Search / Trial NCT00000788

A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 08, 2024

Completed

Keywords

Methadone Drug Interactions Drug Therapy, Combination Fluconazole Antifungal Agents Acquired Immunodeficiency Syndrome Aids Related Complex

ClinConnect Summary

Injection drug users constitute the second largest subset of the U.S. population at risk for HIV infection and AIDS-associated mortality. Narcotic addiction is often treated by use of methadone. Fluconazole has been shown to be highly effective in treating symptomatic mucosal candidiasis, but it is unknown whether fluconazole affects methadone metabolism, which could result in symptoms of methadone withdrawal or overdose in patients taking the drugs in combination.

Patients are randomized to receive methadone plus either fluconazole or placebo in clinic daily for 16 days. Study drugs are a...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Antiretroviral therapy.
  • Intermittent acetaminophen, aspirin, and ibuprofen.
  • Patients must have:
  • CD4 count \>= 250 cells/mm3 within 3 months prior to study entry.
  • Received a stable dose of methadone for a minimum of 30 days prior to study entry.
  • Negative urine toxicology screen (except for methadone or methadone metabolites) within 14 days prior to study entry.
  • Reasonably good health.
  • Life expectancy of at least 6 months.
  • Ability and willingness to comply with protocol requirements.
  • NOTE:
  • Patients will be recruited from the methadone maintenance treatment program currently administered by Addiction Research and Treatment Corporation. Enrollment of women is encouraged.
  • NOTE:
  • Patients who are currently enrolled in CPCRA treatment and prophylaxis trials are eligible for this study provided they have been permanently removed from study drug on the other protocol.
  • Prior Medication:
  • Required:
  • Stable dose of methadone for a minimum of 30 days prior to study entry.
  • Allowed:
  • Prior antiretroviral therapy (dose should be stable for 14 days prior to study entry).
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Known sensitivity to azoles, methadone, and other opiate narcotics.
  • Concurrent Medication:
  • Excluded:
  • Amiodarone.
  • Anesthetics, general.
  • Barbiturates.
  • Carbamazepine.
  • Cimetidine.
  • Ciprofloxacin.
  • Dexamethasone.
  • Disulfiram.
  • Erythromycin.
  • Fluoroquinolones.
  • Fluoxetine.
  • Gestodene.
  • Hydrochlorothiazide.
  • Hypoglycemics, oral.
  • Isoniazid.
  • Itraconazole.
  • Ketoconazole.
  • Levomepromazine.
  • MAO inhibitors.
  • Methoxsalen.
  • Nafcillin.
  • Narcotic analgesics.
  • Naringenin.
  • Norethindrone.
  • Omeprazole.
  • Pentazocine.
  • Phenothiazines.
  • Phenytoin.
  • Quinidine.
  • Ranitidine.
  • Rifabutin.
  • Rifampin.
  • Sedative hypnotics.
  • Sulfaphenazole.
  • Tranquilizers.
  • Tricyclic antidepressants.
  • Troleandomycin.
  • Warfarin.
  • Prior Medication:
  • Excluded within 30 days prior to study entry:
  • Ketoconazole, fluconazole, or itraconazole.
  • Experimental drugs.
  • Alcohol or illicit drug abuse.

Trial Officials

Cobb M

Study Chair

Letts A

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Brooklyn, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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