protocolSection identificationModule nctId: NCT06266039, orgStudyIdInfo id: 2022-0328-01, secondaryIdInfos id: 2022-A02616-37, type: OTHER, domain: French National Agency for the Safety of Medicines (ANSM), briefTitle: Introduction of Long Acting Buprenorphine in France, acronym: OBAP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-31, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Bordeaux, class: OTHER, descriptionModule briefSummary: The current available pharmacological treatment formulations (i.e., daily formulations of buprenorphine or methadone) for OUD in France may have several inconveniences, such as: compliance, burden of daily intake, and risk of misuse; that may hinder their effectiveness. Long acting formulations of buprenorphine (LAB) such as Buvidal have been developed to favor retention and compliance and minimize the risk of diversion. Previous studies are promising on the advantage of LAB to treat opioid addiction, however more evidence is needed in the French healthcare context. However, in addition to randomized clinical trials, the French National Healthcare Agency (HAS "Haute Autorité de Santé") recommends conducting "real-life" studies (i.e., in naturalistic conditions) during the development of a medication and the use of "Patient Reported Outcome Measures" (PROMs) to analyze patient quality of life and/or other measures relevant to patients (e.g., severity, efficiency), without interpretation of the answers by a health professional. In this regard, our study proposes to use the Addiction Severity Index (ASI) self-report questions and several scales on treatment satisfaction and quality of life to collect the patient's opinion of perceived changes following the use of Buvidal.Main objectives:The objectives of this prospective open observational study, in naturalistic conditions, are to examine in individuals with an opioid use disorder, over a period of 6 months after LAB treatment initiation: the change in substance addiction severity and the changes in health-related quality of life, craving, opioids and other substance and non-substance uses and misuses, alcohol, tobacco and non-substance addiction severity, satisfaction with LAB treatment, severity of others domains related to addiction severity (i.e., medical, social, psychological) and psychiatric comorbiditiesMain hypotheses:1. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of the CS of "Drug use" (i.e., substance addiction severity) at 6 months compared to baseline.2. Hypothesize was that LAB will be associated with a stable (if prior remission) or a reduction of opioids and other substance and non-substance uses and misuses, other substances and non-substances addiction severity, craving, severity of others domains related to addiction (i.e., medical status, employment and support, family/social status, psychological status), an improvement of quality of life and a good satisfaction with treatment at follow-ups compared to baseline., conditionsModule conditions: Addiction Opiate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 223, type: ESTIMATED, outcomesModule primaryOutcomes measure: The change in the composite score of the "Drug use" section from the Addiction Severity Index (ASI) at 6 months after treatment initiation, secondaryOutcomes measure: The change in addiction severity at 6 months after treatment initiation, secondaryOutcomes measure: The change in quality of life with EuroQoL-5 Dimensions-5 Levels (EQ-5DL-5L) at 6 months after treatment initiation, secondaryOutcomes measure: The change in quality of life with the 12-Item Short Form Survey (SF-12) at 6 months after treatment initiation, secondaryOutcomes measure: The change in quality of life with nottingham health profile part 1 and part 2 (NHP1 and NHP2) at 6 months after treatment initiation, secondaryOutcomes measure: The change in quality of life with assisted quality of life assessment chart (TEAQV) at 6 months after treatment initiation, secondaryOutcomes measure: The change in other use at 6 months after treatment initiation, secondaryOutcomes measure: The change in craving at 6 months after treatment initiation, secondaryOutcomes measure: The change in other domains of addiction severity at 6 months after treatment initiation, secondaryOutcomes measure: The change in Treatment Satisfaction Questionnaire for Medication (TSQM) at 6 months after treatment initiation, secondaryOutcomes measure: Cues - craving - use links and others factors variations measure with EMA after treatment initiation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bordeaux, status: RECRUITING, city: Bordeaux, state: Gironde, zip: 33000, country: France, contacts name: Marc Auriacombe, Professor, role: CONTACT, phone: +33556561738, email: marc.auriacombe@u-bordeaux.fr, geoPoint lat: 44.84044, lon: -0.5805, hasResults: False