Anxiety in Recovering Opiate Dependence

Generalized Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00668265
• Other study ID #: IRB # (112-07)
• Secondary ID: IRUSQUET0443
• Status: Terminated
• Phase: Phase 4
• First received: April 28, 2008
• Last updated: February 15, 2013
• Start date: January 2008
• Est. completion date: August 2011

Study information

• Verified date: February 2013
• Source: Beth Israel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Quetiapine
Dosage is 50 - 300 mg, once daily, at bedtime.

Locations

Country	Name	City	State
United States	Su Casa Methadone-to-Abstinence Rehabilitation	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Medical Center	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Anxiety Scale at 16 Weeks	Hamilton anxiety scale -- a well known quantitative measure for assessment of anxiety	16 weeks	No
Secondary	Beck Depression Inventory at 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.	16 weeks	No