Trial · NCT01254877
Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons
NCT01254877, Phase 2, Completed, Johns Hopkins University; results first posted 2018-04-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons. Trials, record NCT01254877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01254877
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons
- NCT number
- NCT01254877
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 357 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Alcohol Abuse, Alcohol Dependence
- Interventions
- ondansetron, placebo ondansetron, Ondansetron
- First posted
- 2010-12-07
- Last updated
- 2018-04-17
- Results first posted
- 2018-04-17
- Limitations and caveats
- Drinking data are based on patient self-report.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Alcoholic Containing Drinks Per Drinking Day | 16 weeks | The Time-line Follow-back (TLFB; Sobell, Sobell, Leo \& Cancilla, 1988) is conducted as an interview administered by trained and certified research staff. The interview obtains participant self-reports of daily drinking, including number and type of alcoholic beverages. These data are used to quantify an individual's drinking pattern including the number of drinks per drinking day and drinking frequency. The TLFB was completed biweekly and quantified over the 16-week medication period |
| Primary | Number of Days/Week Abstinent From Alcohol | 16 weeks | The Time-line Follow-back (Sobell, Sobell, Leo \& Cancilla, 1988) is used to obtain this secondary dependent measure. Alcohol use will be assessed biweekly and quantified over the 16-week medication period. Number of days/week abstinent from alcohol is calculated as the number of abstinent days divided by the number of study medication days (adjusted for days in confinement (e.g., hospitalization; jail)) and multiplied by 7. |
| Secondary | Medication Safety | 16 weeks | Medication side-effects and adverse events were measured using the Systematic Assessment for Treatment of Emergent Events (SAFTEE). The SAFTEE contains 25 detailed questions that systematically address 29 body systems. A trained interviewer elicits information about onset, duration, pattern, and judgment of attribution. For the present trial outcome, we report number of events. |
| Secondary | Number of Subjects Who Discontinue Due to Side Effects | 16 weeks | The investigators will count the number of subjects who discontinue medication during the 16-week intervention period due to complaints of side effects. |
| Secondary | Alcohol-related Problems | 16 weeks | Alcohol-related problems were measured using the Short Inventory of Problems - revised (SIP-R), a self-report inventory of adverse consequences associated with alcohol and drug use. The SIP instructs participants to indicate how often each of 15 consequences has occurred during the past three months ("never," "once or a few times," "once or twice a week," "daily or almost daily"; scored 0-3). Item responses are summed to produce a total score and five subscale scores. Total scores range from 0 - 45. |
| Secondary | HIV Medication Adherence | 16 weeks | The investigators will obtain patient self reports of the number of HIV medication doses taken as a function of the total number of doses prescribed. The adherence measure is expressed as the % of prescribed doses. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Alcoholic Containing Drinks Per Drinking Day | 16 weeks | Standard alcohol drinks per drinking day | MEAN | |
| PRIMARY | Number of Days/Week Abstinent From Alcohol | 16 weeks | days/week abstinent from alcohol | MEAN | |
| SECONDARY | Medication Safety | 16 weeks | number of events | MEAN | |
| SECONDARY | Number of Subjects Who Discontinue Due to Side Effects | 16 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Alcohol-related Problems | 16 weeks | units on a scale | MEAN | |
| SECONDARY | HIV Medication Adherence | 16 weeks | percentage of prescribed doses | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Alcoholic Containing Drinks Per Drinking Day | Placebo Ondansetron - Sugar Pill | 5.9 | Standard Deviation 3.8 | Standard alcohol drinks per drinking day | |
| Number of Alcoholic Containing Drinks Per Drinking Day | Low Dose Ondansetron (0.2 mg Bid) | 6.1 | Standard Deviation 4.3 | Standard alcohol drinks per drinking day | |
| Number of Alcoholic Containing Drinks Per Drinking Day | Moderate Dose Ondansetron (0.8 mg Bid) | 5.9 | Standard Deviation 3.9 | Standard alcohol drinks per drinking day | |
| Number of Days/Week Abstinent From Alcohol | Placebo Ondansetron - Sugar Pill | 4.7 | Standard Deviation 2.2 | days/week abstinent from alcohol | |
| Number of Days/Week Abstinent From Alcohol | Low Dose Ondansetron (0.2 mg Bid) | 4.9 | Standard Deviation 2.0 | days/week abstinent from alcohol | |
| Number of Days/Week Abstinent From Alcohol | Moderate Dose Ondansetron (0.8 mg Bid) | 4.8 | Standard Deviation 2.2 | days/week abstinent from alcohol | |
| Medication Safety | Placebo Ondansetron - Sugar Pill | 11.4 | Standard Deviation 11.1 | number of events | |
| Medication Safety | Low Dose Ondansetron (0.2 mg Bid) | 12.4 | Standard Deviation 13.4 | number of events | |
| Medication Safety | Moderate Dose Ondansetron (0.8 mg Bid) | 11.0 | Standard Deviation 12.3 | number of events | |
| Number of Subjects Who Discontinue Due to Side Effects | Placebo Ondansetron - Sugar Pill | 0 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Ondansetron - Sugar Pill | 67 | |
| Overall Study | STARTED | Low Dose Ondansetron (0.2 mg Bid) | 69 | |
| Overall Study | STARTED | Moderate Dose Ondansetron (0.8 mg Bid) | 69 | |
| Overall Study | COMPLETED | Placebo Ondansetron - Sugar Pill | 57 | |
| Overall Study | COMPLETED | Low Dose Ondansetron (0.2 mg Bid) | 58 | |
| Overall Study | COMPLETED | Moderate Dose Ondansetron (0.8 mg Bid) | 64 | |
| Overall Study | NOT COMPLETED | Placebo Ondansetron - Sugar Pill | 10 | |
| Overall Study | NOT COMPLETED | Low Dose Ondansetron (0.2 mg Bid) | 11 | |
| Overall Study | NOT COMPLETED | Moderate Dose Ondansetron (0.8 mg Bid) | 5 |
Source ClinicalTrials.gov
Adverse events30
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 | Events |
|---|---|---|---|---|---|---|
| other | Cough/cold symptoms | Respiratory, thoracic and mediastinal disorders | Placebo Ondansetron - Sugar Pill | 3 | 67 | 3 |
| other | Cough/cold symptoms | Respiratory, thoracic and mediastinal disorders | Low Dose Ondansetron (0.2 mg Bid) | 2 | 69 | 2 |
| other | Cough/cold symptoms | Respiratory, thoracic and mediastinal disorders | Moderate Dose Ondansetron (0.8 mg Bid) | 4 | 69 | 4 |
| other | Alcohol intoxication/withdrawal | Psychiatric disorders | Placebo Ondansetron - Sugar Pill | 2 | 67 | 2 |
| other | Alcohol intoxication/withdrawal | Psychiatric disorders | Low Dose Ondansetron (0.2 mg Bid) | 1 | 69 | 1 |
| other | Alcohol intoxication/withdrawal | Psychiatric disorders | Moderate Dose Ondansetron (0.8 mg Bid) | 1 | 69 | 1 |
| other | Rash/wound infection | Skin and subcutaneous tissue disorders | Placebo Ondansetron - Sugar Pill | 1 | 67 | 1 |
| other | Rash/wound infection | Skin and subcutaneous tissue disorders | Low Dose Ondansetron (0.2 mg Bid) | 0 | 69 | 0 |
| other | Rash/wound infection | Skin and subcutaneous tissue disorders | Moderate Dose Ondansetron (0.8 mg Bid) | 2 | 69 | 2 |
| other | Other | General disorders | Placebo Ondansetron - Sugar Pill | 1 | 67 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Ondansetron - Sugar Pill | 1 | 67 |
| Total, all-cause mortality | Low Dose Ondansetron (0.2 mg Bid) | 0 | 67 |
| Total, all-cause mortality | Moderate Dose Ondansetron (0.8 mg Bid) | 1 | 69 |
| Total, other adverse events | Placebo Ondansetron - Sugar Pill | 7 | 67 |
| Total, other adverse events | Low Dose Ondansetron (0.2 mg Bid) | 5 | 69 |
| Total, other adverse events | Moderate Dose Ondansetron (0.8 mg Bid) | 8 | 69 |
| Total, serious adverse events | Placebo Ondansetron - Sugar Pill | 16 | 67 |
| Total, serious adverse events | Low Dose Ondansetron (0.2 mg Bid) | 20 | 69 |
| Total, serious adverse events | Moderate Dose Ondansetron (0.8 mg Bid) | 5 | 69 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 10944641 | BACKGROUND |
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 |
|---|---|---|---|---|---|
| R01AA018896 | Ondansetron Pharmacotherapy for Hazardous Drinking, HIV+, African-American Women | MCCAUL, MARY E | JOHNS HOPKINS UNIVERSITY | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2009 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT01254877
GET https://conductscience.org/api/trials/v1/NCT01254877/events?page=2