drugset / Trial / NCT00668265

Anxiety in Recovering Opiate Dependence

NCT00668265

Phase 4 Terminated 14 enrolled Beth Israel Medical Center AstraZeneca · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2008-01
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Quetiapine Small molecule 50 mg
Subject Quetiapine Small molecule 300 mg