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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000788
First Posted: August 31, 2001
Last Update Posted: October 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
November 2, 1999
August 31, 2001
October 1, 2013
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Complete list of historical versions of study NCT00000788 on ClinicalTrials.gov Archive Site
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A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone

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.

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.

Interventional
Phase 1
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Candidiasis
  • HIV Infections
  • Drug: Methadone hydrochloride
  • Drug: Fluconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 1994
Not Provided

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00000788
CPCRA 030
11580 ( Registry Identifier: DAIDS ES Registry Number )
Not Provided
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Cobb M
Study Chair: Letts A
National Institute of Allergy and Infectious Diseases (NIAID)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP