POWS: Palonosetron/Ondansetron Opioid Withdrawal Study

Substance-Related Disorders Clinical Trial

Official title:

POWS: Palonosetron/Ondansetron Opioid Withdrawal Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661674
• Other study ID #: SU-04152008-1099
• Secondary ID: eprotocol 11004
• Status: Completed
• Phase: N/A
• First received: April 15, 2008
• Last updated: June 5, 2012
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: June 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Description:

We hope to learn if Ondansetron, Palonosetron, and/or combination with hydroxyzine can be used to prevent or attenuate the signs and symptoms of opioid withdrawal. If we find that it can help prevent these symptoms, it may become a new treatment that can aid patients suffering from these symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• healthy men

• ages 18-35

Exclusion Criteria:

• history of substance abuse

• Raynaud's disease or coronary artery disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OOWS score	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.	The OOWS score will be measure 5 times during the study visit, at T=0 minutes, T=10 minutes, T=145 minutes, T=170 minutes, and T=180 minutes.	No
Secondary	SOWS score	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.	The SOWS score will be measure 5 times during the study visit, at T=0 minutes, T=10 minutes, T=145 minutes, T=170 minutes, and T=180 minutes.	No