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HANDLING: Forsøg med at tilføje buprenorphin, CBT og TMS for at forbedre resultaterne af langsigtet opioidterapi for kroniske smerter (ACTION)

2. november 2026 opdateret af: Medical University of South Carolina

Sekventielt forsøg med tilføjelse af buprenorphin, kognitiv adfærdsbehandling og transkraniel magnetisk stimulering for at forbedre resultaterne af langvarig opioidterapi for kroniske smerter (ACTION)

This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) "accelerated" rTMS over the left dorsolateral prefrontal cortex, by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at 4-, 12-, 24- and 52-week follow-up.

Studieoversigt

Detaljeret beskrivelse

With little evidence available to guide the provision of clinical care for patients on long-term opioid therapy (LTOT) in whom the risks outweigh the benefits, major questions remain about optimizing the risk/benefit profile of LTOT, including: how to best engage patients voluntarily in this process; the safety, tolerability and effectiveness of newer treatment approaches; and optimal treatment selection. The primary objective of the proposed study is to begin to systematically address gaps in this important area to improve pain, reduce risk, and improve quality of life for individuals on LTOT.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

240

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29407
        • Rekruttering
        • Medical University of South Carolina
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Kelly Barth

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria:

Age >/= 18 years

English-speaking

On LTOT, defined as taking 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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: åben etiket BUP

Buprenorphine patch dosing will be individualized based on each participant's current morphine-equivalent dose (per package insert/recommendations; between 5mcg and 20mcg per hour). Dosage based on baseline MEQ (<30 MEQ = 5mcg/hr patch, 30-80 MEQ =10-15mcg/hour patch; >80 MEQ = 20mcg/hour patch), which will remain on for 7 days (Phase Ia Days 1-7), as tolerated

Aktiv komparator: Real vs Placebo BUP

Buprenorphine patch dosing will be individualized based on each participant's current morphine-equivalent dose (per package insert/recommendations; between 5mcg and 20mcg per hour). Dosage based on baseline MEQ (<30 MEQ = 5mcg/hr patch, 30-80 MEQ =10-15mcg/hour patch; >80 MEQ = 20mcg/hour patch), which will remain on for 7 days (Phase Ia Days 1-7), as tolerated

double-blinded randomization to placebo or transdermal buprenorphine

Aktiv komparator: Real vs Sham TMS

double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS

double-blinded randomization to SHAM intermittent theta burst (iTBS) rTMS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intervention Tolerability
Tidsramme: 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

up to Day-13
Pain Severity
Tidsramme: 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.

up to Day-20

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Buprenorphine Transition Rate
Tidsramme: Day-20

Buprenorphine transition rate defined as the proportion of participants who spontaneously elect to continue buprenorphine after Phase I.

Day-20
Quality of Life
Tidsramme: 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.

up to Day-20
Pain Interference
Tidsramme: up to Day-20

BPI Interference Scale (lowest score 0, highest 40; higher worse)

up to Day-20
Pain Catastrophizing
Tidsramme: up to Day-20

Pain Catastrophizing Scale SF 6 (lowest score 0, highest score 24; higher worse)

up to Day-20
Patient Global Impression of Change
Tidsramme: up to Day-20

range 1-7, higher worse

up to Day-20
Opioid misuse risk
Tidsramme: up to Day-20

Current opioid Misuse Measure (COMM

up to Day-20

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Kelly Barth, Medical University of South Carolina

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. august 2024

Primær færdiggørelse (Anslået)

31. marts 2028

Studieafslutning (Anslået)

31. marts 2029

Datoer for studieregistrering

Først indsendt

29. maj 2024

Først indsendt, der opfyldte QC-kriterier

29. maj 2024

Først opslået (Faktiske)

4. juni 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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