A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Candidiasis HIV Infections |
Drug: Methadone hydrochloride Drug: Fluconazole |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| Official Title: | A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone |
| Estimated Enrollment: | 24 |
| Study Completion Date: | June 1994 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000788 History of Changes |
| Other Study ID Numbers: | CPCRA 030, 11580 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Methadone Drug Interactions Drug Therapy, Combination Fluconazole |
Antifungal Agents Acquired Immunodeficiency Syndrome AIDS-Related Complex |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Candidiasis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycoses Fluconazole Methadone |
Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Central Nervous System Depressants Antitussive Agents |
ClinicalTrials.gov processed this record on March 10, 2013
