Chronic Back PainNCT05203770
Adaptations of the Brain in Chronic Pain With Opioid Exposure I
An observational study of Chronic Back Pain and Opioid Use, run by Northwestern University at 2 sites in United States.
Trial summary
This study investigates brain reorganization and behavioral responses in chronic pain with opioid exposure in Chronic Back Pain (CBP). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Back Pain, Opioid Use
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2018to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects must be 18 years or older. Male and Female No racial/ethnic restrictions General health status: generally good health
Who may be able to join
- 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 have a Visual Analog Scale (VAS) pain score ≥ 40 mm (of 100 mm maximum) at the baseline scanning visit (for which 0mm = no pain, and 100 mm = worst pain imaginable);
- 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;
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- Must have, on average ≥ 4/10 units of pain intensity over the course of a 1-2 week period prior to the brain scanning visit;
- Must be willing to complete daily smartphone/computer app ratings;
- Must be on regular opioid or NSAID therapy for at least 3 months prior to randomization (for opioid and non-opioid treatment groups, respectively), which will be up to the clinical investigator's decision.
Who cannot join
- Low back pain associated with any systemic signs or symptoms, e.g., fever, chills;
- Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
- fibromyalgia, history of tumor in the back;
- Other comorbid chronic pain or neurological conditions;
- Involvement in litigation regarding their back pain or having a disability claim or receiving workman's compensation or seeking either as a result of back pain;
- Diagnosis of current major depression or psychiatric disorder requiring treatment, or such a diagnosis in the previous 6 months;
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- Beck Depression Inventory II score of >28;
- 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 medical disease such as diabetes, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy;
- Uncontrolled hypertension;
- Renal insufficiency;
- Current use of recreational drugs or history of alcohol or drug abuse;
- Any change in medication for back pain in the last 30 days;
- High dose opioid prophylaxis, 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;
- Diabetes (type 1 or type 2);
- Lactose intolerance;
- Allergic reaction to naproxen or any NSAID;
- Any untoward reaction to l-dopa or carbidopa.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
Shirley Ryan Ability Lab
Chicago, Illinois, 60611
About this study
This study investigates brain reorganization and behavioral responses in chronic pain with opioid exposure in Chronic Back Pain (CBP).
Read the detailed description
Chronic back pain (CBP) is the most prevalent chronic pain condition in the US. Opiates are commonly prescribed to treat CBP; as such, these patients are a primary contributor to the current opioid epidemic. This study will assess the impact of opioid use on brain anatomy and function in those subjects taking opioids without opioid misuse disorder, as well as those subjects with opioid misuse disorder, relative to those with CBP and are not taking opioids and healthy controls. This is an observational study, that seeks to establish risk factors and brain biomarkers for opioid misuse disorder and relate brain adaptations to exposure to both opioids and chronic pain. This study also seeks to determine the impact of opioid use on cognitive, emotional, and motor abilities.
- Conditions
- Chronic Back Pain, Opioid Use
- Keywords
- Opioids, Opioid Misuse Disorder, Brain Adaptations, biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CBP+mOUD | Chronic Back pain participants taking opioids and classified in the opioid misuse disorder group | |
| CBP+O | Chronic Back pain participants taking opioids and without opioid misuse disorder group | |
| CBP-O | Chronic Back pain participants not taking opioids | |
| Healthy Controls | Healthy control without pain or taking opioids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine effects of opioid exposure on human brain anatomy and function in CBP using resting-state functional magnetic resonance (fMRI).
We will test the impact of opioid use on brain anatomy and function. For this, all participants will undergo a resting-state functional magnetic resonance (fMRI) exam. Measures of brain anatomy and brain connectivity will be acquired and compared between the observational groups (CBP+O and CBP+mOUD, relative to CBP-O and healthy control). We seek to establish risk factors and brain biomarkers for OUD and relate brain adaptations to exposure to both opioids and chronic pain.
Measured: 1-2 years
To determine cognition, emotion, and motor abilities with opioid exposure in CBP, and to identify associated human brain maladptions.
We will test the impact of opioid use on abilities in CBP+O and CBP+mOUD, relative to CBP-O and healthy controls. For this participants will respond to questionnaires related to their thoughts and feelings.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start31 Oct 2018
- Primary completion23 Feb 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Back PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Apkar Apkarian, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203770
- Sponsor's protocol ID
- STU00207384
- Status last verified
- Mar 2024
- First submitted
- 16 Nov 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptations of the Brain in Chronic Pain With Opioid Exposure I
- ClinicalTrials.gov ID
- NCT05203770
- Acronym / sponsor ID
- STU00207384
- Conditions
- Chronic Back Pain, Opioid Use
- Keywords
- Opioids, Opioid Misuse Disorder, Brain Adaptations, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab, National Institutes of Health (NIH)
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates brain reorganization and behavioral responses in chronic pain with opioid exposure in Chronic Back Pain (CBP).
Detailed description
Chronic back pain (CBP) is the most prevalent chronic pain condition in the US. Opiates are commonly prescribed to treat CBP; as such, these patients are a primary contributor to the current opioid epidemic. This study will assess the impact of opioid use on brain anatomy and function in those subjects taking opioids without opioid misuse disorder, as well as those subjects with opioid misuse disorder, relative to those with CBP and are not taking opioids and healthy controls. This is an observational study, that seeks to establish risk factors and brain biomarkers for opioid misuse disorder and relate brain adaptations to exposure to both opioids and chronic pain. This study also seeks to determine the impact of opioid use on cognitive, emotional, and motor abilities.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CBP+mOUD | – | –Chronic Back pain participants taking opioids and classified in the opioid misuse disorder group |
| CBP+O | – | –Chronic Back pain participants taking opioids and without opioid misuse disorder group |
| CBP-O | – | –Chronic Back pain participants not taking opioids |
| Healthy Controls | – | –Healthy control without pain or taking opioids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects must be 18 years or older. Male and Female No racial/ethnic restrictions General health status: generally good health
Key inclusion criteria (9 listed)
- 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 have a Visual Analog Scale (VAS) pain score ≥ 40 mm (of 100 mm maximum) at the baseline scanning visit (for which 0mm = no pain, and 100 mm = worst pain imaginable);
- 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;
Key exclusion criteria (25 listed)
- Low back pain associated with any systemic signs or symptoms, e.g., fever, chills;
- Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures,
- fibromyalgia, history of tumor in the back;
- Other comorbid chronic pain or neurological conditions;
- Involvement in litigation regarding their back pain or having a disability claim or receiving workman's compensation or seeking either as a result of back pain;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine effects of opioid exposure on human brain anatomy and function in CBP using resting-state functional magnetic resonance (fMRI).
Time frame: 1-2 years
We will test the impact of opioid use on brain anatomy and function. For this, all participants will undergo a resting-state functional magnetic resonance (fMRI) exam. Measures of brain anatomy and brain connectivity will be acquired and compared between the observational groups (CBP+O and CBP+mOUD, relative to CBP-O and healthy control). We seek to establish risk factors and brain biomarkers for OUD and relate brain adaptations to exposure to both opioids and chronic pain.
To determine cognition, emotion, and motor abilities with opioid exposure in CBP, and to identify associated human brain maladptions.
Time frame: 1-2 years
We will test the impact of opioid use on abilities in CBP+O and CBP+mOUD, relative to CBP-O and healthy controls. For this participants will respond to questionnaires related to their thoughts and feelings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Back Pain and Opioid Use, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine effects of opioid exposure on human brain anatomy and function in CBP using resting-state functional magnetic resonance (fMRI). (time frame: 1-2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.