Opioid UsePhase 2NCT05463367
Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure
A Phase 2 study testing Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Naproxen 500 Mg and Opioids in people with Opioid Use and Opioid Dependence, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Opioid Dependence, Opioid-use Disorder
- What is being tested?
- Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Naproxen 500 Mg and Opioids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Jun 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
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 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;
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- 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)
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
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.
Read the detailed description
Screening Visit (2-3 hours) (if applicable):
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
- Opioid Use, Opioid Dependence, Opioid-use Disorder, Narcotic Use, Back Pain, Back Injuries
- Being tested
- Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Naproxen 500 Mg, Opioids
- Keywords
- norco, opioid, pain medication, tramadol, oxycodone, pain, chronic pain, chronic back pain, back pain, narcotics
- Medical subject headings
- Opioid-Related Disorders, Back Pain, Back Injuries, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbidopa-Levodopa 25 Mg-100 Mg Oral TabletDrug
Also called Sinemet
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 MgDrug
Also called Aleve, Anaprox, Antalgin, Midol Extended Relief
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.
OpioidsDrug
Also called hydrocodone/acetaminophen, oxycodone/acetaminophen, oxycodone, oxymorphone
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Back Pain with Opioid Use | Experimental | 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. Receives: Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet; Drug: Naproxen 500 Mg; Drug: Opioids |
| Chronic Back Pain with Opioid Misuse Disorder | Experimental | 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. Receives: Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet; Drug: Naproxen 500 Mg; Drug: Opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences across drugs in Withdrawal relief assessed by Pain and Craving Index (PCI).
Pain and Drug craving Index (PCI) will be used to evaluate self-reported medication cravings. Participants will complete the scale, before and after receiving the visit drug treatment. Changes in PCI scores (after minus before) will be compared between drugs (opioids vs. placebo vs. Carbidopa/Levodopa +naproxen).
Measured: 3 weeks
Differences across drugs in pain changes as assessed by Numeric Rating Scale (0-10).
NRS scale will be used to evaluate self-reported pain. Participants will rate their pain before and after receiving the visit drug treatment. Changes in pain scores (after minus before) will be compared between drugs (opioids vs. placebo vs. Carbidopa/Levodopa +naproxen).
Measured: 3 weeks
Secondary outcomes (3)
Differences in pain changes (NRS) across High and Low Misuse groups measured by the Current Opioid Misuse Measure (COMM).
Current Opioid Misuse Measure (COMM) is a 17-item self-report measure of risk for aberrant medication-related behavior among persons with chronic pain who are prescribed opioids for pain. Participants will be divided into two groups: high COMM and low COMM. Changes in pain scores (after minus before) will be compared between COMM groups (high vs. low)
Measured: 3 weeks
Differences in withdrawal changes (PCI) across High and Low Misuse groups measured by the Current Opioid Misuse Measure (COMM).
Current Opioid Misuse Measure (COMM) is a 17-item self-report measure of risk for aberrant medication-related behavior among persons with chronic pain who are prescribed opioids for pain. Participants will be divided into two groups: high COMM and low COMM. Changes in Withdrawal relief - PCI score (after minus before) will be compared between COMM groups (high vs. low).
Measured: 3 weeks
Whole-cortex multi-receptor related activity
We used the resting-state fMRI to generate whole-brain voxel-wise amplitude of low-frequency fluctuations (ALFF) maps that reflect the low-frequency energy of spontaneous BOLD activity. Cortex-wide receptor-related activity for each subject will be computed as the normalized dot product between ALFF maps and the standardized receptor density distribution maps obtained from Hensen et al 2022. This will result in one value per subject representing cortical receptor-related activity for any given receptor type. For this analysis we will focus on 3 receptors that we have shown to be modulated in long-term opioid use including the serotonin (5-HT1A and 5-HT1B) receptors and the µ-opioid (MOR) receptor. We will also investigate both dopamine (D1 and D2) receptors to test their modulation with administering dopamine+NSAID.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Jan 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There will be 2 arms of participants, those who have back pain with opioid exposure, and those who have back pain with opioid exposure and opioid misuse disorder. Each participant, regardless of the arm that they are in, will receive each of the possible study interventions. The only difference will be the order of which they receive each interventions. Recruitment is completed. Of the collected subjects with opioid exposure none exhibited opioid misuse.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
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
- Investigators
- Apkar V Apkarian, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463367
- Sponsor's protocol ID
- STU00209670
- Status last verified
- Nov 2024
- First submitted
- 27 Feb 2020
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure
- ClinicalTrials.gov ID
- NCT05463367
- Acronym / sponsor ID
- STU00209670
- Conditions
- Opioid Use, Opioid Dependence, Opioid-use Disorder, Narcotic Use, Back Pain, Back Injuries
- Keywords
- norco, opioid, pain medication, tramadol, oxycodone, pain, chronic pain, chronic back pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab, National Institutes of Health (NIH)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 19 Jul 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 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.
Detailed description
Screening Visit (2-3 hours) (if applicable):
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- There will be 2 arms of participants, those who have back pain with opioid exposure, and those who have back pain with opioid exposure and opioid misuse disorder. Each participant, regardless of the arm that they are in, will receive each of the possible study interventions. The only difference will be the order of which they receive each interventions. Recruitment is completed. Of the collected subjects with opioid exposure none exhibited opioid misuse.
| Arm | Type | Receives |
|---|---|---|
| Chronic Back Pain with Opioid Use | Experimental | Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Drug: Naproxen 500 Mg, Drug: OpioidsSubjects 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. |
| Chronic Back Pain with Opioid Misuse Disorder | Experimental | Drug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Drug: Naproxen 500 Mg, Drug: OpioidsSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbidopa-Levodopa 25 Mg-100 Mg Oral TabletAlso: SinemetSubjects 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. | Drug | Chronic Back Pain with Opioid Misuse Disorder, Chronic Back Pain with Opioid Use |
| Naproxen 500 MgAlso: Aleve, Anaprox, Antalgin, Midol Extended ReliefSubjects 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. | Drug | Chronic Back Pain with Opioid Misuse Disorder, Chronic Back Pain with Opioid Use |
| OpioidsAlso: hydrocodone/acetaminophen, oxycodone/acetaminophen, oxycodone, oxymorphoneSubjects 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. | Drug | Chronic Back Pain with Opioid Misuse Disorder, Chronic Back Pain with Opioid Use |
Primary outcome
Differences across drugs in Withdrawal relief assessed by Pain and Craving Index (PCI).
Time frame: 3 weeks
Pain and Drug craving Index (PCI) will be used to evaluate self-reported medication cravings. Participants will complete the scale, before and after receiving the visit drug treatment. Changes in PCI scores (after minus before) will be compared between drugs (opioids vs. placebo vs. Carbidopa/Levodopa +naproxen).
Differences across drugs in pain changes as assessed by Numeric Rating Scale (0-10).
Time frame: 3 weeks
NRS scale will be used to evaluate self-reported pain. Participants will rate their pain before and after receiving the visit drug treatment. Changes in pain scores (after minus before) will be compared between drugs (opioids vs. placebo vs. Carbidopa/Levodopa +naproxen).
3 secondary outcomes
Differences in pain changes (NRS) across High and Low Misuse groups measured by the Current Opioid Misuse Measure (COMM).
Time frame: 3 weeks
Differences in withdrawal changes (PCI) across High and Low Misuse groups measured by the Current Opioid Misuse Measure (COMM).
Time frame: 3 weeks
Whole-cortex multi-receptor related activity
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 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.
Apkar V Apkarian, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Naproxen 500 Mg and Opioids in people with Opioid Use and Opioid Dependence, run by Northwestern University at 1 site 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 18 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: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Differences across drugs in Withdrawal relief assessed by Pain and Craving Index (PCI). (time frame: 3 weeks). 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 27 Nov 2024.