Anxiety in Recovering Opiate Dependence

NCT00668265 | Terminated Phase 4 Results

• 2 other identifiers: IRB # (112-07)IRUSQUET0443
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Generalized Anxiety Disorder; Opiate Dependence; Methadone-Maintenance; Drug Addiction Treatment

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Scale at 16 Weeks

  Hamilton anxiety scale -- a well known quantitative measure for assessment of anxiety

  16 weeks

Secondary Outcomes (1)

• Beck Depression Inventory at 16 Weeks

  16 weeks

Study Arms (1)

Seroquel

EXPERIMENTAL

Drug: Quetiapine

Interventions

Quetiapine DRUG

Dosage is 50 - 300 mg, once daily, at bedtime.

Also known as: Seroquel

Seroquel

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Su Casa Methadone-to-Abstinence Rehabilitation

New York, New York, 10002, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Opioid-Related Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Igor Galynker, MD
• Organization: Beth Israel Medical Center

igalynke@chpnet.org

212 420 4535

Study Officials

• Sean Chappin, M.D.

  Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 29, 2008
• Study Start: January 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 18, 2013
• Results First Posted: February 18, 2013

Record last verified: 2013-02

Locations

US (1)