NCT00668265

Anxiety in Recovering Opiate Dependence

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Beth Israel Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Generalized Anxiety Disorder
• Comorbid Opiate Dependence in Remission
• Status Post Methadone-Maintenance Treatment

Interventions

Type	Name	Description
DRUG	Quetiapine	Dosage is 50 - 300 mg, once daily, at bedtime.

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2008-04-29
• Last updated: 2013-02-18
• Results posted: 2013-02-18

Locations

1 site across 1 country: United States