MedTrace Logo

Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal

NCT00661674 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-06-05

Study results available
· View outcomes & findings →

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).

Conditions

  • Substance-Related Disorders

Interventions

DRUG

Palonosetron

Over 3 study visits, patients will receive one of the following treatment regimens: * Placebo saline IV and sugar pill * 0.75 mg Palonosetron IV and sugar pill * 0.75 mg Palonosetron IV and 100 mg hydroxyzine PO

DRUG

Hydroxyzine

Over 3 study visits, patients will receive one of the following treatment regimens: * Placebo saline IV and sugar pill * 0.75 mg Palonosetron IV and sugar pill * 0.75 mg Palonosetron IV and 100 mg hydroxyzine PO

OTHER

Placebo

Over 3 study visits, patients will receive one of the following treatment regimens: * Placebo saline IV and sugar pill * 0.75 mg Palonosetron IV and sugar pill * 0.75 mg Palonosetron IV and 100 mg hydroxyzine PO

Sponsors & Collaborators

Principal Investigators

  • Dr Larry Fu-nien Chu · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00661674 on ClinicalTrials.gov