Trial · NCT00689572

New Medication Treatment for Stimulant Dependence

NCT00689572, Phase 2, Completed, University of Virginia; results first posted 2021-11-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. New Medication Treatment for Stimulant Dependence. Trials, record NCT00689572. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00689572

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: New Medication Treatment for Stimulant Dependence
NCT number: NCT00689572
Status: Completed
Phases: Phase 2
Enrollment: 108 participants, actual
Lead sponsor: University of Virginia
Conditions: Cocaine Dependence
Interventions: Ondansetron, Placebo
First posted: 2008-06-03
Last updated: 2021-11-11
Results first posted: 2021-11-11

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cocaine Use by Self-report	up to 9 weeks	Participants were assessed up to three times weekly for up to 9 weeks to evaluate cocaine use by self-report
Primary	Cocaine Use by Urine Benzoylecgonine	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

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Cocaine Use by Self-report	up to 9 weeks	All participants who completed at least one randomly allocated treatment visit were included in the intent-to-treat population.	Percent of cocaine-free (abstinent)days	MEAN
PRIMARY	Cocaine Use by Urine Benzoylecgonine	up to 9 weeks	All participants who completed at least one randomly allocated treatment visit were included in the intent-to-treat population.	Percent of cocaine-free urines	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Cocaine Use by Self-report	Ondansetron	67	Standard Deviation 0.25	Percent of cocaine-free (abstinent)days
Cocaine Use by Self-report	Placebo	67	Standard Deviation 0.22	Percent of cocaine-free (abstinent)days
Cocaine Use by Urine Benzoylecgonine	Ondansetron	16	Standard Deviation 0.32	Percent of cocaine-free urines
Cocaine Use by Urine Benzoylecgonine	Placebo	26	Standard Deviation 0.33	Percent of cocaine-free urines

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ondansetron	53
Overall Study	STARTED	Placebo	55
Overall Study	COMPLETED	Ondansetron	39
Overall Study	COMPLETED	Placebo	34
Overall Study	NOT COMPLETED	Ondansetron	14
Overall Study	NOT COMPLETED	Placebo	21

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal Pain	Gastrointestinal disorders	Ondansetron	19	53
other	Abdominal Pain	Gastrointestinal disorders	Placebo	14	55
other	Anxiety	Psychiatric disorders	Ondansetron	7	53
other	Anxiety	Psychiatric disorders	Placebo	11	55
other	Appetite Increase	Gastrointestinal disorders	Ondansetron	18	53
other	Appetite Increase	Gastrointestinal disorders	Placebo	12	55
other	Appetite Decrease	Gastrointestinal disorders	Ondansetron	18	53
other	Appetite Decrease	Gastrointestinal disorders	Placebo	17	55
other	Constipation	Gastrointestinal disorders	Ondansetron	34	53
other	Constipation	Gastrointestinal disorders	Placebo	16	55

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ondansetron	0	53
Total, all-cause mortality	Placebo	0	55
Total, other adverse events	Ondansetron	44	53
Total, other adverse events	Placebo	47	55
Total, serious adverse events	Ondansetron	1	53
Total, serious adverse events	Placebo	1	55

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34600264	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DA021776	New Medication Treatments for Stimulant Dependence	AIT-DAOUD, NASSIMA	UNIVERSITY OF VIRGINIA	NATIONAL INSTITUTE ON DRUG ABUSE	2007 to 2012

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ondansetron vs Placebo: deaths from any cause	Trial comparisons
Ondansetron vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00689572

GET https://conductscience.org/api/trials/v1/NCT00689572/events?page=2

API reference For AI assistants