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NCT01006707 · ClinicalTrials.gov registry record · NA
Functional Magnetic Resonance Imaging of Opioid Withdrawal in Healthy Human Volunteers
A NA study of Substance-Related Disorders, sponsored by Stanford University.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01006707: Completed NA study of Substance-Related Disorders, sponsored by Stanford University.
NCT01006707 is a NA study of Substance-Related Disorders that has completed, run by Stanford University. The registered enrollment target is 15 participants, below the 1,521-participant average among 58 other Substance-Related Disorders trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01006707, a NA study of Substance-Related Disorders, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 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. However, we do not know how withdrawal affects the brain. We know that a medication named Ondansetron can help ease or prevent symptoms associated with opioid withdrawal. Through imaging of the brain by fMRI, we hope to see how opioid withdrawal, with and without the administration of ondansetron, affects brain activity.
Primary Outcome
Changes are reporting using Spearman's correlation coefficient, using within-subject factors of time (pre-naloxone, post-naloxone) and pre-treatment (placebo, ondansetron). Changes in Objective Opioid Withdrawal Scale (OOWS) and Subjective Opioid Withdrawal Scale (SOWS) with correlation coefficient \>0.45 are reported. The OOWS consists of 13 observable physical symptoms assessed over a 5-minute observation period and scored as present (score of 1) or absent (score of 0). The total OOWS scores i
Conditions Studied
Interventions
- DRUG Ondansetron
Study Locations (1)
California
- Stanford University School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-11 |
| Est. Completion | 2013-07 |
| Phase | NA |
What the finished NCT01006707 record still lists
NCT01006707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,521-participant average among 58 other Substance-Related Disorders trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Substance-Related Disorders appearing as the primary indexed condition, and to 1 intervention - of which Ondansetron is the first listed.
NCT01006707 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01006707 about?
NCT01006707 is a clinical study titled "Functional Magnetic Resonance Imaging of Opioid Withdrawal in Healthy Human Volunteers". 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. However, we do not know how withdrawal affects the brain. We know that a medic...
What is the current status of trial NCT01006707?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2010-11. Estimated completion is 2013-07.
What conditions does trial NCT01006707 study?
This clinical trial studies the following conditions: Substance-Related Disorders.
What interventions are being tested in trial NCT01006707?
The interventions under investigation include: Ondansetron (DRUG).
Who is sponsoring clinical trial NCT01006707?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01006707 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 NCT01006707's enrollment target sits among peer trials
15 55th of 58 higher than 4 of 58 other Substance-Related Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Substance-Related Disorders 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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