Neuroimmune Effects of Opioid Administration

Completed · Phase 1

Conditions studied: Drug Effect

In brief

Preclinical research indicates acute opioid administration evokes an immune response in the periphery and brain. Here, we will translate those preclinical findings to healthy human volunteers and quantify the neuroimmune response to a morphine challenge using positron emission tomography (PET) imaging with \[11C\]PBR28.

Key facts

Study ID

NCT03801629

Run by

Yale University

People needed

10

Starts

2019-09-12

Expected to finish

2021-03-10

Last updated by the study team

2021-04-27

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women aged between 21 and 50 years (driver's license or valid state ID).
• Physically healthy by medical history, physical, neurological, EKG and laboratory examinations (reviewed by the Study Physician).
• Normal weight, as indicated by a body mass index (BMI) and body weight ≤ 250lbs.
• Read, comprehend, and write English at a sufficient level to complete study-related materials.
• Able to provide voluntary and written informed consent.
• Eligibility and willingness to participate in study procedures, including MRI and PET scanning.
• Previous medical use of opioids without adverse reactions (≥2 lifetime uses).
• Medically eligible to receive up to 0.1 mg/kg deltoid intramuscular morphine (based on medical history, medical exams, and not meeting any exclusion criteria below).
• Medically eligible to receive 10mg of oral metoclopramide based on medical history, medical exams, and current medications.

You may not qualify if…

• Any DSM-5 Axis I disorder diagnosis based on Structured Clinical Interview for DSM-5 (SCID-5), including meeting criteria for substance dependence.
• Any current psychotropic medication use, including MAOI use within the past 14 days
• Recent (past 6 months) medical or non-medical opioid-use.
• Prior medical use prescription opioids for >14 consecutive days (self-report)
• Prior non-medical use of any opioid (i.e., recreational opioid use will be excluded).
• Positive result on a urine drug screen (excluding marijuana).
• Current or previous chronic pain disorder (>6 months of continuous pain).
• 'Low affinity binding' individuals based on rs6971 polymorphism (<10% of the population).
• For females, pregnancy (positive urine test).
• Current use of non-steroidal anti-inflammatory medications or statins.
• Medical contraindication to receive up to 0.1 mg/kg intramuscular morphine administration as determined by Study Physician. This includes:
• known hypersensitivity/allergy to morphine;
• acute or severe bronchial asthma;
• known or suspected gastrointestinal obstruction, including paralytic ileus;
• seizure disorder;
• concomitant use of a benzodiazepine or any other CNS depressant;
• any other significant medical condition, that in the opinion of the Study Physician and Investigators, could: put the patient at risk because of participation in the study, or influence the results of the study, or cause concern about the patient's ability to successfully complete in the study.
• Known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder.
• MRI contraindications, including metal in body (or work in metal/machine shop), pacemaker, claustrophobia, or inability to tolerate MRI scanning.
• Medical contraindications to metoclopramide, as determined by the Study Physician, including:
• known hypersensitivity/allergy to metoclopramide;
• mechanical gastrointestinal obstruction, perforation, or hemorrhage;
• seizure disorder;
• history of tardive dyskinesia;
• or concomitant use of medications/agents likely to increase extrapyramidal reactions.

Where it is running

• Cosgrove Lab — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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