Anxiety in Recovering Opiate Dependence
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|ClinicalTrials.gov Identifier: NCT00668265|
Recruitment Status : Terminated (The study was not completed, the funding sponsor lost interest.)
First Posted : April 29, 2008
Results First Posted : February 18, 2013
Last Update Posted : February 18, 2013
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 or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder Comorbid Opiate Dependence in Remission Status Post Methadone-Maintenance Treatment||Drug: Quetiapine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Dosage is 50 - 300 mg, once daily, at bedtime.
Other Name: Seroquel
- Hamilton Anxiety Scale at 16 Weeks [ Time Frame: 16 weeks ]Hamilton anxiety scale -- a well known quantitative measure for assessment of anxiety
- Beck Depression Inventory at 16 Weeks [ Time Frame: 16 weeks ]To compare the effect of Quetiapine vs. placebo on symptoms of negative mood in patients with GAD and comorbid opiate abuse in remission.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|