Anxiety in Recovering Opiate Dependence
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.
Generalized Anxiety Disorder
Comorbid Opiate Dependence in Remission
Status Post Methadone-Maintenance Treatment
|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|
- Hamilton Anxiety Scale at 16 Weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Hamilton anxiety scale -- a well known quantitative measure for assessment of anxiety
- Beck Depression Inventory at 16 Weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]To compare the effect of Quetiapine vs. placebo on symptoms of negative mood in patients with GAD and comorbid opiate abuse in remission.
|Study Start Date:||January 2008|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Dosage is 50 - 300 mg, once daily, at bedtime.
Other Name: Seroquel
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668265
|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|