Status:
TERMINATED
Anxiety in Recovering Opiate Dependence
Lead Sponsor:
Beth Israel Medical Center
Collaborating Sponsors:
AstraZeneca
Conditions:
Generalized Anxiety Disorder
Comorbid Opiate Dependence in Remission
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
Brief 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 prospecti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00668265
Start Date
January 1 2008
End Date
August 1 2011
Last Update
February 18 2013
Active Locations (1)
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1
Su Casa Methadone-to-Abstinence Rehabilitation
New York, New York, United States, 10002