Pharmacogenomics Study of Sleep Disturbance and Neurocognitive Impairments in the Opioid Addicts
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveTroubles liés aux narcotiques+3
+ Troubles Mentaux
+ Troubles liés aux opioïdes
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 1 mars 2009
Date à laquelle le premier participant a commencé l'étude.Opioid abuse is a complex problem, which not only impacts on addicts' physical and psychological health individually, but also threats the society. Recently, spread of HIV via sexual behavior and needle sharing among injecting drug users (IDUs) also becomes a serious public health problem all over the world. In Taiwan, since the first HIV-infected IDU identified in 1987, the incident cases have mounted to 2,461 in 2005. To prevent the epidemics of HIV among IDUs, the Center for Disease Control (CDC) thus collaborated with Department of Justice and implemented harm reduction programs in 2005. It is the milestone that opioid addiction is officially treated as a health rather than a legal issue in Taiwan. Among the harm reduction programs of needle and syringe exchange for IDUs as well as substitution treatment for opioid dependence, methadone maintenance treatment (MMT) is one of the most important parts. Till 2008, there were over 13,000 heroin addicts participated in more than 80 MMT programs. Although the clinical evidences have proven the superior effectiveness of maintenance therapy in ameliorating illicit substances abuse, decreasing criminality and improving quality of life, there are common problems of sleep disturbance and neurocognitive impairments among the subjects receiving opioid medications. The concerns of the adverse effects might thus frustrate the subjects' motivation and compliance to maintain treatments. However, sleep disturbance and neurocognitive impairments related to opioid medications are often neglected in the clinical practices and there are scanty researches focusing on these crucial issues in the existing literature. In this prospective study, four groups of subjects including methadone maintenance treatment, buprenorphine/naloxone, medication-free opioid ex-addicts and healthy volunteers will be enrolled. Via the comprehensive assessments including clinical interview, neurocognitive examinations, electrocardiogram-based sleep breathing detector and pharmacogenomical evaluation, we will not only have the opportunities to have more insights on the impacts of opioid medications on sleep and neurocognitive performances, but also develop more adequate strategies to improve motivation and outcome in treating the opioid addicts.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.340 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 20 à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Normal control group (NC): Inclusion criteria: Chinese ethnicity Men or women above age of 20 Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects) Individuals who have completed a written consent form Exclusion criteria: Patients with comorbid severe mental disorders including: Organic mental disorders, or Schizophrenia Past diagnosis of Heroin dependence by DSM-IV definition Severe cognitive impairment Being pregnant Methadone maintenance treatment group (MMT) Inclusion criteria: Chinese ethnicity Men or women above age of 20, below age of 65 Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects) Diagnosis of Heroin dependence by DSM-IV definition Enter methadone maintenance therapy for at least 3 months No change of methadone dosage for the last week Regularly took methadone for the last week Individuals who have completed a written consent form Exclusion criteria: Patients with comorbid severe mental disorders including: Organic mental disorders, or Schizophrenia Severe cognitive impairment Being pregnant Buprenorphine/Naloxone treatment group (BNT) Inclusion criteria: Chinese ethnicity Men or women above age of 20, below age of 65 Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects) Diagnosis of Heroin dependence by DSM-IV definition Enter buprenorphine maintenance therapy for at least 3 months No change of buprenorphine dosage for the last week Regularly took buprenorphine for the last week Individuals who have completed a written consent form Exclusion criteria: Patients with comorbid severe mental disorders including: Organic mental disorders, or Schizophrenia Severe cognitive impairment Being pregnant Medication-free ex-addict group (MF) Inclusion criteria: Chinese ethnicity Men or women above age of 20 Able to participate in a clinical assessment in Chinese (including Mandarin and Taiwanese dialects) Diagnosis of Heroin dependence by DSM-IV definition Individuals who have completed a written consent form Exclusion criteria: Patients with comorbid severe mental disorders including: Organic mental disorders, or Schizophrenia Severe cognitive impairment Being pregnant Exposure of methadone, buprenorphine and other opioid treatment in the previous 3 months
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.4 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 5 sites
Far Eastern Memorial Hospital
Banqiao District, TaiwanFar Eastern Memorial Hospital
Banqiao District, TaiwanEn-Chu-Gong Hospital
Sanxia District, Taiwan