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5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence

NCT01549652 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2019-01-07

Study results available
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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. This study aims to test the use of the drug ondansetron to reduce the symptoms associated with opioid withdrawal and to prevent the progression of opioid physical dependence, thereby allowing future investigators to better test the role of physical dependence in the development of addiction and also possibly improving acceptance of abstinence-based programs for addiction.

Conditions

  • Opioid Withdrawal
  • Physical Dependence

Interventions

DRUG

Ondansetron

Ondansetron 8 mg oral tablet

DRUG

Placebo

Placebo to Match Ondansetron

DRUG

Morphine

Sustained release oral morphine, beginning at 30 mg/d, titrated up by 15 mg/d every 2 days until adequate analgesia is achieved

DRUG

Naloxone 0.4 mg/70 kg

Naloxone 0.4 mg/70 kg intravenous

DRUG

Naloxone 0.8 mg/70 kg

Naloxone 0.8 mg/70 kg intravenous

Sponsors & Collaborators

Principal Investigators

  • Larry F Chu, MD, MS · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-04-30
Completion
2016-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01549652 on ClinicalTrials.gov