Pharmacotherapy for HIV+ Stimulant Dependent Individuals

NCT00599573 | Unknown DMC

• 1 other identifier: 13295
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The hypotheses of this study are:

1. 1.Ondansetron will show a decrease in cocaine use from baseline in individuals with HIV who are cocaine using.
2. 2.Ondansetron will show a decrease in cravings from baseline in individuals with HIV who are cocaine using.

Conditions

HIV Infections; Cocaine Dependence

Keywords

HIV; cocaine dependence; cocaine abuse; cocaine addiction; cocaine users; cocaine-related disorders; HIV Infection

Outcome Measures

Primary Outcomes (1)

• adverse events associated with the use of ondansetron

  6 weeks

Secondary Outcomes (2)

• cocaine use

  6 weeks

• cocaine cravings

  6 weeks

Study Arms (1)

1

EXPERIMENTAL

Ondansetron

Drug: ondansetron

Interventions

ondansetron DRUG

Ondansetron 4mg BID for six weeks

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infected individuals who are cocaine dependent based on the Diagnostic and Statistical Manual IV-R
• years of age
• Ability to read and write in English
• Seeking treatment for cocaine dependence
• Drug of dependence screen or benzoylecgonine urine specimen (metabolite of cocaine) positive within the 2 weeks prior to study medication administration
• If female, non-pregnant or breast feeding and willing to use acceptable form of contraception including oral contraceptives, hormonal (levonorgestrel) or surgical implants or barrier plus spermicide
• Liver function tests and Chemistries from CARECAST or by blood draw within the last 3 months that must show no disease of the kidney or liver that could result in altered metabolism or excretion of the study agent. AST and ALT can be no greater than twice the upper limit of normal
• An EKG that shows no clinically significant abnormalities including but not limited to bundle branch blocks, bradycardia with heart rate less than 50, tachycardia with heart rate greater than 105

You may not qualify if:

• Inability to process and sign informed consent
• Pregnant or nursing or unwilling to use contraception if female
• Restrictions on use of other drugs or treatments: The following medications which are established or theoretically have a drug-drug interaction include: Apomorphine (established),Mesoridazine (theoretical), Pimozide (theoretical), Thioridazine (theoretical), Acecainide (theoretical), Amiodarone (theoretical), Arsenic Trioxide (theoretical), Azimilide (theoretical), Bretylium (theoretical), Dofetilide (theoretical), Droperidol (theoretical), Enflurane (theoretical), Halothane (theoretical), Ibutilide (theoretical), Isoflurane (theoretical), Isradipine (theoretical), Sematilide (theoretical), Sotalol (theoretical)
• History of neuroleptic malignant syndrome
• Allergy to ondansetron
• Clinically significant cardiovascular abnormality (EKG) or history of arrhythmias

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections; Cocaine-Related Disorders

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Gabrielle Marzani-Nissen, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabrielle Marzani-Nissen, MD

CONTACT

434-924-2241; grm2a@virginia.edu

Jennifer Crosby

CONTACT

434-243-0545; jac8tr@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 24, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 14, 2010

Record last verified: 2010-04

Locations

US (1)