Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease

NCT02580565 | Completed

• 1 other identifier: RC14_0344
• Study Type: observational
• Target: 1,004
• Locations: 0 countries
• Sites: N/A

Brief Summary

The use of analgesics can lead to cases of drug abuse and dependence. It can also cause pseudo-addiction in patients suffering from pain. What is the actual situation in patients suffering from severe sickle-cell disease, exposed to acute pain during vaso-occlusive crises? Evaluation of the use of analgesics, on the basis of Diagnostic and Statistical Manual of Mental Disorders criteria for substance abuse and dependence, makes it possible to differentiate the symptoms occurring only in a context of pain, in the aim of managing the pain, and thus describing pseudo-addiction, from symptoms also occurring when there is no pain, and more in favour of true addiction. Currently there is no data available in France on this problem, and no studies have been carried out in children or adolescents with sickle-cell disease. The purpose of the study is to evaluate the prevalence of problematic use of equimolar mixture of oxygen and nitrous oxide and other analgesic drugs in a population of subjects with severe sickle-cell disease in France. PHEDRE (Pharmacodépendance Et DREpanocytose-drug dependence and sickle-cell disease) is an observational, descriptive and transversal study. Patients under the age of 26 with sickle-cell disease are included in the study by the doctors looking after them in sickle-cell disease centres. The patients are then contacted by a trained researcher for a telephone interview, including an evaluation of the Diagnostic and Statistical Manual of Mental Disorders criteria for abuse and dependence to equimolar mixture of oxygen and nitrous oxide and for each of the analgesic drugs taken by the patient. The data are also completed using the subject's medical record. This study will make it possible to provide an initial quantitative and qualitative evaluation of problematic use of equimolar mixture of oxygen and nitrous oxide and analgesic drugs in the sickle-cell disease population. The results will be used firstly to provide additional data essential for monitoring the risk of overdose, abuse, dependence and misuse of these products, and to begin awareness-raising and to provide information for health care professionals, in order to significantly improve the management of sickle-cell disease-related pain.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease

Outcome Measures

Primary Outcomes (1)

• Problematic use is abuse of or dependence on a substance according to the fourth edition of DSM (DSM-IV), and substance use disorder according to the fifth edition (DSM 5).

  The primary outcome mesure is evaluation of problematic use of EMONO. The DSM (Diagnostic and Satistical Manual) identifies 11 criteria for problematic use. The presence or absence of each criteria is assessed by phone with the patient. Therefore, the total number of criteria is calculated for each patient and represents the severity of problematic use.

  24 months after the start of the study

Interventions

telephone interview OTHER

Clinical assessment for screening and a phone call for questionnaire administration

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

French sickle-cell disease population who has a problematic use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and analgesics

You may qualify if:

• Subject with confirmed SCD diagnosis, regardless whether it is the homozygous or heterozygous form
• Subject treated for SCD at a RSCCA participating in the study, regardless of the duration of the illness
• Subject under the age of 26
• Written consent from adult subjects and written consent from one of the parents or legal guardians of minors

You may not qualify if:

• State-protected adult (under guardianship)
• Subject not having the general aptitude to participate in the study assessment (i.e. not able to respond to the telephone interview): too young, insufficient motor development, major difficulties understanding the French language and/or speech and/or hearing disorders

Sponsors & Collaborators

• Nantes University Hospital: lead
• University Hospital, Marseille: collaborator
• University Hospital, Clermont-Ferrand: collaborator
• University Hospital, Toulouse: collaborator
• University Hospital, Paris: collaborator
• University Hospital, Lille: collaborator

Related Publications (3)

• Gerardin M, Rousselet M, Couec ML, Masseau A; PHEDRE Group; Aquizerate A, Authier N, Deheul S, Roussin A, Micallef J, Djezzar S; French Addictovigilance Network (FAN); Feuillet F, Jolliet P, Grall-Bronnec M, Victorri-Vigneau C. Substance use disorder of equimolar oxygen-nitrous oxide mixture in French sickle-cell patients: results of the PHEDRE study. Orphanet J Rare Dis. 2024 Mar 18;19(1):124. doi: 10.1186/s13023-024-03133-w.

  PMID: 38500184 DERIVED

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Interviews as Topic

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

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

• Marie GERARDIN, Doctor

  Hospital practitioner

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 20, 2015
• Study Start: September 25, 2015
• Primary Completion: September 25, 2016
• Study Completion: December 31, 2017
• Last Updated: May 30, 2018

Record last verified: 2018-05