A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis; HIV Infections
Intervention: Methadone hydrochloride (Drug); Fluconazole (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Cobb M, Study Chair
Letts A, Study Chair
Summary
To evaluate the pharmacokinetics and safety of concomitant administration of methadone and
fluconazole.
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.
Clinical Details
Official title: A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
Study design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Detailed description:
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 administered as close to 8 AM as possible. Patients must
visit the Fort Greene clinic on study days 1, 2, 15, and 16; they may receive treatment at
their home clinics on days 3 through 14.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Addiction Research and Treatment Corp, Brooklyn, New York 11201, United States
Additional Information
Click here for more information about Fluconazole
Related publications: Cobb M, Desai J, Brown LS, Zannikos P, Trapnell C, Rainey P. The effect of fluconazole on the clinical pharmacokinetics of methadone. Int Conf AIDS. 1996 Jul 7-12;11(1):88 (abstract no MoB1196) Cobb MN, Desai J, Brown LS Jr, Zannikos PN, Rainey PM. The effect of fluconazole on the clinical pharmacokinetics of methadone. Clin Pharmacol Ther. 1998 Jun;63(6):655-62.
Last updated: September 28, 2013
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