A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
2 other identifiers
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for phase_1
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
June 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 3, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +5 more criteria
You may not qualify if:
- 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.
- +33 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Addiction Research and Treatment Corp
Brooklyn, New York, 11201, United States
Related Publications (1)
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. doi: 10.1016/S0009-9236(98)90089-3.
PMID: 9663180BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cobb M
- STUDY CHAIR
Letts A
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
June 1, 1994
Last Updated
November 3, 2021
Record last verified: 2021-10