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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000788

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis HIV Infections	Drug: Methadone hydrochloride Drug: Fluconazole	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

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

Actual Study Completion Date :

Jun 1, 1994

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.