Recruiting

HIV Pharmacotherapy

Sponsor:

University of Virginia

Code:

NCT00599573

Conditions

HIV Infections

Cocaine Dependence

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ondansetron

Study Details

Brief summary:

The hypotheses of this study are:

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

After informed consent and screening, HIV infected individuals who are cocaine dependent and qualify for the study will be offered ondansetron 4mg BID for six weeks in an open label format 4mg BID has been found to have efficacy compared to placebo. At screening and then at each visit, they will be asked to provide urine and a drug of abuse screen will be conducted to assess for cocaine. They will be asked to detail their recent cocaine use in the last month and then will be given a visual analog scale to assess their craving for cocaine. They will be asked to return weekly for 6 weeks to receive a week's supply of ondansetron and to give a urine sample that will test for cocaine. They will fill out a time line follow back for the past week and asked to assess their craving for cocaine on a visual analog scale.

Conditions

HIV Infections

Cocaine Dependence

Study ID

NCT00599573

Start date

Oct, 2007

Status verified date

Apr, 2010

Completion date

Dec, 2010

Anticipated

Primary completion date

Jul, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • HIV infected individuals who are cocaine dependent based on the Diagnostic and Statistical Manual IV-R
  • 18-64 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

Exclusion Criteria:

  • Non-English speaking (As these individuals are filling out rating forms, the criteria for exclusion is directly related to ability to read and process information in English.)
  • 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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Ondansetron

Interventions

ondansetron

Ondansetron 4mg BID for six weeks

Primary outcome measure

  • adverse events associated with the use of ondansetron [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Gabrielle Marzani-Nissen, MD

434-924-2241grm2a@virginia.edu

Jennifer Crosby

434-243-0545jac8tr@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Gabrielle Marzani-Nissen, MD

434-924-2241grm2a@virginia.edu

Jennifer Crosby

434-243-0545jac8tr@virginia.edu

Principal Investigator:

Gabreille Marzani-Nissen, MD

More Information

Sponsor

University of Virginia

Last update posted

Apr 14, 2010

Last verified

Apr, 2010

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2010-04-14.