Cannabis use and dependence among festival attendees: results from the French OCTOPUS survey.

BACKGROUND: Chronic use of cannabis is associated with an increased risk of psychosocial, mental and physical health impairments. Sociohealth institutions reach a very limited proportion of cannabis users in need of treatment. Using data collected from festival attendees, this study aimed to estimate the prevalence of dependent cannabis users and to characterize cannabis dependence. METHODS: We used data from the cross-sectional OCTOPUS survey carried out at 13 music events in the French department of Loire-Atlantique between July 2017 and July 2018. 383 participants aged 18 or older underwent a face-to-face interview about their basic sociodemographics, tobacco use, alcohol use and past-year substance use. Using the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria, we estimated the prevalence of dependent cannabis users and characterized their dependence. RESULTS: More than two-thirds of participants reported that they had used cannabis in the past 12 months. Among 194 regular cannabis users (at least monthly), 63.4% were dependent. At least 40% of regular users reported health and/or social consequences of cannabis use. Compared to nondependent cannabis users, dependent cannabis users were more likely to be stimulant users and hallucinogen users. CONCLUSIONS: Dependent cannabis use is common among festival attendees, especially among stimulant or hallucinogen users. Festival settings may be important arenas for i) implementing efficient harm reduction measures to prevent dependence and ii) providing information on care structures and promoting the use of care to dependent users. In addition, healthcare professionals should be aware of trends in polysubstance use among dependent cannabis users.

Substance use disorder of equimolar oxygen-nitrous oxide mixture in French sickle-cell patients: results of the PHEDRE study.

BACKGROUND: In many countries, nitrous oxide is used in a gas mixture (EMONO) for short-term analgesia. Cases of addiction, with significant misuse, have been reported in hospitalized patients. Patients suffering from sickle cell disease (SCD) could represent a high-risk population for substance use disorder (SUD) due to their significant pain crisis and repeated use of EMONO. The objective of the PHEDRE study was to assess the prevalence of SUD for EMONO in French SCD patients. RESULTS: A total of 993 patients were included. Among 339 EMONO consumers, only 38 (11%) had a SUD, with very few criteria, corresponding mainly to a mild SUD due to a use higher than expected (in quantity or duration) and relational tensions with the care teams. Almost all patients (99.7%) were looking for an analgesic effect, but 68% of patients were also looking for other effects. The independent risks factors associated with at least one SUD criterion were: the feeling of effects different from the expected therapeutic effects of EMONO, at least one hospitalization for vaso occlusive crisis in the past 12 months and the presence of a SUD for at least one other analgesic drug. CONCLUSIONS: The use of EMONO was not problematic for the majority of patients. Manifestations of SUD that led to tensions with healthcare teams should alert and lead to an evaluation, to distinguish a true addiction from a pseudoaddiction which may be linked to an insufficient analgesic treatment related to an underestimation of pain in SCD patients. TRIAL REGISTRATION: Clinical Trials, NCT02580565. Registered 16 October 2015, https://clinicaltrials.gov/.

"Naloxone? Not for me!" First cross-assessment by patients and healthcare professionals of the risk of opioid overdose.

BACKGROUND: Opioid-related mortality is a rising public health concern in France, where opioids were in 2021 implicated in 75% of overdose deaths. Opioid substitution treatment (OST) was implicated in almost half of deaths related to substance and drug abuse. Although naloxone could prevent 80% of these deaths, there are a number of barriers to the distribution of take-home naloxone (THN) among opioid users in France. This study is the first one which compares patients' self-assessment of the risk of future opioid overdose with the hetero-assessment provided by healthcare professionals in a population of individuals eligible for naloxone. METHODS: This was a multicenter descriptive observational study carried out in pharmacies across the Pays de la Loire region (France) during April and May 2022. All adult patients who visited a participating pharmacy for a prescription of OST and provided oral informed consent were enrolled in the study. Retrospective data were collected through cross-sectional interviews conducted by the pharmacist with the patient, utilizing an ad hoc questionnaire. The patient's self-assessment of overdose risk was evaluated using a Likert scale from 0 to 10. The pharmacist relied on the presence or absence of overdose risk situations defined by the French Health Authority (HAS). The need to hold THN was assessed using a composite criterion. RESULTS: A total of 34 patients were interviewed; near one third were aware of the existence of THN and a minority had THN in their possession. Out of the 34 participants, 29 assessed their own risk of future opioid overdose: 65.5% reported having zero risk, while 6.9% believed they had a high risk. Nevertheless, at least one risk situation of opioid overdose was identified according to HAS criteria in 73.5% of the participants (n = 25). Consequently, 55% of the participants underestimated their risk of experiencing a future opioid overdose. Yet, dispensing THN has been judged necessary for 88.2% of the participants. CONCLUSION: This study underscored the imperative need to inform not only healthcare professionals but also the patients and users themselves on the availability of THN and the risk situations of opioid overdose.

French national addictovigilance follow-up of zolpidem between 2014 and 2020: evolution of drug abuse, misuse and dependence before and after the regulatory change.

BACKGROUND: Since the appearance of zolpidem on the market, the occurrence of serious cases of abuse, misuse and dependence have come to the attention of authorities. In view of the increase in the number and severity of cases among zolpidem users and the predominant presence of zolpidem in falsified prescriptions, the French Health Authorities implemented part of the narcotics regulation for zolpidem in April 2017. The objective of this article was to describe the evolution of the abuse, dependence and misuse of zolpidem. METHODS: We used three data sources: (i) zolpidem is a reimbursable and strictly prescription drug in France. Medic'AM is a public database that indicates the number of tablets reimbursed each month in France for each reimbursable drug. This database has been analyzed as a proxy of the exposure of the French population to zolpidem; (ii) all French cases of drug dependence or abuse reported by health professionals (regulatory obligation) and (iii) an epidemiological tool based on the surveillance of falsified prescriptions over two periods: the 3-year period before the regulatory measure (2014-16) and the 3-year period after the regulatory measure (2018-20). RESULTS: This regulatory change had two immediate consequences: a sharp decline in falsified prescriptions and a decrease of ∼57% between the two study periods in the zolpidem reimbursement data. Markers of problematic consumption remained after the regulatory change with worsening cases, particularly for people who were genuinely dependent and/or had comorbidities or misusers for whom zolpidem was the substance of interest, whose proportion increased significantly in the addictovigilance notification system, from 43.6% (N = 107) to 59.3% (N = 127) (P < 0.01). CONCLUSIONS: Further monitoring is needed in light of these persistent markers of problematic consumption.

Is history of abuse predictive of eating disorders with binge-eating episodes through an effect mediated by impulsivity? A French longitudinal study.

BACKGROUND: In recent years, many studies have explored the associations among impulsivity, history of abuse, the emergence of eating disorders with episodes of binge eating (EDBE) and their severity. Nevertheless, factors associated with successful clinical outcomes of EDBE are still unknown. Our study aimed to test the hypothesis that a history of abuse is associated with unsuccessful clinical outcomes of EDBE through an effect mediated by impulsivity. METHODS: We assessed patients older than 15 years, 3 months with EDBE at inclusion and at 1 year. Recovery was defined as the absence of eating disorders at 1 year. A mediation analysis was performed by means of structural equation modelling. RESULTS: We included 186 patients in our analyses (54% bulimia nervosa, 29% anorexia nervosa binge eating/purging type and 17% binge-eating disorder); 179 (96%) were female. One-third (n = 63) of patients reported a history of abuse, and recovery was observed for 20% of the sample (n = 38). Contrary to our assumption, a history of abuse was not associated with the absence of recovery of EDBE at 1 year. Factors unfavourable for achieving recovery were anxiety disorders (odds ratio [OR] 0.41), vomiting (OR 0.39), physical hyperactivity (OR 0.29), negative urgency and a lack of perseverance (OR 0.85 for both). Only positive urgency was positively associated with recovery (OR 1.25). LIMITATIONS: We excluded 219 patients lost to the 1-year follow-up. CONCLUSION: Our findings may help to deconstruct the empirical belief that traumatic events may interfere with the successful course of treatment for eating disorders. A high level of positive urgency may be associated with more receptivity to care.

Did the New French Regulation of Zolpidem Decrease the Problematic Consumption of Zolpidem? A Field Study among Users.

Background: The French national drug regulatory authority stated, in 2017, that a secured prescription pad must be used for zolpidem prescriptions. This study aimed to evaluate the evolution of the problematic consumption of zolpidem at the individual level since the new regulation. Methods: Two nationwide populations of at-risk users of zolpidem were recruited: one in general practitioner (GP) offices and one in specialized care centers dedicated to drug dependence (SCDDs). Participants were asked about their zolpidem consumption before and after the regulation change. The primary outcome was the evolution of problematic zolpidem consumption, as defined by at least one of the following criteria: overconsumption, fraudulent ways of obtaining, effects sought other than hypnotic, and modes of administration other than oral. Results: A total of 243 participants were included: 125 from GP offices and 118 from SCDDs. In the GP population, the prevalence of patients who were identified as problematic consumers decreased from 24.8% to 20.8% (p = 0.593), whereas the prevalence decreased from 73.7% to 51.7% in the SCDD population (p < 0.001). The most prevalent criteria for problematic status were overconsumption and fraudulent ways. Conclusions: The new French regulation of zolpidem had different impacts among two different populations of at-risk zolpidem consumers.

Did the pattern of use of zolpidem change since the enforcement of a new prescription rule? A latent class analysis using the French health insurance database.

BACKGROUND: In recent years, zolpidem has been the subject of numerous reports of misuse, abuse and dependence. In view of these risks, the French drug agency decreed the implementation of secure prescription pads in April, 2017. The objective of this study was to characterize the impact of this regulatory change on the patterns of zolpidem use. RESEARCH DESIGN AND METHODS: We included patients with at least one reimbursement for zolpidem before and/or after the regulatory change using a sample of the French health insurance database. For each period, we identified profiles of users using a latent class analysis (LCA). RESULTS: In total, 15,550 zolpidem users were identified before the measure and 8,301 after the measure. We identified the same three profiles of zolpidem users before and after the measure: non-problematic users (the most prevalent), users whose drug prescriptions suggest psychiatric disorder and potential problematic users. The profile of potential problematic users was similar after the regulatory change but represented a lower absolute number of patients. CONCLUSION: In conclusion, the regulatory change had a positive impact on the patterns of zolpidem use, but the impact should be reevaluated, because withdrawal can take a long time, especially in long-term users. TRIAL REGISTRATION: The study was registered at www.clinicaltrials.gov under the reference number NCT03584542.

Are marked body shape concerns associated with poorer outcomes at the one-year follow-up in anorexia nervosa?

OBJECTIVE: Anorexia nervosa (AN) is a complex disease in which obsessive thoughts about body image, shape, or weight are expressed. The intensity of these concerns varies among individuals, and only a few studies have focused on their impact on patients' clinical course when patients are treated on an outpatient basis. Our study aimed to determine whether marked body concerns at inclusion were predictive of the one-year follow-up. METHOD: Participants (N = 72) were women seeking treatment for AN in a specialized unit for eating disorder management. All participants were assessed at inclusion and at the 1-year follow-up. Clinical outcome was assessed using the Morgan & Russel Outcome Average Score (MROAS), and body concerns were assessed using the Body Shape Questionnaires (BSQ). RESULTS: Marked body concerns (BSQ score >140) at inclusion were associated with a poorer outcome at the 12-month follow-up (lower MROAS "total score"). Other characteristics at inclusion that were predictive of a poorer outcome at 12 months were as follows: higher severity of ED at inclusion, longer hospitalization during follow-up, and experiencing a lower impact of the illness on school/work life. DISCUSSION: The results confirmed the importance of a multifocal treatment that should address body concerns and motivation to change. Our results also highlighted the necessity of promoting the maintenance of school/work during the treatment course.

Descriptive analysis of sickle cell patients living in France: The PHEDRE cross-sectional study.

BACKGROUND: Sickle cell disease (SCD) induces chronic haemolytic anaemia and intermittent vaso-occlusion that results in tissue ischaemia causing acute, severe pain episodes that can lead to frequent hospitalizations. These consequences can have repercussions on family, social, school and/or professional life. Here, we present some of the results of the PHEDRE study (Pharmacodépendance Et DREpanocytose-drug dependence and sickle-cell disease), which is the largest study of patients with SCD in France. This paper intends to describe characteristics of the French SCD population. We also aimed to assess the impact of the disease on the lives of patients using objective and subjective variables. METHODS: The PHEDRE study was a national multicentric observational study. Adults, adolescents and children with a confirmed SCD diagnosis were included in the study by their referring doctor. Then, they were interviewed by phone about their socioeconomic status, about the impact of the disease on their lives and about their analgesic and psychoactive drug use. RESULTS: The study population consisted of 872 patients (28% were minors). Seventy-two percent of adults were active, and all minors were in school. Many patients presented criteria of severe SCD. Seventy-five percent were homozygous SS, 15% were double heterozygotes SC and 8% were heterozygotes Sßthal, 87% received specific treatment, 58% were hospitalized at least once for vaso-occlusive crisis in the past 12 months, and the number of analgesic drugs taken averaged 3.8. Seventy-five percent of patients reported academic or professional consequences related to their SCD, and 52% reported social consequences. CONCLUSIONS: The impact of SCD on patients' lives can be significant, nevertheless their social integration seems to be maintained. We highlighted respect of recommendations regarding analgesic treatments and only a few patients used tobacco, alcohol or cannabis. TRIAL REGISTRATION: Clinical Trials, NCT02580565; https://clinicaltrials.gov/ Registered 16 October 2015.

Change in the regulatory framework for zolpidem: What is the impact on the landscape of the prescription of sedative medications? The French national ZORRO study.

AIMS: In recent years, zolpidem has been the subject of numerous reports of misuse, abuse and dependence. In view of these risks, the French drug agency (ANSM) decreed in April 2017 the implementation of secure prescription pads. The objective of this study was to evaluate the impact of this regulatory measure on the prescription of zolpidem and other sedative medications (zopiclone, benzodiazepines and antihistamines) in long-term users of zolpidem and associated factors. METHODS: We performed a historical cohort study using data from the Generalist Sample of Beneficiaries (EGB). All patients aged over 18 years old who were long-term users (at least 3 months) before the measure were enacted. We analysed the reimbursement trajectories of zolpidem, zopiclone, benzodiazepines and antihistamines (hydroxyzine and alimemazine) up to 2 years after the measure using a state sequence analysis. RESULTS: Overall, 2502 patients were analysed. A four-cluster typology was identified: continuation of zolpidem (n = 1044, 42%), discontinuation of sedative medications (n = 766, 31%), change to zopiclone (n = 537, 21%) and change to hypnotic benzodiazepines (n = 155, 6%). The most frequently prescribed hypnotic benzodiazepine was lormetazepam. We identified age, sex, treatment for psychiatric or addictive disorder and volume of zolpidem use before the measure as factors associated with different reimbursement trajectories after the regulatory change. CONCLUSION: The regulatory change for zolpidem prescriptions reduced exposure to zolpidem among long-term users and also had a broad impact on prescriptions of other sedative medications. Switching to other medications that also present a potential risk of abuse or dependence should be carefully monitored.

Benzodiazepine withdrawal in older people: what is the prevalence, what are the signs, and which patients?

PURPOSE: Benzodiazepines (BZDs) and related drugs (Z-drugs) are mainly taken chronically, and older people are much more likely to take them on a chronic basis despite recommendations. Withdrawal symptoms could be an obstacle to stopping BZD/Z-drug administration. The main objective of this study is to estimate the prevalence of withdrawal symptoms in patients aged 65 years and older who have experience a stop of BZD/Z-drug. The secondary objectives are to describe the withdrawal symptoms and identify factors associated. METHOD: This ancillary study was based on a national observational study in patients with chronic BZD/Z-drug consumption. Patients who made at least one BZD/Z-drug stop experience were selected. Withdrawal symptoms are described, and a logistic regression was carried out to identify the variables most associated with withdrawal symptoms. RESULTS: In total, 697 patients were selected: 78% experienced at least one withdrawal symptom after a stop administering BZDs or Z-drugs; most of the withdrawal symptoms were psychological disorders. CONCLUSION: Our study identifies a specific population experiencing withdrawal symptoms and who cannot stop administering BZD/Z-drug. We assume that withdrawal symptoms in patients with chronic use play an essential role in the nonstop use of BZD/Z-drugs.

Are Seniors Dependent on Benzodiazepines? A National Clinical Survey of Substance Use Disorder.

Benzodiazepines and Z-drugs, zolpidem and zopiclone, (BZD/Z) are used longer than recommended in the elderly population. However, to date, very few attempts have been made to evaluate dependence on BDZ/Z among the elderly population. We conducted a national multicentric observational prospective study aimed at evaluating the prevalence of and risk factors for dependence among elderly adults. Patients aged 65 or older who were treated with BZD/Z for at least 3 months were evaluated through clinical interviews that conformed to official Diagnostic and Statistical Manual of Mental Disorders (DSM) dependence criteria. Among the 1,024 patients included in the survey, 442 of 976 (45.3%) met the dependence criteria. In the multivariate logistic regression model, dependent patients were categorized as follows: younger (odds ratio (OR) = 0.97), living mostly alone (OR = 1.45), showing psychiatric problems (OR = 2.22), having additional treatments (other than BZD/Z; OR = 1.37), having long-lasting treatment (OR = 1.04), exhibiting significant relationship difficulties (OR = 1.96), committing transgressional behaviors to procure BZD/Z (OR = 2.70), and wanting to stop their consumption of BZD/Z (OR = 7.60). A latent class analysis, which was applied to sort out subgroups within dependent patients, identified two profiles according to the prevalence of dependence items: profile 1 (73%), "withdrawal syndrome when BZD/Z is stopped" (100%) and "previous unsuccessful attempts to stop consumption" (82%); and profile 2 (27%), "tolerance" (76%) and "intake in larger amounts or over a longer period than intended" (86%). BZD/Z dependence is frequent in the elderly population, and among dependent patients, we found two profiles corresponding to positive and negative conditioning of the psychoactive effects of BZD/Z. This study is registered as NCT01920581.

Food Addiction among Female Patients Seeking Treatment for an Eating Disorder: Prevalence and Associated Factors.

The concept of "food addiction" (FA) has aroused much focus because of evidence for similarities between overeating and substance use disorders (SUDs). However, few studies have explored this concept among the broad spectrum of eating disorders (ED), especially in anorexia nervosa (AN). This study aimed to assess FA prevalence in ED female patients and to determine its associated factors. We recruited a total of 195 adult women with EDs from an ED treatment center. The prevalence of FA diagnosis (Yale Food Addiction Scale) in the whole ED sample was 83.6%; AN restrictive type (AN-R), 61.5%; AN binge-eating/purging type (AN-BP), 87.9%; bulimia nervosa (BN), 97.6%; and binge-eating disorder (BED), 93.3%. The most frequently met criteria of FA were "clinically significant impairment or distress in relation to food", "craving" and "persistent desire or repeated unsuccessful attempts to cut down". An FA diagnosis was independently associated with three variables: presence of recurrent episodes of binge eating, ED severity, and lower interoceptive awareness. In showing an overlap between ED and FA, this study allows for considering EDs, and AN-R in particular, from an "addictive point of view", and thus for designing therapeutic management that draws from those proposed for addictive disorders.

Do older people know why they take benzodiazepines? A national French cross-sectional survey of long-term consumers.

OBJECTIVES: Benzodiazepines and non-benzodiazepine hypnotics (or Z-drugs) (BZD/Z) are widely prescribed for older patients despite major side effects and risks when chronically used. The patient's understanding of the treatment is one of the keys to good adherence. The purpose of the study was to assess the knowledge of BZD/Z treatment among older people who were taking BZD/Z for the long term by studying the concordance between the declared reason for taking BZD/Z and its indication. METHODS: This was a cross-sectional, pharmacoepidemiologic ancillary of a national study. Data were collected through a semi-structured interview. All patients from the main study were included. "Good knowledge" was considered when patients gave an indication for each BZD/Z that was similar to its marketing authorisation. Univariate and multivariate analyses were carried out to adequately determine profiles and characterise associations. RESULTS: More than half of the patients (61.6%) had a good knowledge regarding their treatment. The presence of a psychiatric disorder, a mean duration of BZD/Z use of less than 120 months, a desire to stop treatment, educational status and number and type of BZD/Z used were significantly associated (P < .05) with good knowledge. In the multivariate analysis, only a psychiatric disorder, educational status and taking at least one hypnotic drug were associated with good knowledge. CONCLUSIONS: At the time of shared medical decision, it appears essential to improve the knowledge of the treatment by the patient. The rate of patients with good knowledge of their BZD/Z treatment remains low and even lower than what was previously found in the literature for other drug classes. In contrast to patients with good knowledge, these data highlight the characteristics of patients with poor knowledge of their BZD/Z treatment, which may allow populations at risk to be targeted and enable education measures to be strengthened.

Prevalence of zolpidem use in France halved after secure prescription pads implementation in 2017: A SNDS database nested cohort study.

Our objective was to quantify the impact on the use of zolpidem of the obligation implemented in France in 2017 to use secure prescription pads to prescribe it. We conducted a cohort study within the French SNDS healthcare database. Patients aged over 18 years of age were considered for inclusion. The number of prevalent users and incident episodes of zolpidem use were compared before the change in law (July 1, 2016 to January 1, 2017) and after (July 1, 2017 to January 1, 2018). A prevalent user was a patient who has been reimbursed for zolpidem at least once. An incident episode of zolpidem use was defined by a first administration of zolpidem without any prior administration within the previous six months. Regarding prevalence of zolpidem users, we observed a decrease from 2.79% (CI95%:2.75-2.83) to 1.48% (1.44-1.51), with a number of patients who stopped taking it after the change in law being approximately 4.3 times higher than the number of patients who started. We observed a negative association between the post-law change period (OR = 0.52 (0.51-0.53)) and the probability of receiving zolpidem, adjusting for sex, aging, low income and chronic disease. We observed a decrease from 183 treatment episodes per 100,000 insured months on average to 79 episodes per 100,000 insured months, with an incidence rate ratio (IRR) equal to 0.43 (0.38-0.49). The use of secure prescription pads seems to have reduced the exposure of the French population to zolpidem.

Consumption of psychoactive substances in prison: Between initiation and improvement, what trajectories occur after incarceration? COSMOS study data.

BACKGROUND: Few studies have examined the consumption trajectories of inmates after entry to prison. The aim of this study was to assess the changes in the consumption of psychoactive substance between the period before detention and during incarceration and to characterize the profiles of prisoners with similar consumption trajectories during incarceration. METHODS AND FINDINGS: A multicenter, cross-sectional study was performed in all of the prisons from one region of France. All prisoners incarcerated during their 3rd months, over 18 years old, and with a sufficient level of French fluency to participate in the study were recruited over a period of 12 months. A total of 800 prisoners were recruited. All prisoners were interviewed face-to-face by a trained interviewer. A majority of prisoners had used at least one psychoactive substance in the weeks prior to incarceration. During incarceration, a substantial reduction in alcohol and illicit drug consumption was observed. The initiation of consumption and an increase in consumption were primarily related to medications. Five different profiles of consumption before incarceration were identified. These profiles all had a high probability of migrating to a similar profile during detention, characterized by less severe consumption of psychoactive substances. CONCLUSIONS: Based on their consumption profile prior to incarceration, most prisoners would benefit from a specific medical evaluation as soon as possible following entry into detention. Prison could be an opportunity for reduced consumption and/or the initiation of treatment for the majority of prisoners, despite the pejorative development observed for a minority of prisoners during incarceration.

French national health insurance database analysis and field study focusing on the impact of secure prescription pads on zolpidem consumption and sedative drug misuse: ZORRO study protocol.

INTRODUCTION: In recent years, data collected by the French Addictovigilance Network have shown the potential for abuse and addiction associated with zolpidem (the most sold hypnotic drug in France). Since 10 April 2017, new regulations have come into force that require zolpidem to be prescribed on special secure prescription pads, in order to reduce the risk of abuse or misuse. This measure has far-reaching repercussions that are not only limited to the consumption of zolpidem but also extend to the usage of sedative medication on a whole. The objective of the ZOlpidem and the Reinforcement of the Regulation of prescription Orders (ZORRO) study is to evaluate the overall impact of the new regulatory framework requiring zolpidem to be prescribed on special secure prescription pads. Three axes will be evaluated: the number of consumers, the type of consumption (chronic use versus occasional use, problematic consumption versus non-problematic use) and the consumption of other sedative molecules.The study has been registered in the Protocol Registration and Results System under the number NCT03584542 at stage "Pre-results". METHODS AND ANALYSIS: The ZORRO study is an epidemiological, observational, national multicentre, non-controlled, prospective research project supported by the French National Agency for Medicines and Health Products Safety. The evaluation of the impact of the regulatory framework change relative to zolpidem will be done according to two axes: via an epidemiological study of the French National Health Insurance database and by the implementation of field studies of prescribers and consumers of zolpidem. ETHICS AND DISSEMINATION: The Nantes Research Ethics Committee (Groupe Nantais d'Ethique dans le Domaine de la Santé), the Committee for the Protection of the Population and the Committee of Expertise in Research, Studies and Evaluations in the Field of Health approved this study. Results will be presented in national and international conferences and submitted to peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT03584542; Pre-results.

The MEOPAeDent trial protocol-an observational study of the Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) effects in paediatric dentistry.

BACKGROUND: Many studies were conducted to assess the benefit/risk ratio of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) in France before it was authorized for use outside the hospital setting in 2009. The main objective of this project is to evaluate the effects sought and felt by children when EMONO is used in paediatric dentistry. The secondary objectives are to (i) evaluate the appreciation of EMONO by the children, (ii) characterize children who experience both analgesia and anxiolysis, (iii) evaluate children's appetite for EMONO and characterize children with a high appetite and (iv) evaluate the impact of the difference in practice among the French dental service university hospitals on anxiety. The maintenance of a framework for the safe use of this drug, whose place in dental care is fundamental, is essential. Twelve of the 16 French dental service university hospitals agreed to participate in this study. METHODS: MEOPAeDent is an observational, descriptive, transversal study that aims to evaluate the effects sought and felt by children when EMONO is used in paediatric dentistry. Subjects requiring dental care under EMONO are recruited by 12 French dental service university hospitals. Patients aged from 3 to 15 years are recruited for the study when they visit a dental service of a French university hospital requiring dental care under EMONO. The investigator collects the necessary data from the child's medical records, from his own observations and from questions posed to the child and his/her parents. A survey is completed at the first and final sessions of dental care under EMONO. DISCUSSION: This study will provide an evaluation of the effects of EMONO on the French paediatric population in need of dental care as well as evaluate the appetite for the use of this substance. The results will first be used to provide additional data that is essential to monitor the use of a product with an authorization to use it outside of hospitals from 2009 in France, confirm its safety for use and justify its framework of application. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03453411 registered 2 March 2018.

Assessment of an Equimolar Mixture of Oxygen and Nitrous Oxide: Effects in Pediatric Dentistry.

BACKGROUND: Many studies were conducted to assess the benefit/risk of equimolar mixture of oxygen and nitrous oxide (EMONO), but evaluating the appetite associated to its use is now getting very little attention in the literature. The purpose of this study was to investigate the effects present, felt, and sought during care by the child related with the 50% nitrous oxide/oxygen (EMONO) sedation used in pediatric dentistry. MATERIALS AND METHODS: All patients in consultation with the Dental Service of Nantes hospital and in need of EMONO were included in the study. In this prospective single-center study, the effects present, felt, and sought during care by the child and the assessment of EMONO appreciation were recorded. The presence of clear signs that the child was trying to extend the duration of the EMONO use was also sought. RESULTS: Only 62% of the patients were presented with an anxiolytic effect, and 40% relative analgesia. Both effects were associated in 33% of children. Over the 76 patients assessed, 12 attempted to extend the duration of the EMONO use (16%). After a bivariate statistical analysis, none of the variables appeared significantly associated with the extension of the EMONO use duration. CONCLUSION: The significant proportion of patients who have prolonged the EMONO use seems to indicate a real attraction for nitrous oxide. This is the first study to evaluate nitrous oxide appreciation on a child. HOW TO CITE THIS ARTICLE: Prud'homme T, Allio A, Dajean-Trutaud S, et al. Assessment of an Equimolar Mixture of Oxygen and Nitrous Oxide: Effects in Pediatric Dentistry. Int J Clin Pediatr Dent 2019;12(5):429-436.

Typology of patients with behavioral addictions or eating disorders during a one-year period of care: Exploring similarities of trajectory using growth mixture modeling coupled with latent class analysis.

OBJECTIVES: Addictions are not restricted to substance-use disorders, and it is now widely recognized that they also include behavioral addictions. Certain individuals with eating disorders also experiment their disorder as an addiction. The objective was to identify typologies of patients presenting with various behavioral addictions or eating disorders according to their evolution within the framework of care, and to specify the factors associated with the differential clinical trajectories. METHODS: We included 302 patients presenting with problem gambling, sexual addiction, compulsive buying, excessive videogame use or eating disorders. The patients completed a multiaxial assessment through a face-to-face structured interview and self-administered questionnaires, including sociodemographic and addiction-related characteristics, psychiatric and addictive comorbidities and several psychological characteristics. The assessment was performed at inclusion and then repeated after 6 and 12 months. The statistical analysis included a combination of growth mixture models and latent class analysis. RESULTS: We identified five classes of patients with different profiles related to their trajectories during a one-year period of specialized care: "complex patients", "patients with impulsive psychological functioning", "patients with cooperative psychological functioning", "patients with immature psychological functioning," and "patients with resilient psychological functioning". CONCLUSIONS: The typology obtained brings interesting findings to propose patient-centered care strategies adapted to these disorders. Because the typology was independent from the type of disorder, it supports the general concept of behavioral addictions, and the similarities between eating disorders and behavioral addictions. The relevance of this model should be further examined in future studies.