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NCT00661674 · ClinicalTrials.gov registry record · NA

Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal

A NA study, sponsored by Stanford University.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT00661674: Completed NA study, sponsored by Stanford University.

NCT00661674 is a NA study that has completed, run by Stanford University. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00661674, a NA study, has completed, sponsored by Stanford University.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. We are interested in knowing if a medication named Ondansetron can help ease or prevent symptoms associated with opioid withdrawal. We are also interested in knowing if a similar (but more potent FDA-approved drug, palonosetron) can more effectively treat withdrawal symptoms with or without combination with an antihistamine called hydroxyzine (vistaril).

Primary Outcome

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 ti

Interventions

  • OTHER Placebo
  • DRUG Palonosetron
  • DRUG Hydroxyzine

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2008-04
Est. Completion 2008-08
Phase NA
Stanford University

1,744 total trials

What the finished NCT00661674 record still lists

NCT00661674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00661674 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00661674 about?

NCT00661674 is a clinical study titled "Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal". Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. We are interested in knowing if a medication named Ondansetron can help ease o...

What is the current status of trial NCT00661674?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2008-04. Estimated completion is 2008-08.

What interventions are being tested in trial NCT00661674?

The interventions under investigation include: Placebo (OTHER), Palonosetron (DRUG), Hydroxyzine (DRUG).

Who is sponsoring clinical trial NCT00661674?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00661674's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00661674, the US trial registry maintained by the National Library of Medicine. NCT00661674 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.