Trial · NCT05463367
Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure
NCT05463367, Phase 2, Active not recruiting, Northwestern University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure. Trials, record NCT05463367. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05463367
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure
- NCT number
- NCT05463367
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Opioid Use, Opioid Dependence, Opioid-use Disorder, Narcotic Use, Back Pain, Back Injuries, Chronic Pain, Chronic Low-back Pain, Pain, Chronic, Pain;Back Low;Chronic, Pain, Back
- Interventions
- Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Naproxen 500 Mg, Opioids
- First posted
- 2022-07-19
- Last updated
- 2024-11-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Differences across drugs in Withdrawal relief assessed by Pain and Craving Index (PCI). | 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). |
| Primary | Differences across drugs in pain changes as assessed by Numeric Rating Scale (0-10). | 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). |
| Secondary | Differences in pain changes (NRS) across High and Low Misuse groups measured by the Current Opioid Misuse Measure (COMM). | 3 weeks | 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) |
| Secondary | Differences in withdrawal changes (PCI) across High and Low Misuse groups measured by the Current Opioid Misuse Measure (COMM). | 3 weeks | 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). |
| Secondary | Whole-cortex multi-receptor related activity | 3 weeks | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05463367
GET https://conductscience.org/api/trials/v1/NCT05463367/registered