Anxiety in Recovering Opiate Dependence
Condition: Generalized Anxiety Disorder; Comorbid Opiate Dependence in Remission; Status Post Methadone-Maintenance Treatment
MeSH terms: Opioid-Related Disorders; Anxiety Disorders
Intervention: Quetiapine
Intervention description: Dosage is 50 - 300 mg, once daily, at bedtime.
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder; Opiate Dependence; Methadone-Maintenance; Drug Addiction Treatment

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent

          -  A diagnosis of opiate dependence as defined by Diagnostic and Statistical Manual of
             Mental Disorders- Fourth Edition (DSM-IV) during the past two years.

          -  A diagnosis of generalized anxiety disorder as defined by Diagnostic and Statistical
             Manual of Mental Disorders- Fourth Edition (DSM-IV) within the past 6 months.

          -  Males and females aged 21-55 years

          -  Female patients of childbearing potential must be using a reliable method of
             contraception and have a negative urine human chorionic gonadotropin (HCG) test at
             enrollment

          -  Able to understand and comply with the requirements of the study

          -  Subjects must be free of illicit drug use for the past 3 months

          -  Subjects must have received methadone maintenance therapy for at least 3 months, and
             have been at least 2 weeks methadone-free

          -  Good health, as assessed by medical history, physical examination and laboratory tests

        Exclusion Criteria:

          -  Pregnancy or lactation

          -  Current diagnosis of any Axis I disorder other than GAD, substance dependence in
             remission, or nicotine dependence

          -  Patients who, in the opinion of the investigator, pose an imminent risk of suicide or
             a danger to self or others

          -  Known intolerance or lack of response to quetiapine fumarate, as judged by the
             investigator

          -  Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding
             enrolment including but not limited to: ketoconazole, itraconazole, fluconazole,
             erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir,
             fluvoxamine and saquinavir

          -  Use of any of the following cytochrome P450 inducers in the 14 days preceding
             enrollment including but not limited to: phenytoin, carbamazepine, barbiturates,
             rifampin, St. John's Wort, and glucocorticoids

          -  Administration of a depot antipsychotic injection within one dosing interval (for the
             depot) before randomisation

          -  Medical conditions that would affect absorption, distribution, metabolism, or
             excretion of study treatment

          -  Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris,
             hypertension) as judged by the investigator

          -  Involvement in the planning and conduct of the study

          -  Previous enrollment or randomisation of treatment in the present study.

          -  Participation in another drug trial within 4 weeks prior enrollment into this study or
             longer in accordance with local requirements

          -  A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:

          -  Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) >8.5%.

          -  Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.

          -  Not under physician care for DM

          -  Physician responsible for patient's DM care has not indicated that patient's DM is
             controlled.

          -  Physician responsible for patient's DM care has not approved patient's participation
             in the study

          -  Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4
             weeks prior to randomization. For thiazolidinediones (glitazones) this period should
             not be less than 8 weeks.

          -  Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than
             10% above or below their mean dose in the preceding 4 weeks Note: If a diabetic
             patient meets one of these criteria, the patient is to be excluded even if the
             treating physician believes that the patient is stable and can participate in the
             study.

          -  An absolute neutrophil count (ANC) of 1.5 x 109 per liter

          -  Positive urine drug screening test for drugs of abuse