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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000788
First received: November 2, 1999
Last updated: September 28, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 24
Study Completion Date: June 1994
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000788

Locations
United States, New York
Addiction Research and Treatment Corp
Brooklyn, New York, United States, 11201
Sponsors and Collaborators
Investigators
Study Chair: Cobb M
Study Chair: Letts A
  More Information

Additional Information:
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)

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: September 28, 2013
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 July 23, 2014