A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
|
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. |
| ClinicalTrials.gov Identifier: NCT00000788 |
|
Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : November 3, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 24 participants |
| 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 : | June 1994 |
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000788
| United States, New York | |
| Addiction Research and Treatment Corp | |
| Brooklyn, New York, United States, 11201 | |
| Study Chair: | Cobb M | ||
| Study Chair: | Letts A |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000788 |
| Other Study ID Numbers: |
CPCRA 030 11580 ( Registry Identifier: DAIDS ES Registry Number ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | November 3, 2021 |
| Last Verified: | October 2021 |
|
Methadone Drug Interactions Drug Therapy, Combination Fluconazole |
Antifungal Agents Acquired Immunodeficiency Syndrome AIDS-Related Complex |
|
Candidiasis Infections Mycoses Bacterial Infections and Mycoses Fluconazole Methadone Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |
Antitussive Agents Respiratory System Agents Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors |