- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT06442566
TOIMENPITEET: Buprenorfiinin, CBT:n ja TMS:n lisääminen kroonisen kivun pitkäaikaisen opioidihoidon tulosten parantamiseksi (ACTION)
Buprenorfiinin, kognitiivisen käyttäytymishoidon ja transkraniaalisen magneettistimulaation lisäämisen peräkkäinen kokeilu kroonisen kivun pitkäaikaisen opioidihoidon tulosten parantamiseksi (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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 2
- Vaihe 1
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Kelly Barth
- Puhelinnumero: 843-792-0686
- Sähköposti: stephen@musc.edu
Tutki yhteystietojen varmuuskopiointi
- Nimi: Rafael Mendoza
- Sähköposti: mendozra@musc.edu
Opiskelupaikat
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South Carolina
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Charleston, South Carolina, Yhdysvallat, 29407
- Rekrytointi
- Medical University of South Carolina
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Ottaa yhteyttä:
- Rafael Mendoza
- Sähköposti: mendozra@musc.edu
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Ottaa yhteyttä:
- Kelly Barth
- Sähköposti: stephen@musc.edu
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Päätutkija:
- Kelly Barth
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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:
- Taking benzodiazepines with opioids
- 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]
- Dizziness and/or falls
- Difficult-to-manage stomach pain, nausea, constipation or GI issues
- Fatigue or low energy
- Sleepiness or sedation
- Trouble with memory or thinking clearly [COMM Item 1>0]
- 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:
- . Those with nicotine use disorder.
- . 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).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: avoin levy-yhtiö BUP
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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 |
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Active Comparator: Real vs Placebo BUP
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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 |
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Active Comparator: Real vs Sham TMS
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double-blinded randomization to REAL intermittent theta burst (iTBS) rTMS double-blinded randomization to SHAM intermittent theta burst (iTBS) rTMS |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Intervention Tolerability
Aikaikkuna: up to Day-13
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(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
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Pain Severity
Aikaikkuna: up to Day-20
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Buprenorphine Transition Rate
Aikaikkuna: Day-20
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Buprenorphine transition rate defined as the proportion of participants who spontaneously elect to continue buprenorphine after Phase I. |
Day-20
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Quality of Life
Aikaikkuna: up to Day-20
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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
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Pain Interference
Aikaikkuna: up to Day-20
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BPI Interference Scale (lowest score 0, highest 40; higher worse) |
up to Day-20
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Pain Catastrophizing
Aikaikkuna: up to Day-20
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Pain Catastrophizing Scale SF 6 (lowest score 0, highest score 24; higher worse) |
up to Day-20
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Patient Global Impression of Change
Aikaikkuna: up to Day-20
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range 1-7, higher worse |
up to Day-20
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Opioid misuse risk
Aikaikkuna: up to Day-20
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Current opioid Misuse Measure (COMM |
up to Day-20
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Kelly Barth, Medical University of South Carolina
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- Pro00130123
- 1R01DA058620 (Yhdysvaltain NIH-apuraha/sopimus)
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
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