Trial · NCT06367387
Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment
NCT06367387, Phase 4, Completed, Erin Winstanley
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment. Trials, record NCT06367387. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06367387
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pain Self-Management and Patient-Oriented Dosing for Pain and in Retention Opioid Treatment
- NCT number
- NCT06367387
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 273 participants, actual
- Lead sponsor
- Erin Winstanley
- Conditions
- Opioid Use Disorder, Chronic Pain
- Interventions
- Patient-Oriented Dosing (POD), Pain Self-Management (PSM), Usual Care, Standard Buprenorphine Dosing Condition
- First posted
- 2024-04-16
- Last updated
- 2026-11-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in Pain Interference as Assessed by the PROMIS SF v1.0 - Pain Interference 4a at 3 months Post-baseline | Baseline, 3 Months | The PROMIS Pain Interference - Short Form 4a is a validated, self-report 4-item tool assessing pain interference over the past 7 days. The PROMIS SF v1.0 - Pain Interference 4a consists of 4 questions and uses a 5-point scale, ranging from 1 (not at all) to 5 (very much). The total raw score equals the sum the values of the response to each question. The raw score is converted to a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like pain interference, a T-score of 60 is one SD worse than average. That is, a person has more problems with pain hindering activities. By comparison, a pain interference T-score of 40 is one SD better than average. Change = 3 month score - baseline score |
| Secondary | Change from Baseline in Overall Pain as Assessed by the PEG at 3 months Post-baseline | Baseline, 3 Months | The Pain, Enjoyment, and General Activity (PEG) Scale is a validated, self-report 3-item tool assessing pain intensity and interference over the past week. The PEG scale consists of 3 separate numerical scales. Each scale has ratings ranging from 0-10. The PEG score is calculated by averaging the three numbers; a higher score indicates greater pain. Change = 3 month score - baseline score |
| Secondary | Change from Baseline in Pain Catastrophizing as Assessed by the Pain Catastrophizing Questionnaire-6-item at 3 months Post-baseline | Baseline, 3 Months | The Pain Catastrophizing Scale is a validated, self-report 6-item tool assessing assess pain catastrophizing for chronic pain. The PCS-6 uses a 5-point scale, ranging from 0 (not at all) to 4 (all the time). The total score ranges from 0 to 24, with higher score representing greater catastrophic thinking. Change = 3 month score - baseline score |
| Secondary | Proportion of Participants Retained in buprenorphine Treatment at 3 months Post-baseline | 3 Months | Proportion retained is defined as # completed visits divided by # scheduled visits |
| Secondary | Proportion of Participants Taking any MOUD at 3-, 6-, 9- and 12-months Post-baseline | 3 Months, 6 Months, 9 Months, 12 Months | Measured by self-report and medical chart extraction |
| Secondary | Change from Baseline in Self-efficacy as Assessed by the PROMIS Self-Efficacy for Managing Symptoms SF-4a at 3 months Post-baseline | Baseline, 3 Months | The PROMIS Self-Efficacy for Managing Symptoms - Short Form 4a is a validated, self-report 4-item tool assessing current level of confidence to managing symptoms in relation to a chronic condition. The PROMIS SF v1.0 - Pain Interference 4a consists of 4 questions and uses a 5-point scale, ranging from 1 (I am not confident at all) to 5 ( I am very confident). The total raw score equals the sum the values of the response to each question. The raw score is converted to a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. A higher PROMIS T-score represents more of the concept being measured. For example, a T-score of 55 on the PROMIS Self-Efficacy for Managing Emotions indicates that the respondent has greater self-efficacy for managing their emotions than the general chronic condition population (i.e., half a standard deviation higher). Change = 3 month score - baseline score |
| Secondary | Number of Days Non-prescribed Opioids were Used in the past 30 days as Assessed by the Modified ASI at 3-months Post-baseline | 3 Months | The modified ASI is a validated, self-report tool which includes questions from the Addiction Severity Index section on drug and alcohol use and includes questions about specific opioids used. The number of days in the last 30 that a participant reports using heroin, fentanyl, and/or opioid analgesics (percocet, oxycodone, oxycontin, vicodin, dilaudid, hydrocodone, hydromorphone, morphine, or codeine) will be summed for the outcome "Number of days non-prescribed opioids were used in the past 30 days." Number of days may range from 0 to 90. |
| Secondary | Total score on the IMPOWR Opioid Misuse Screening scale at 3 months Post-baseline | 3 Months | The IMPOWR Opioid Misuse Screening scale is an exploratory, self-report scale consisting of 4 questions about the use of prescribed pain medications. Each question response ranges from Never (0) to Almost Always (4) with a possible summed score ranging from 0 to 16, with higher scores indicating more severe misuse. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38907678 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| RM1DA055311 | Tailored Retention and Engagement for Effective integrated Treatment of OUD and Pain (TREETOP) | WINSTANLEY, ERIN L; HAMM, MEGAN; MERLIN, JESSICA S | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE ON DRUG ABUSE | 2021 to 2025 |
Source NIH RePORTER
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT06367387
GET https://conductscience.org/api/trials/v1/NCT06367387/registered