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| Sponsor: | Beth Israel Medical Center |
|---|---|
| Collaborator: |
AstraZeneca |
| Information provided by: | Beth Israel Medical Center |
| ClinicalTrials.gov Identifier: | NCT00668265 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Generalized Anxiety Disorder Comorbid Opiate Dependence in Remission Status Post Methadone-Maintenance Treatment |
Drug: Quetiapine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Prospective, Sixteen-Week, Double-Blind, Placebo-Controlled, Trial of Seroquel in Combination With Treatment as Usual in Patients With GAD and Remitted Comorbid Opiate Dependence |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Su Casa Methadone-to-Abstinence Rehabilitation | |
| New York, New York, United States, 10002 | |
| Principal Investigator: | Sean Chappin, M.D. | Beth Israel Medical Center |
More Information
| Responsible Party: | Sean Chappin, M.D., Beth Israel Medical Center |
| ClinicalTrials.gov Identifier: | NCT00668265 History of Changes |
| Other Study ID Numbers: | IRB # (112-07), IRUSQUET0443 |
| Study First Received: | April 28, 2008 |
| Last Updated: | March 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Generalized Anxiety Disorder Opiate Dependence Methadone-Maintenance Drug Addiction Treatment |
|
Anxiety Disorders Opioid-Related Disorders Mental Disorders Substance-Related Disorders Quetiapine Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |