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NCT01549652 · ClinicalTrials.gov registry record · NA
5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence
A NA study of Opioid Withdrawal and Physical Dependence, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 133
- Enrollment target
- 1
- Study location
NCT01549652: Completed NA study of Opioid Withdrawal and Physical Dependence, sponsored by Stanford University.
NCT01549652 is a NA study of Opioid Withdrawal and Physical Dependence that has completed, run by Stanford University. The registered enrollment target is 133 participants, above the 110-participant average among 9 other Opioid Withdrawal trials with a reported enrollment target (21% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01549652, a NA study of Opioid Withdrawal and Physical Dependence, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 133 participants
- Enrollment target
- 1
- Study location
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. 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.
Primary Outcome
Originally developed by Handelsman, the Objective Opioid Withdrawal Scale (OOWS) score is a well-characterized measure of opioid withdrawal in humans, calculated as the sum of a 13-item physician assessment documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. The minimum score of 0 means the patient is not showing any signs of opioid withdrawal. The maximum score of 13 signifies all signs of opioid withdrawal to the la
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ondansetron
- DRUG Morphine
- DRUG Naloxone 0.4 mg/70 kg
- DRUG Naloxone 0.8 mg/70 kg
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2011-04 |
| Est. Completion | 2016-10 |
| Phase | NA |
What the finished NCT01549652 record still lists
NCT01549652 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, above the 110-participant average among 9 other Opioid Withdrawal trials with a reported enrollment target (21% higher).
The record links to 2 conditions, with Opioid Withdrawal appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01549652 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01549652 about?
NCT01549652 is a clinical study titled "5HT3 Antagonists to Treat Opioid Withdrawal and to Prevent the Progression of Physical Dependence". 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...
What is the current status of trial NCT01549652?
This trial is currently completed. It is a NA study. The enrollment target is 133 participants. The study started on 2011-04. Estimated completion is 2016-10.
What conditions does trial NCT01549652 study?
This clinical trial studies the following conditions: Opioid Withdrawal, Physical Dependence.
What interventions are being tested in trial NCT01549652?
The interventions under investigation include: Placebo (DRUG), Ondansetron (DRUG), Morphine (DRUG), Naloxone 0.4 mg/70 kg (DRUG), Naloxone 0.8 mg/70 kg (DRUG).
Who is sponsoring clinical trial NCT01549652?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01549652 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01549652's enrollment target sits among peer trials
133 4th of 9 higher than 6 of 9 other Opioid Withdrawal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Withdrawal 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.
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