Trial · NCT00661674
Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal
NCT00661674, Not applicable, Completed, Stanford University; results first posted 2017-06-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal. Trials, record NCT00661674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00661674
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal
- NCT number
- NCT00661674
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 10 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Substance-Related Disorders
- Interventions
- Palonosetron, Hydroxyzine, Placebo
- First posted
- 2008-04-18
- Last updated
- 2017-06-05
- Results first posted
- 2017-06-05
- Limitations and caveats
- Results are not necessarily generalizable to patients with chronic opioid exposure.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | OOWS Score | Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration) | The OOWS is a 13-item instrument documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. Maximum score possible = 13, minimum score possible = 0. T=15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session. OOWS scores at T=180 is the primary outcome measure of the study compared with baseline OOWS scores at T=-30 (30 minutes prior to study medication administration). Reported time frames are in relation to time past since administration of study medications. Mean post-Naloxone OOWS scores (+/- SEM) were determined for pretreatment groups |
| Secondary | SOWS Score | Change from baseline in SOWS score at 180 minutes (15 minutes post naloxone administration) | The SOWS score is composed of 16 subjective symptoms rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. 15 minutes post naloxone administration coordinates with T = 180 (min) for the entire study session. The highest score possible (64) would indicate that the individual was experiencing every symptom of opioid withdrawal to the fullest extent possible while the lowest score (0) would indicate that the individual was not experiencing any symptoms of opioid withdrawal. Mean post-naloxone SOWS scores (+/- SEM) were computed for pretreatment groups: Placebo, palonosetron, and palonosetron with hydroxyzine |
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 | OOWS Score | Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration) | units on a scale (OOWS Scale) | MEAN | |
| SECONDARY | SOWS Score | Change from baseline in SOWS score at 180 minutes (15 minutes post naloxone administration) | units on a scale (SOWS Scale) | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| OOWS Score | Placebo | 3.5 | Standard Error 0.76 | units on a scale (OOWS Scale) | |
| OOWS Score | Palonosetron | 1.0 | Standard Error 0.37 | units on a scale (OOWS Scale) | |
| OOWS Score | Palonosetron + Hydroxyzine | 0 | Standard Error 0.13 | units on a scale (OOWS Scale) | |
| SOWS Score | Placebo | 6.0 | Standard Error 1.86 | units on a scale (SOWS Scale) | |
| SOWS Score | Palonosetron | 4.0 | Standard Error 1.86 | units on a scale (SOWS Scale) | |
| SOWS Score | Palonosetron + Hydroxyzine | 3.5 | Standard Error 1.39 | units on a scale (SOWS Scale) |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence 1: Placebo, Combo, Palonosetron | 2 | |
| Overall Study | STARTED | Sequence 2: Palonosetron, Combo, Placebo | 2 | |
| Overall Study | STARTED | Sequence 3: Combo, Placebo, Palonosetron | 2 | |
| Overall Study | STARTED | Sequence 4: Placebo, Palonosetron, Combo | 1 | |
| Overall Study | STARTED | Sequence 5: Combo, Palonosetron, Placebo | 2 | |
| Overall Study | STARTED | Sequence 6: Palonosetron, Placebo, Combo | 1 | |
| Overall Study | COMPLETED | Sequence 1: Placebo, Combo, Palonosetron | 2 | |
| Overall Study | COMPLETED | Sequence 2: Palonosetron, Combo, Placebo | 2 | |
| Overall Study | COMPLETED | Sequence 3: Combo, Placebo, Palonosetron | 2 | |
| Overall Study | COMPLETED | Sequence 4: Placebo, Palonosetron, Combo | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Palonosetron + Placebo | ||
| Total, all-cause mortality | Palonosetron + Hydroxyzine | ||
| Total, other adverse events | Placebo | 0 | 10 |
| Total, other adverse events | Palonosetron + Placebo | 0 | 10 |
| Total, other adverse events | Palonosetron + Hydroxyzine | 0 | 10 |
| Total, serious adverse events | Placebo | 0 | 10 |
| Total, serious adverse events | Palonosetron + Placebo | 0 | 10 |
| Total, serious adverse events | Palonosetron + Hydroxyzine | 0 | 10 |
Source ClinicalTrials.gov
Papers33
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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/NCT00661674
GET https://conductscience.org/api/trials/v1/NCT00661674/papers?page=2