Prescription Drug Abuse (Not Dependent)
Conditions
Brief summary
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals
Detailed description
This study will assess the effects of acute low-dose opioid administration on functional neuroimaging measures in healthy individuals (N=40, 20 male, 20 female). The objective of this research is to develop an understanding of factors that may influence individual variability on resting state functional connectivity in response to low-dose opioid administration with the longer term aim of understanding addictions vulnerability. Specifically, the proposed pilot research will explore the effects of single dose of oxycodone (15mg) on resting state functional connectivity and other common neuroimaging measures (e.g., diffusion MRI, structural MRI).
Interventions
DRUGOxycodone Medication First
Participants will be given 15mg oxycodone one hour before fMRI scan. After at least 1 week wash out participants will be given placebo one hour before fMRI scan.
DRUGPlacebo First
Participants will be given placebo one hour before fMRI scan. After at least 1 week wash out participants will be given 15mg oxycodone one hour before fMRI scan.
Sponsors
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
1. males or females, ages 18-30 2. for women of a child-bearing age, acceptable birth control methods or a negative pregnancy test prior to MRI scanning 3. ability to provide written, informed consent 4. eligibility and willingness to participate in fMRI scanning and to receive oxycodone 5. normal weight, as indicated by a body mass index (BMI) between 18.5 to 25
Exclusion criteria
1. current DSM-5 Axis I disorder 2. any psychotropic medication or medication known to interfere with metabolism of opioids 3. medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician 4. known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder 5. not eligible for MRI scanning 6. positive drug screen 7. recent (past 6 months) medical or non-medical opioid-use 8. current or previous chronic pain disorder 9. significant lifetime use of prescription opioids (\>7 days of consecutive medical use or nonmedical use on more than 5 occasions)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Connectivity Following Oxycodone Administration | Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks. | Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity (a statistical relationship between two regions in the brain) between placebo and oxycodone fMRI scans will be assessed. Result is a transformed z-score. A score of 0 indicates no change. Higher scores indicate increased connectivity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxycodone Medication First one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone
Oxycodone Medication First: Participants will be given 15mg oxycodone one hour before fMRI scan. After at least 1 week wash out participants will be given placebo one hour before fMRI scan. | 10 |
| Placebo First one hour before fMRI scan participants will be given a single dose placebo.
Placebo First: Participants will be given placebo one hour before fMRI scan. After at least 1 week wash out participants will be given 15mg oxycodone one hour before fMRI scan. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Oxycodone Medication First | Total | Placebo First |
|---|---|---|---|
| Age, Continuous | 24.20 years STANDARD_DEVIATION 2.82 | 24.30 years STANDARD_DEVIATION 2.81 | 24.40 years STANDARD_DEVIATION 2.95 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 18 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 9 Participants | 6 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 2 / 20 | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Change in Functional Connectivity Following Oxycodone Administration
Functional connectivity is measured by functional magnetic resonance imagery (fMRI). Change in functional connectivity (a statistical relationship between two regions in the brain) between placebo and oxycodone fMRI scans will be assessed. Result is a transformed z-score. A score of 0 indicates no change. Higher scores indicate increased connectivity.
Time frame: Change in functional connectivity from initial fMRI scan to follow-up MRI scan, up to 4 weeks.
Population: Positive and Negative connectivity within the ventral attention network
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxycodone Run | Change in Functional Connectivity Following Oxycodone Administration | Positive network strength for connectivity within the ventral attention network | 2.66 z-score | Standard Deviation 1.37 |
| Oxycodone Run | Change in Functional Connectivity Following Oxycodone Administration | Negative network strength for connectivity within the ventral attention network | .99 z-score | Standard Deviation 0.88 |
| Placebo Run | Change in Functional Connectivity Following Oxycodone Administration | Positive network strength for connectivity within the ventral attention network | 4.55 z-score | Standard Deviation 2.46 |
| Placebo Run | Change in Functional Connectivity Following Oxycodone Administration | Negative network strength for connectivity within the ventral attention network | 1.60 z-score | Standard Deviation 0.54 |