Cocaine DependencePhase 2NCT00689572
New Medication Treatment for Stimulant Dependence
A Phase 2 study testing Ondansetron in people with Cocaine Dependence, run by University of Virginia at 2 sites in United States.
Trial summary
This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Ondansetron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females who have given written informed consent.
- Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg.
- Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
- Current DSM-IV diagnosis of cocaine dependence.
- At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.
- The pregnancy test for females at intake must be negative.
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- Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
- Answered an advertisement in the newspaper/radio/television, and expressing a wish to stop using cocaine.
- Willing to participate in behavioral treatments for cocaine dependence.
Who cannot join
- Please contact site for additional information
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia Center for Addiction Research and Education
Charlottesville, Virginia, 22911
University of Virginia Center for Addiction Research and Education
Richmond, Virginia, 23294
About this study
This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.
Read the detailed description
We propose to conduct a 9 week randomized, controlled clinical trial to evaluate the efficacy of ondansetron 4 mg twice daily compared with placebo (total N = 100/group × 2 groups = 200 individuals randomized, 400 total subjects will be consented), provided as an adjunct to manual-driven, structured CBT + BBCET in the treatment of cocaine dependence.
- Conditions
- Cocaine Dependence
- Being tested
- Ondansetron, Placebo
- Keywords
- cocaine dependence, cocaine abuse, cocaine, crack
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
PlaceboDrug
Also called Sugar Pill
twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | Ondansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Receives: Drug: Ondansetron |
| Placebo | Placebo comparator | Placebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Use by Self-report
Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report
Measured: up to 9 weeks
Cocaine Use by Urine Benzoylecgonine
Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine
Measured: up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine DependenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Nassima Ait-Daoud Tiouririne, University of Virginia
- Investigators
- Nassima Ait-Daoud Tiouririne, M.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689572
- Sponsor's protocol ID
- 13419
- Other IDs
- 1R01DA021776-01A1
- Status last verified
- Aug 2021
- First submitted
- 29 May 2008
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blevins D, Seneviratne C, Wang XQ, Johnson BA, Ait-Daoud N. A randomized, double-blind, placebo-controlled trial of ondansetron for the treatment of cocaine use disorder with post hoc pharmacogenetic analysis. Drug Alcohol Depend. 2021 Nov 1;228:109074. doi: 10.1016/j.drugalcdep.2021.109074. Epub 2021 Sep 24.
PubMed 34600264
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Medication Treatment for Stimulant Dependence
- ClinicalTrials.gov ID
- NCT00689572
- Acronym / sponsor ID
- 13419
- Conditions
- Cocaine Dependence
- Keywords
- cocaine dependence, cocaine abuse, cocaine, crack
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Jun 2008 (estimated)
- Results
- Posted 11 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.
Detailed description
We propose to conduct a 9 week randomized, controlled clinical trial to evaluate the efficacy of ondansetron 4 mg twice daily compared with placebo (total N = 100/group × 2 groups = 200 individuals randomized, 400 total subjects will be consented), provided as an adjunct to manual-driven, structured CBT + BBCET in the treatment of cocaine dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Experimental | Drug: OndansetronOndansetron + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females who have given written informed consent.
- Ages 18 years and above and, must weigh at least 40 Kg and no more than 140 Kg.
- Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
- Current DSM-IV diagnosis of cocaine dependence.
- At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.
Key exclusion criteria (1 listed)
- Please contact site for additional information
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 |
|---|---|---|
| OndansetronAlso: Zofran4 mg twice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy | Drug | Ondansetron |
| PlaceboAlso: Sugar Pilltwice a day + Cognitive Behavioral Therapy + Brief Behavioral Enhancement Therapy | Drug | Placebo |
Primary outcome
Cocaine Use by Self-report
Time frame: up to 9 weeks
Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report
Cocaine Use by Urine Benzoylecgonine
Time frame: up to 9 weeks
Urine samples were collected up to three times weekly for up to 9 weeks to test for the major cocaine metabolite benzoylecgonine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34600264Blevins D, Seneviratne C, Wang XQ, Johnson BA, Ait-Daoud N. A randomized, double-blind, placebo-controlled trial of ondansetron for the treatment of cocaine use disorder with post hoc pharmacogenetic analysis. Drug Alcohol Depend. 2021 Nov 1;228:109074. doi: 10.1016/j.drugalcdep.2021.109074. Epub 2021 Sep 24.
- (UVA CARE Website)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nassima Ait-Daoud Tiouririne, M.D. principal investigator
University of Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ondansetron in people with Cocaine Dependence, run by University of Virginia at 2 sites 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 9 inclusion and 1 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: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cocaine Use by Self-report (time frame: up to 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00689572, which also lists 1 linked publication.
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 11 Nov 2021.