Anxiety in Recovering Opiate Dependence

Condition(s) targeted: Generalized Anxiety Disorder; Comorbid Opiate Dependence in Remission; Status Post Methadone-Maintenance Treatment

Intervention: Quetiapine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Beth Israel Medical Center

Official(s) and/or principal investigator(s):
James M. Prosser, M.D., Principal Investigator, Affiliation: Beth Israel Medical Center

Overall contact:
James M Prosser, M.D., Phone: 212-844-1422, Email: jprosser@chpnet.org

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.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: To compare the effect of Quetiapine vs. placebo on symptoms of anxiety in patients with GAD and comorbid opiate abuse in remission.

Secondary outcome: To compare the effect of Quetiapine vs. placebo on symptoms of negative mood in patients with GAD and comorbid opiate abuse in remission.

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

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

James M Prosser, M.D., Phone: 212-844-1422, Email: jprosser@chpnet.org

Su Casa Methadone-to-Abstinence Rehabilitation, New York, New York 10002, United States; Recruiting
Kevin Garvey, CASAC, Phone: 212-566-3513, Email: kgarvey@lesc.org

Starting date: January 2008
Ending date: January 2010
Last updated: April 28, 2008