Cohort Study of Sickle Cell Patients Evaluating Analgesic Strategies and Their Consequences

NCT06650059 | Completed

• 2 other identifiers: APHP2406352024-A01209-38
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 3

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.

Conditions

Sickle Cell Disease

Keywords

Sickle cell disease; Intense painful vaso-occlusive crises (VOC); Opioid use disorder (OUD)

Outcome Measures

Primary Outcomes (1)

• 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).

  Time 0

Secondary Outcomes (5)

• Cannabis use

  Time 0

• Consumption of CBD for analgesic purposes

  Time 0

• Tobacco consumption

  Time 0

• Use of vaping

  Time 0

• Factors linked to sickle cell disease and associated with substance use: opioids, cannabis, CBD and tobacco

  Time 0

Study Arms (1)

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).

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult sickle cell patient cared in one of the three reference centers (Necker Hospital, Mondor Hospital, Georges Pompidou European Hospital).

You may qualify if:

• 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.

You may not qualify if:

• Patient under guardianship or curatorship.
• Non-literate patient.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (3)

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital européen Georges-Pompidou

Paris, 75015, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (6)

• 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.

  PMID: 15157040 BACKGROUND

• Feliu 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.

  PMID: 21910605 BACKGROUND

• Al 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.

  PMID: 33026052 BACKGROUND

• Gerardin 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.

  PMID: 26573686 BACKGROUND

• Abrams 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.

  PMID: 32678452 BACKGROUND

• Gerardin 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.

  PMID: 33735176 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Opioid-Related Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Laure Joseph, M.D.

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Elena Foïs, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: December 1, 2024
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)