Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to track brain functional changes in individuals with i) chronic back pain + opioid use (CBP+O) and individuals with ii) chronic back pain + opioid misuse disorder (CBP+mOUD) following a brief drug delay and re-exposure manipulation. Re-exposure could be placebo, the participant's own opioid dose, or a dopaminergic treatment (DA+NSAID). The participants will be also evaluated for changes in cognition, emotion, and motor abilities with opioid delay and re-exposure to placebo, opioid, or DA+NSAID.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborators: National Institutes of Health (NIH); Shirley Ryan AbilityLab
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Carbidopa; Carbidopa, levodopa drug combination; Codeine; Hydrocodone; Levodopa; Morphine; Naproxen; Oxycodone; Oxymorphone; Tramadol

Criteria

Inclusion Criteria:

• History of low back pain for a minimum of 6 months daily (prior to screening), meeting the Quebec Task Force Classification System symptom categories I-III;

• Male or female, age equal or greater than 18 years, with no racial/ethnic restrictions;

• Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires;

• Must be in generally stable health;

• Must sign an informed consent document after a complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits and potential risks, and are willing to participate;

• Must have, on average ≥ 4/10 units of pain intensity over the course of a 1-4 week period prior to the brain scanning visit;

• Must be willing to complete daily smartphone/computer eDiary ratings;

• Must be on regular opioid therapy or for at least 3 months prior to randomization which will be up to the clinical investigator's decision

• Must be on a short acting opioid therapy (anticipated duration of action < 6 hours)

Exclusion Criteria:

• Low back pain associated with any systemic signs or symptoms, e.g., fever, chills;

• Other comorbid chronic pain or neurological conditions;

• Use of therapeutic doses of antidepressant medications at unstable doses (i.e., tricyclic depressants, SSRIs, SNRIs; low doses used for sleep may be allowed);

• Significant other unstable medical disease such as diabetes, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy;

• Uncontrolled hypertension;

• Renal insufficiency;(correlated creatinine clearance < 40mL/min or serum creatinine ≥2)

• Daily use of high doses of opioids,, as defined as > 50mg morphine equivalent/day;

• Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;

• In the judgment of the investigator, unable or unwilling to follow protocol and instructions;

• Evidence of poor treatment compliance, in the judgment of the investigator;

• Intra-axial implants (e.g. spinal cord stimulators or pumps);

• All exclusion criteria for MR safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia;

• Pregnancy, or inability to use an effective form of contraception in women of child-bearing age;

• An established diagnosis of diabetes (type 1 or type 2)

• Lactose intolerance

• History of an allergic reaction to naproxen or any NSAID;

• History of any untoward reaction to carbidopa/levodopa

• Use of a patch or long acting opioid therapy (e.g. anticipated duration of action > 6 hours)