A Multicenter Study Assessing the Prevalence of Co-addictions in Subjects Receiving Maintenance Treatment for Opiate Dependence. Determination of Clinical and Pharmacological Profil.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 7
- 主要终点
- Presence or absence of co-addictions (exept tobacco dependence)
研究概览
简要总结
The aim of this study is to determine the current prevalence of co-addictions, including problem/pathological gambling, in patients receiving Opiate Substitution Treatment (OST), and to then compare patients receiving OST with or without a co-addiction (excluding tobacco dependence) in order to determine their clinical profile.
In addition, an ancillary study to be carried out only among those patients receiving methadone, will aim to etablish whether a low plasma concentration of methadone, on the one hand, and an ultrarapid metabolizer genetic profile, on the other, are the characteristics most commonly associated with the presence of co-addictions. This will allow us to complete patient's pharmacological characterization.
详细描述
Non-interventionel study Total duration: 12 months (preparation, recruitment, analysis) Recruitment period: 6 months Duration of monitoring per patient: no monitoring
Main objective: to assess the current prevalence of addictive co-morbidities in opiate-dependent subjects receiving Opiate Substitution Treatment (OST) for at least 6 months.
Secondary objective: to compare patients being treated using OST who currently have a co-addiction (with the exception of tobacco dependence) with patients being treated with OST who do not currently have a co-addiction, based on pharmacological and clinical characteristics (for pharmacological characteristics: pharmacokinetic and pharmacogenetic analyses as part of an ancillary study into only those patients being treated with methadone).
Main judgment criterion: Presence or absence of co-addictions (except tobacco dependence), determined using assessment tools.
The secondary assessment criteria shall be: sociodemographic data, data about opiate dependence, data about other substance use disorders, data about gambling practice, psychopathological data (impulsivity, ADHD), pharmacokinetic data and pharmacogenetic data.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Under treatment unsing methadone or buprenorhine (+/- naloxone) or morphine as substitute, prescribed for opiate dependence,
- •OST begining at least 6 months previously,
- •Incarceration for less than a month in the event of monitoring in SMPR,
- •Good understanding of French, able to read and write.
- •General non-Inclusion Criteria:
- •Protected adults (guardianship, wardship)
- •Disorder of higher-order brains functions (severe cognitive disorders or confusion) or psychotic disorder (hallucinations, delusion) that may interfere with the study.
- •Non-Inclusion criteria for patients participating in the ancillary study:
- •Medical monitoring by a doctor from the Drug Addiction Network of the Nantes Area,
- •OST other than methadone
- •Adjustement to dosage in the 5 days prior to administering OST
- •Pregnant women
- •Absence of social security registration.
排除标准
- 未提供
结局指标
主要结局
Presence or absence of co-addictions (exept tobacco dependence)
时间窗: 1 day
Questionnaire
次要结局
未报告次要终点