Anxiety in Recovering Opiate Dependence

This study has been terminated.
(The study was not completed, the funding sponsor lost interest.)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Beth Israel Medical Center
ClinicalTrials.gov Identifier:
NCT00668265
First received: April 28, 2008
Last updated: February 15, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Generalized Anxiety Disorder
Comorbid Opiate Dependence in Remission
Status Post Methadone-Maintenance Treatment
Drug: Quetiapine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Beth Israel Medical Center:

Primary Outcome Measures:
  • Hamilton Anxiety Scale at 16 Weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Hamilton anxiety scale -- a well known quantitative measure for assessment of anxiety


Secondary Outcome Measures:
  • Beck Depression Inventory at 16 Weeks [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    To compare the effect of Quetiapine vs. placebo on symptoms of negative mood in patients with GAD and comorbid opiate abuse in remission.


Enrollment: 14
Study Start Date: January 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Seroquel Drug: Quetiapine
Dosage is 50 - 300 mg, once daily, at bedtime.
Other Name: Seroquel

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668265

Locations
United States, New York
Su Casa Methadone-to-Abstinence Rehabilitation
New York, New York, United States, 10002
Sponsors and Collaborators
Beth Israel Medical Center
AstraZeneca
Investigators
Principal Investigator: Sean Chappin, M.D. Beth Israel Medical Center
  More Information

No publications provided

Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00668265     History of Changes
Other Study ID Numbers: IRB # (112-07), IRUSQUET0443
Study First Received: April 28, 2008
Results First Received: October 19, 2012
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Medical Center:
Generalized Anxiety Disorder
Opiate Dependence
Methadone-Maintenance
Drug Addiction Treatment

Additional relevant MeSH terms:
Anxiety Disorders
Opioid-Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on October 19, 2014