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Anxiety in Recovering Opiate Dependence

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

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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
    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 ]
    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


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00668265

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

Responsible Party: Beth Israel Medical Center Identifier: NCT00668265     History of Changes
Other Study ID Numbers: IRB # (112-07)
Study First Received: April 28, 2008
Results First Received: October 19, 2012
Last Updated: February 15, 2013

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

Additional relevant MeSH terms:
Anxiety Disorders
Opioid-Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on April 28, 2017