Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
Buprenorphine soluble film
+ Placebo
+ Buprenorphine/naloxone film strip
Troubles liés aux narcotiques+2
+ Troubles Mentaux
+ Troubles liés aux opioïdes
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mars 2008
Date à laquelle le premier participant a commencé l'étude.Buprenorphine sublingual and buccal soluble films are being developed to be used for the same indication and over the same buprenorphine dose range as Subutex and Suboxone sublingual tablets in the treatment of opioid dependence. However, only films administered by the sublingual route were evaluated in this study. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Subutex and Suboxone product: * Mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format. * Improvement in subject convenience and compliance by ensuring rapid disintegration. * Protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting. * Provision of a unit dose product format for hospital and institutional use. * Decreased product damage during shipping as compared to Subutex and Suboxone tablets.
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.38 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
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 18 à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: Subject must: * Provide written informed consent. * Have a Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of opioid dependence. * Be male or female, 18 to 65 years of age, inclusive. * If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control. Exclusion Criteria: Subjects must not: * Have participated in an experimental drug or device study within the last 30 days. * Be currently (past 30 days from start of screening) engaged in opioid agonist, opioid partial agonist, or opioid antagonist treatment. * If female, be breast feeding or lactating. * Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study. * Have any clinically significant non-substance use psychiatric disorder (e.g., schizophrenia). * Have current suicidal ideation. * Have a Mini Mental Status Exam score less than 24. * Have physical dependence on alcohol. * Have physical dependence on sedative-hypnotics. * Have active aphthous stomatitis. * Have active oral herpes. * Need on-going prescription medications that interact with the P450 3A4 (a member of the cytochrome P450 superfamily of enzymes) system.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalObjectifs 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 1 site
Johns Hopkins University School of Medicine
Baltimore, United StatesOuvrir Johns Hopkins University School of Medicine dans Google Maps