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HIV InfectionsNCT00599573

Pharmacotherapy for HIV+ Stimulant Dependent Individuals

A study testing ondansetron in people with HIV Infections and Cocaine Dependence, run by University of Virginia at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV Infections, Cocaine Dependence
What is being tested?
ondansetron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Oct 2007to Dec 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Gabrielle Marzani-Nissen, MD contact

434-924-2241

grm2a@virginia.edu

Jennifer Crosby contact

434-243-0545

jac8tr@virginia.edu

United States1 site, 1 recruiting
  • University of Virginia

    Charlottesville, Virginia, 22908

    Gabrielle Marzani-Nissen, MD, 434-924-2241, grm2a@virginia.edu

    Jennifer Crosby, 434-243-0545, jac8tr@virginia.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

In 1996, the use of protease inhibitors and triple therapy known as HAART (highly active antiretroviral therapies) became widespread in the United States for the treatment of HIV. This changed the disease process from a relentless and progressive one to a chronic one, with the resulting need to focus on issues related to adherence. Because of unique aspects of viral resistance with HIV, an adherence rate of 95% or higher is required to minimize or halt the progression of the disease (DeMasi et al., 2001; Gross, Bilker, Friedman, \& Strom, 2001). Cocaine use and dependence has been found to have deleterious effects on HIV infected individuals (Fiala et al., 2005) Cocaine use hastens disease progression, increases viral loads and decreases CD4 counts(Arnsten et al., 2002; Baldwin, Roth, \& Tashkin, 1998; Hurwitz, ; Kapadia, Vlahov, Donahoe, \& Friedland, 2005; Lucas et al., 2006; Roth et al., 2002; Roth, Whittaker, Choi, Tashkin, \& Baldwin, 2005) Cocaine use correlates with increased "no show" clinic visits and decreased or no-adherence to HIV medications. (Hinkin et al., 2007; Ingersoll, 2004; Palepu, Horton, Tibbetts, Meli, \& Samet, 2004; Sharpe, Lee, Nakashima, Elam-Evans, \& Fleming, 2004) There appear to be multiple reasons for non-adherence in this substance abusing population. Factors such as forgetting and running out of medications have been implicated with substances such as crack cocaine and heroin. (Ingersoll, 2004; Kerr et al., 2004)

A medication that decreases or ceases cocaine use potentially improves adherence at clinic appointments as well as adherence to medication. In addition, it might indirectly decrease the progression of the disease. Ondansetron, a serotonin type 3 receptor antagonist (5HT3), at 4mg twice a day has been shown to have a greater rate of improvement in percentage of participants with a cocaine-free week compared to placebo in cocaine dependent non HIV infected treatment seeking individuals. (Johnson, B.A. 2006)

Ondansetron is FDA approved for chemotherapy induced nausea and vomiting, postoperative nausea and vomiting and radiation induced nausea and vomiting. Ondansetron has shown efficacy for nausea and vomiting in HIV infected individuals for palliation, as well as for diarrhea due to cryptosporidium infection.(Currow, Coughlan, Fardell, \& Cooney, 1997; Gompels et al., 1993; Schworer, Hartmann, \& Ramadori, 1994) Until recently, ondansetron's cost was prohibitive. However, as a generic drug it has become more affordable. Among the benefits of this drug is the qualitative benefits for HIV infected individuals with nausea and diarrhea as well as cocaine dependence. HIV medications can cause nausea (M. O. Johnson, Stallworth, \& Neilands, 2003; M. O. Johnson et al., 2005; O'Brien, Clark, Besch, Myers, \& Kissinger, 2003; Reynolds \& Neidig, 2002) and thus adherence might be improved with this medication in cocaine using individuals. Ondansetron is well tolerated in HIV infected individuals, and according to micromedex there are no known drug interactions with HIV medications (Gompels et al., 1993)

Ondansetron has a mild adverse events profile. In studies with cocaine dependent individuals who were not HIV infected, our group found that Ondansetron had fewer side effects than placebo (B. A. Johnson et al., 2006). Also, in that same study, Ondansetron recipients attended more sessions than those of placebo. Both of these factors make this drug an appealing option for cocaine dependent HIV infected individuals.

Being tested
ondansetron
Keywords
HIV, cocaine dependence, cocaine abuse, cocaine addiction, cocaine users, cocaine-related disorders, HIV Infection
Medical subject headings
HIV Infections, Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00599573
Study groupRoleWhat they receive
1ExperimentalOndansetron
Receives: Drug: ondansetron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. adverse events associated with the use of ondansetron

    Measured: 6 weeks

Secondary outcomes (2)
  1. cocaine use

    Measured: 6 weeks

  2. cocaine cravings

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionJul 2010 (estimated)
  4. Study completionDec 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00599573
Sponsor's protocol ID
13295
Status last verified
Apr 2010
First submitted
10 Jan 2008
Last updated
14 Apr 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing ondansetron in people with HIV Infections and Cocaine Dependence, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gabrielle Marzani-Nissen, MD (434-924-2241, grm2a@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

adverse events associated with the use of ondansetron (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2010.

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