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.
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.
United States1 site, 1 recruiting
- 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
About this study
The hypotheses of this study are:
- Ondansetron will show a decrease in cocaine use from baseline in individuals with HIV who are cocaine using.
- 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.
- Conditions
- HIV Infections, Cocaine Dependence
- 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.
ondansetronDrug
Ondansetron 4mg BID for six weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ondansetron Receives: Drug: ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events associated with the use of ondansetron
Measured: 6 weeks
Secondary outcomes (2)
cocaine use
Measured: 6 weeks
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.
- First posted24 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Gabrielle Marzani-Nissen, MD, Principal investigator, University of Virginia
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacotherapy for HIV+ Stimulant Dependent Individuals
- ClinicalTrials.gov ID
- NCT00599573
- Acronym / sponsor ID
- 13295
- Conditions
- HIV Infections, Cocaine Dependence
- Keywords
- HIV, cocaine dependence, cocaine abuse, cocaine addiction, cocaine users, cocaine-related disorders, HIV Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypotheses of this study are:
- Ondansetron will show a decrease in cocaine use from baseline in individuals with HIV who are cocaine using.
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ondansetronOndansetron |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ondansetronOndansetron 4mg BID for six weeks | Drug | 1 |
Primary outcome
adverse events associated with the use of ondansetron
Time frame: 6 weeks
2 secondary outcomes
cocaine use
Time frame: 6 weeks
cocaine cravings
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabrielle Marzani-Nissen, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
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.