Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure
NCT ID: NCT05463367
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2021-01-01
2025-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants that have participated in Project 1 Aim 1 within three months of consenting to Project 1 Aim 2 will not require a screening visit and can continue on to Visit 1, 2 and 3 of Aim 2.
A screening visit will be applicable for those participants that did not participate in Project 1 Aim 1, and for those that had participated but did so more than three months prior to consenting to Project 1 Aim 2.
Participants will be evaluated with inclusion/exclusion criteria and complete the informed consent. A medical/pain history will be taken and a physical exam will be completed by a physician. Participants will complete a number of questionnaires assessing health and medical history, past and current pain levels, and personality. Participants will have their blood drawn to confirm appropriate kidney and liver function (investigators will take \~40mL of blood). Participants will also be asked to provide a urine sample to confirm if any illicit drugs are in their system.
Participants will also be instructed to report their pain and craving ratings via an application that will be downloaded on their device. They will need to complete two ratings per day that they are involved in the study.
Visit 1, 2, and 3 (6-8 hours):
Participants will be instructed to not take their morning opioid medication. Upon arrival, participants will be asked to report their pain and craving using the Pain and Craving Index (PCI), which will be used as a baseline rating. They will complete the PCI once every hour throughout their visit. Once their PCI has increased by at least two-points from their baseline rating, the patient will undergo their first brain MRI scan (anatomical and functional scans).
Between arrival and the first MRI, participants will complete several questionnaires regarding pain, mood, thoughts, and feelings. Directly after the MRI, participants will have their blood drawn. This blood draw will be used to quantitatively analyze the participants' opioid levels. Participants will then complete the NIH Toolbox. The NIH Toolbox is a compilation of activities that evaluate different cognitive, motor and emotional functions.
Participants will then be randomized and receive "Treatment Dose #1." Treatment dose #1 will be one of the following: a single dose of the participant's opioid prescription (provided by Northwestern Memorial Hospital's investigational pharmacy), carbidopa/levodopa (c-dopa/l-dopa), or placebo (lactose). Participants will then complete the same questionnaires as they previously had, undergo a second brain MRI scan, have their blood drawn, and complete a second NIH Toolbox.
Participants will then receive "Treatment Dose #2." For those participants that received their opioid medication for treatment dose #1, they will receive placebo for their treatment dose #2. For those participants that received carbidopa/levodopa or placebo for treatment dose #1, they will receive their opioid prescription for their treatment dose #2.
After receiving treatment dose #2, participants will be done with their imaging visit.
Each participant will have three total imaging visits. The activities within each imaging visit will be identical, the only variable will be the study intervention (opioid, c-dopa/l-dopa, or placebo) that they receive. All participants will receive each of the possible study interventions; however, the sequence of when they will receive each drug will be different from participant to participant. Neither participants nor the clinical coordinator/assistant will know which intervention the participant is receiving.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
Recruitment is completed. Of the collected subjects with opioid exposure none exhibited opioid misuse.
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Chronic Back Pain with Opioid Use
Subjects of this arms will be on a previously prescribed, short term acting opioid. Previous to each of the three imaging visits, subjects will be instructed to withhold from taking their regular morning opioid dose. Subjects will be randomized into a group that determines the sequence of which they will receive the study drugs. The three sequences are as follows:
1. treatment dose #1: 25mg carbidopa/ 100mg levodopa + 500mg naproxen, treatment dose #2: subjects prescribed, short acting opioid;
2. treatment dose #1: placebo, treatment dose #2: subjects prescribed, short acting opioid; or
3. treatment #1: subjects prescribed, short acting opioid, treatment dose #2: placebo.
Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet
Subjects will receive a single dose of carbidopa/levodopa, when applicable.This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.
Naproxen 500 Mg
Subjects will receive a single dose of naproxen 500mg alongside carbidopa/levodopa, when applicable.This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.
Opioids
Subjects will be pre-screened in regards to their opioid medication. They will receive a single dose of their opioid dose, when appropriate. This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.
Chronic Back Pain with Opioid Misuse Disorder
Subjects of this arms will be on a previously prescribed, short term acting opioid. Previous to each of the three imaging visits, subjects will be instructed to withhold from taking their regular morning opioid dose. Subjects will be randomized into a group that determines the sequence of which they will receive the study drugs. The three sequences are as follows:
1. treatment dose #1: 25mg carbidopa/ 100mg levodopa + 500mg naproxen, treatment dose #2: subjects prescribed, short acting opioid;
2. treatment dose #1: placebo, treatment dose #2: subjects prescribed, short acting opioid; or
3. treatment #1: subjects prescribed, short acting opioid, treatment dose #2: placebo.
Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet
Subjects will receive a single dose of carbidopa/levodopa, when applicable.This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.
Naproxen 500 Mg
Subjects will receive a single dose of naproxen 500mg alongside carbidopa/levodopa, when applicable.This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.
Opioids
Subjects will be pre-screened in regards to their opioid medication. They will receive a single dose of their opioid dose, when appropriate. This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet
Subjects will receive a single dose of carbidopa/levodopa, when applicable.This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.
Naproxen 500 Mg
Subjects will receive a single dose of naproxen 500mg alongside carbidopa/levodopa, when applicable.This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.
Opioids
Subjects will be pre-screened in regards to their opioid medication. They will receive a single dose of their opioid dose, when appropriate. This will be double-blinded, as neither participants nor study staff will know what medication the participant is receiving.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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);
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shirley Ryan AbilityLab
OTHER
National Institutes of Health (NIH)
NIH
Northwestern University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Apkar Apkarian
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Apkar V Apkarian, PhD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University Feinberg School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STU00209670
Identifier Type: -
Identifier Source: org_study_id