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View Clinical Trial (Medical Research Study)
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Anxiety in Recovering Opiate Dependence - NCT00668265-10002 (Clinical Trial 218138)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy218138.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10002 |
| Conditions: |
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Generalized Anxiety Disorder - Comorbid Opiate Dependence in Remission - Status Post Methadone-Maintenance Treatment |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Su Casa Methadone-to-Abstinence Rehabilitation
New York, NY 10002
United States
Primary Contact:
Kevin Garvey, CASAC
Email: kgarvey@lesc.org
Phone: 212-566-3513
Secondary Contact:
James M Prosser, M.D.
Email: jprosser@chpnet.org
Phone: 212-844-1422 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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