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New study combines three therapies to help chronic pain patients on opioids

NCT ID NCT06442566

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing three treatments one after another for people with chronic pain who are already taking long-term opioids. First, participants try a low-dose buprenorphine patch (a safer opioid) without going through withdrawal. Then, they receive a brief cognitive behavioral therapy program for pain. Finally, some get a type of brain stimulation called TMS. The goal is to see if these steps can reduce pain, improve quality of life, and lower the risks of opioid use. The study involves 240 adults and will follow them for up to a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
buprenorphine patch, cognitive behavioral therapy, and transcranial magnetic stimulation (TMS)
What this could lead to
If successful, this could offer safer, more effective ways to manage chronic pain while reducing dependence on high-dose opioids.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 240 participants, so results may not apply broadly. The interventions may cause side effects or not improve pain enough to justify changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: Age \>/= 18 years English-speaking On LTOT, defined as taking daily prescription opioid therapy for 90 days or more Past week average morphine equivalent dose (MED) \>/= 20mg Willing and able to complete written informed consent Willing and able to use a mobile/cell phone Have at least one additional risk for opioid toxicity or overdose from the following list: Opioid Toxicity or Overdose Risks: 1. Taking benzodiazepines with opioids 2. Substance Use Disorder diagnosis \[non-tobacco; Opioid Risk Tool\] 2\) Having ever experienced an overdose 4) Current major medical problem \[e.g. mod-severe liver disease, pancreatitis, chronic pulmonary disease, untreated sleep apnea, hospitalized for an acute medical issue in the past 6 months\]a,b 5) Response to BPI Item 8 \<30%, suggesting less than moderately clinically meaningful response to pain treatmentc 6) Co-morbid psychiatric diagnosis \[Opioid Risk Tool\] 7) Signs of opioid misuse \[any score \>0 on the following COMM Items: 3,4,5,9,10,11,14,15,16\] 8)Opioid Risk Tool \>3 or Current Opioid Misuse Measure ≥ 9 9) Struggling with any of the following side effects from opioids \[self-report\] 1. Dizziness and/or falls 2. Difficult-to-manage stomach pain, nausea, constipation or GI issues 3. Fatigue or low energy 4. Sleepiness or sedation 5. Trouble with memory or thinking clearly \[COMM Item 1\>0\] 6. Other troublesome side effect \[open answer\] Exclusion criteria: Known allergy to buprenorphine Active moderate or severe substance use disorder with the exception of those listed below: 1. . Those with nicotine use disorder. 2. . Those meeting criteria for prescription opioid use disorder using only prescribed opioids will be considered on a case-by-case basis. Cognitive disorder limiting ability to consent or fully participate in the brief cognitive intervention Receiving methadone or buprenorphine treatment for OUD or pain Taking naltrexone Pregnancy Currently incarcerated Taking medications that prolong QTc interval, as determined by study investigators Personal/immediate family history of Long QT Syndrome. Significant or unstable condition/s or treatments that may impact safe participation in the study (as determined by the study investigators) such as significant cardiac condition (e.g. poorly-controlled heart failure, current or past cardiac arrhythmia, sustained systolic blood pressure \>180), significant metabolic disorder (e.g. labile diabetes, significant electrolyte abnormality), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), major psychiatric disorder (e.g. active bipolar disorder, schizophrenia spectrum or other psychotic disorder, suicidal/homicidal intent within the past month, or any suicide attempts within the past year or current active suicidal ideation, as determined by medical clinician), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. movement disorder, multiple sclerosis, moderate to severe brain injury). Enrolled in a clinical trial or has received an investigational medication or device in the last 30 days. TMS contraindications (e.g., ferromagnetic implants, conditions or treatments that lower seizure threshold, taking contraindicated medications, no identifiable motor threshold, as determined by study investigators).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29407, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.