low risk for a score = 3 and <7 and a high risk dependency for a score = or ˃7.
Measured: Time 0
Consumption of CBD for analgesic purposes
CBD consumption for analgesic purposes will be assessed by a closed question.
Measured: Time 0
Tobacco consumption
The existence of tobacco consumption will be assessed by a closed question on current and lifetime smoking. The severity of dependence will be assessed by the Fagerström questionnaire. It includes 10 questions relating to the smoker's consumption habits. Depending on the answers given, a score of 0 to 10 is obtained; dependence is thus judged to be zero if the score is 0 to 2, weak 3 or 4, average 5 or 6, strong 7 or 8 and very strong 9 or 10.
Measured: Time 0
Use of vaping
The use of vaping will be assessed by a closed question.
Measured: Time 0
Factors linked to sickle cell disease and associated with substance use: opioids, cannabis, CBD and tobacco
The factors linked to sickle cell disease and associated with the use of substances: opioids, cannabis, CBD and tobacco, will be collected by closed questions and are :
- Patient characteristics: sex, country, month and year of birth, marital status, professional activity,
- History of sickle cell disease: description and evolution of vaso-occlusive crises (VOC), chronic pain, and complications,
- Current therapies: current drug treatments, use of analgesics during the last 12 months, and other non-drug therapies.
Measured: Time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Dec 2024
- Primary completion26 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Laure Joseph, M.D., Principal investigator, Assistance Publique - Hôpitaux de ParisElena Foïs, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650059
- Sponsor's protocol ID
- APHP240635
- Other IDs
- 2024-A01209-38
- Acronym
- DDAM
- Status last verified
- Nov 2025
- First submitted
- 17 Oct 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elander J, Lusher J, Bevan D, Telfer P, Burton B. Understanding the causes of problematic pain management in sickle cell disease: evidence that pseudoaddiction plays a more important role than genuine analgesic dependence. J Pain Symptom Manage. 2004 Feb;27(2):156-69. doi: 10.1016/j.jpainsymman.2003.12.001.
PubMed 15157040Feliu MH, Wellington C, Crawford RD, Wood M, Edwards L, Byrd G, Edwards CL. Opioid management and dependency among adult patients with sickle cell disease. Hemoglobin. 2011;35(5-6):485-94. doi: 10.3109/03630269.2011.610914. Epub 2011 Sep 12.
PubMed 21910605Al Zahrani O, Hanafy E, Mukhtar O, Sanad A, Yassin W. Outcomes of multidisciplinary team interventions in the management of sickle cell disease patients with opioid use disorders. A retrospective cohort study. Saudi Med J. 2020 Oct;41(10):1104-1110. doi: 10.15537/smj.2020.10.25386.
PubMed 33026052Gerardin M, Couec ML, Grall-Bronnec M, Feuillet F, Wainstein L, Rousselet M, Pinot ML, Perrouin F, Bonnot O, Drouineau MH, Jolliet P, Victorri-Vigneau C. PHEDRE trial protocol - observational study of the prevalence of problematic use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and analgesics in the French sickle-cell disease population. BMC Psychiatry. 2015 Nov 14;15:281. doi: 10.1186/s12888-015-0677-5.
PubMed 26573686Abrams DI, Couey P, Dixit N, Sagi V, Hagar W, Vichinsky E, Kelly ME, Connett JE, Gupta K. Effect of Inhaled Cannabis for Pain in Adults With Sickle Cell Disease: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jul 1;3(7):e2010874. doi: 10.1001/jamanetworkopen.2020.10874.
PubMed 32678452Gerardin M, Rousselet M, Couec ML, Masseau A, Guerlais M, Authier N, Deheul S, Roussin A, Micallef J, Djezzar S; French Addictovigilance Network (FAN); Feuillet F, Jolliet P, Victorri-Vigneau C. Descriptive analysis of sickle cell patients living in France: The PHEDRE cross-sectional study. PLoS One. 2021 Mar 18;16(3):e0248649. doi: 10.1371/journal.pone.0248649. eCollection 2021.
PubMed 33735176
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Sickle Cell Patients Evaluating Analgesic Strategies and Their Consequences
- ClinicalTrials.gov ID
- NCT06650059
- Acronym / sponsor ID
- DDAM / APHP240635
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle cell disease, Intense painful vaso-occlusive crises (VOC), Opioid use disorder (OUD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: QuestionnaireAdult 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult sickle cell patient cared in one of the three reference centers (Necker Hospital, Mondor Hospital, Georges Pompidou European Hospital).
Key inclusion criteria (3 listed)
- Adult patient.
- Sickle cell patient benefiting from a consultation or a session in a day hospital in one of the three reference centers (Necker Hospital, Mondor Hospital, Georges Pompidou European Hospital).
- Patient informed of the study and not opposed to participating in the research.
Key exclusion criteria (2 listed)
- Patient under guardianship or curatorship.
- Non-literate patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireSelf-questionnaire intended to each patient with sickle cell disease seen in consultation in one of the three reference centers participating in the study. Patients will complete the questionnaire once, on site. | Other | Patients |
Primary outcome
Diagnosis of opioid use disorder
Time frame: Time 0
The diagnosis of OUD will be established according to the criteria of the 5th version of the Diagnostic and Statistical Manual of Mental Illnesses (DSM 5). In this version the diagnosis of a use disorder is made if a patient meets 2 criteria among the 11 specified over a period of at least 12 months. These criteria cover four dimensions: loss of control over consumption (4 criteria), social impairment of functioning (3 criteria), continuation of use despite the risks incurred or presented (2 criteria), and physical symptoms (2 criteria). Depending on the number of criteria met, a gradation of severity is established: mild OUD (2 to 3 criteria), moderate (4 to 5 criteria), or severe (6 criteria or more).
5 secondary outcomes
Cannabis use
Time frame: Time 0
Consumption of CBD for analgesic purposes
Time frame: Time 0
Tobacco consumption
Time frame: Time 0
Use of vaping
Time frame: Time 0
Factors linked to sickle cell disease and associated with substance use: opioids, cannabis, CBD and tobacco
Time frame: Time 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 15157040Elander J, Lusher J, Bevan D, Telfer P, Burton B. Understanding the causes of problematic pain management in sickle cell disease: evidence that pseudoaddiction plays a more important role than genuine analgesic dependence. J Pain Symptom Manage. 2004 Feb;27(2):156-69. doi: 10.1016/j.jpainsymman.2003.12.001.
- Background: PubMed 21910605Feliu MH, Wellington C, Crawford RD, Wood M, Edwards L, Byrd G, Edwards CL. Opioid management and dependency among adult patients with sickle cell disease. Hemoglobin. 2011;35(5-6):485-94. doi: 10.3109/03630269.2011.610914. Epub 2011 Sep 12.
- Background: PubMed 33026052Al Zahrani O, Hanafy E, Mukhtar O, Sanad A, Yassin W. Outcomes of multidisciplinary team interventions in the management of sickle cell disease patients with opioid use disorders. A retrospective cohort study. Saudi Med J. 2020 Oct;41(10):1104-1110. doi: 10.15537/smj.2020.10.25386.
- Background: PubMed 26573686Gerardin M, Couec ML, Grall-Bronnec M, Feuillet F, Wainstein L, Rousselet M, Pinot ML, Perrouin F, Bonnot O, Drouineau MH, Jolliet P, Victorri-Vigneau C. PHEDRE trial protocol - observational study of the prevalence of problematic use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and analgesics in the French sickle-cell disease population. BMC Psychiatry. 2015 Nov 14;15:281. doi: 10.1186/s12888-015-0677-5.
- Background: PubMed 32678452Abrams DI, Couey P, Dixit N, Sagi V, Hagar W, Vichinsky E, Kelly ME, Connett JE, Gupta K. Effect of Inhaled Cannabis for Pain in Adults With Sickle Cell Disease: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jul 1;3(7):e2010874. doi: 10.1001/jamanetworkopen.2020.10874.
- Background: PubMed 33735176Gerardin M, Rousselet M, Couec ML, Masseau A, Guerlais M, Authier N, Deheul S, Roussin A, Micallef J, Djezzar S; French Addictovigilance Network (FAN); Feuillet F, Jolliet P, Victorri-Vigneau C. Descriptive analysis of sickle cell patients living in France: The PHEDRE cross-sectional study. PLoS One. 2021 Mar 18;16(3):e0248649. doi: 10.1371/journal.pone.0248649. eCollection 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laure Joseph, M.D. principal investigator
Assistance Publique - Hôpitaux de Paris
Elena Foïs, MD study director
Assistance Publique - Hôpitaux de Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of opioid use disorder (time frame: Time 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06650059, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.