anxiety in recovering opiate dependence

Conditions: Generalized Anxiety Disorder; Comorbid Opiate Dependence in Remission; Status Post Methadone-Maintenance Treatment

Summary: this is a 16 week study of the efficacy of quetiapine in treating symptoms of generalized anxiety disorder (gad) in subjects with comorbid opiate dependence. the study will be conducted in a prospective, randomized, double-blind, and placebo-controlled fashion. study subjects will be inpatients at a residential drug-treatment facility, enrolled in a 1 year methadone-to-abstinence treatment plan. subjects will be randomized to receive either quetiapine or placebo in addition to ongoing drug addiction treatment. subjects will be followed for 16 weeks and a variety of psychometric assessments will be made. hypothesis one: compared to placebo, quetiapine will demonstrate a greater reduction in symptoms of anxiety in subjects with gad and remitted comorbid opiate abuse. exploratory hypotheses: compared to placebo, quetiapine will demonstrate a greater improvement in psychosocial functioning and compliance with community norms in subjects enrolled in a residential drug addiction treatment facility.


Eligibility criteria:
inclusion criteria: * provision of written informed consent * a diagnosis of opiate dependence as defined by diagnostic and statistical manual of mental disorders- fourth edition (dsm-iv) during the past two years. * a diagnosis of generalized anxiety disorder as defined by diagnostic and statistical manual of mental disorders- fourth edition (dsm-iv) within the past 6 months. * males and females aged 21-55 years * female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (hcg) test at enrollment * able to understand and comply with the requirements of the study * subjects must be free of illicit drug use for the past 3 months * subjects must have received methadone maintenance therapy for at least 3 months, and have been at least 2 weeks methadone-free * good health, as assessed by medical history, physical examination and laboratory tests exclusion criteria: * pregnancy or lactation * current diagnosis of any axis i disorder other than gad, substance dependence in remission, or nicotine dependence * patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others * known intolerance or lack of response to quetiapine fumarate, as judged by the investigator * use of any of the following cytochrome p450 3a4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir * use of any of the following cytochrome p450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, st. john's wort, and glucocorticoids * administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation * medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment * unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator * involvement in the planning and conduct of the study * previous enrollment or randomisation of treatment in the present study. * participation in another drug trial within 4 weeks prior enrollment into this study or longer in accordance with local requirements * a patient with diabetes mellitus (dm) fulfilling one of the following criteria: * unstable dm defined as enrollment glycosylated hemoglobin (hba1c) \>8.5%. * admitted to hospital for treatment of dm or dm related illness in past 12 weeks. * not under physician care for dm * physician responsible for patient's dm care has not indicated that patient's dm is controlled. * physician responsible for patient's dm care has not approved patient's participation in the study * has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. for thiazolidinediones (glitazones) this period should not be less than 8 weeks. * taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks note: if a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study. * an absolute neutrophil count (anc) of 1.5 x 109 per liter * positive urine drug screening test for drugs of abuse

Keywords: generalized anxiety disorder opiate dependence methadone-maintenance drug addiction treatment