Trial · NCT06442566
ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
NCT06442566, Phase 1, Phase 2, Recruiting, Medical University of South Carolina
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain. Trials, record NCT06442566. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06442566
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ACTION: Trial of Adding Buprenorphine, CBT, and TMS to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain
- NCT number
- NCT06442566
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 240 participants, estimated
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Opioid Withdrawal, Chronic Pain
- Interventions
- Buprenorphine Patch, Placebo, Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation (TMS)
- First posted
- 2024-06-04
- 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 | Intervention Tolerability | up to Day-13 | (a) Tolerability of open-label transdermal buprenorphine, defined as the proportion of eligible patients who do not discontinue buprenorphine due to adverse effects, preference, or intolerance. (b) Tolerability of TMS/sham, defined as tolerating 10 sessions of accelerated rTMS |
| Primary | Pain Severity | up to Day-20 | Pain severity is measured by the Brief Pain Inventory (BPI) Severity Scale and is typically scored as the mean of the four severity items ("average," "worst," "least," "now," range 0-10) with a higher score being worse. This outcome will be measured after both the buprenorphine vs. placebo trial and the TMS vs. sham trial. |
| Secondary | Buprenorphine Transition Rate | Day-20 | Buprenorphine transition rate defined as the proportion of participants who spontaneously elect to continue buprenorphine after Phase I. |
| Secondary | Quality of Life | up to Day-20 | Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) score summarizes multiple domains into a single score anchored at 0 (as bad as dead) and 1 (perfect or ideal health). This score quantifies the value that individuals place on different states of health. PROPr is calculated from the scores for the 7 PROMIS domains: Cognition, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. This outcome will be measured after both the buprenorphine vs. placebo trial and the TMS vs. sham trial. |
| Secondary | Pain Interference | up to Day-20 | BPI Interference Scale (lowest score 0, highest 40; higher worse) |
| Secondary | Pain Catastrophizing | up to Day-20 | Pain Catastrophizing Scale SF 6 (lowest score 0, highest score 24; higher worse) |
| Secondary | Patient Global Impression of Change | up to Day-20 | range 1-7, higher worse |
| Secondary | Opioid misuse risk | up to Day-20 | Current opioid Misuse Measure (COMM |
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.
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 |
|---|---|---|---|---|---|
| R01DA058620 | Sequential Trial of Adding Buprenorphine, Cognitive Behavioral Treatment, and Transcranial Magnetic Stimulation to Improve Outcomes of Long-Term Opioid Therapy for Chronic Pain (ACTION) | BARTH, KELLY S.; BORCKARDT, JEFFREY J | MEDICAL UNIVERSITY OF SOUTH CAROLINA | NATIONAL INSTITUTE ON DRUG ABUSE | 2023 |
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/NCT06442566
GET https://conductscience.org/api/trials/v1/NCT06442566/registered