Early Phase 1
N=20
Influence of Medication on Functional Connectivity
Prescription Drug Abuse (Not Dependent)
Bottom Line
View on ClinicalTrials.gov: NCT03612713 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Change in Functional Connectivity Following Oxycodone Administration — 2.66; 4.55; .99; 1.60 z-score
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Oxycodone Medication First (Drug); Placebo First (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Functional Connectivity Following Oxycodone Administration |
2.66; 4.55; .99; 1.60 | — |
Summary
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals
Eligibility Criteria
Inclusion Criteria
- males or females, ages 18-30
- for women of a child-bearing age, acceptable birth control methods or a negative pregnancy test prior to MRI scanning
- ability to provide written, informed consent
- eligibility and willingness to participate in fMRI scanning and to receive oxycodone
- normal weight, as indicated by a body mass index (BMI) between 18.5 to 25
Exclusion Criteria
- current DSM-5 Axis I disorder
- any psychotropic medication or medication known to interfere with metabolism of opioids
- medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician
- known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder
- not eligible for MRI scanning
- positive drug screen
- recent (past 6 months) medical or non-medical opioid-use
- current or previous chronic pain disorder
- significant lifetime use of prescription opioids (>7 days of consecutive medical use or nonmedical use on more than 5 occasions)
Data sourced from ClinicalTrials.gov (NCT03612713). 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.