CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 133 enrolled
Drug / intervention
Ondansetron +4 moredrug
Likely dose
Naloxone 0.4 mg/70 kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01549652
NCT01549652N/ACompleted
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5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence

Stanford University·interventional·Posted Mar 9, 2012·Updated Jan 7, 2019

In Brief

A clinical study evaluating Ondansetron, Placebo, and 3 other interventions for Opioid Withdrawal and Physical Dependence. Completed, enrolled 133 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Withdrawal, Physical Dependence
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2012
Enrollment StartApr 1, 2011
Primary CompletionApr 1, 2015
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 14.3 years ago

Interventions

Ondansetrondrug

Ondansetron 8 mg oral tablet

Placebodrug

Placebo to Match Ondansetron

Morphinedrug

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

Naloxone 0.4 mg/70 kgdrug

Naloxone 0.4 mg/70 kg intravenous

Naloxone 0.8 mg/70 kgdrug

Naloxone 0.8 mg/70 kg intravenous