N/A
Completed N=15
Functional Magnetic Resonance Imaging of Opioid Withdrawal in Healthy Human Volunteers
Source: ClinicalTrials.gov NCT01006707 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Brain Regions With Increases or Decreases in Amplitude of Low Frequency Fluctuations (ALFF) Associated With Ondansetron Administration — 0.519; 0.562; 0.478; 0.486 correlation coefficient
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Regions With Increases or Decreases in Amplitude of Low Frequency Fluctuations (ALFF) Associated With Ondansetron Administration |
0.519; 0.562; 0.478; 0.486; -0.612; 0.475 | — |
| SECONDARY Objective Opioid Withdrawal Scale Score 5 Minutes Following Ondansetron or Placebo Administration |
1; 2 | 0.042 sig |
| SECONDARY Objective Opioid Withdrawal Scale Score 15 Minutes Following Ondansetron or Placebo Administration |
2.7; 2.2 | 0.322 |
| SECONDARY Subjective Opioid Withdrawal Scale (SOWS) Score 20 Minutes Following Ondansetron or Placebo Administration |
5.7; 8.1 | 0.261 |
Eligibility Criteria
Inclusion Criteria
- Patients will be healthy male volunteers, ages 18-35.
Exclusion Criteria
- Females were excluded due to menstrual cycle modulation of opioid response.
- We will exclude individuals with Raynaud's disease or a history of coronary artery disease.
Data sourced from ClinicalTrials.gov (NCT01006707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.