AZIONE: sperimentazione dell'aggiunta di buprenorfina, CBT e TMS per migliorare i risultati della terapia con oppioidi a lungo termine per il dolore cronico (ACTION)
Sperimentazione sequenziale sull'aggiunta di buprenorfina, trattamento cognitivo comportamentale e stimolazione magnetica transcranica per migliorare i risultati della terapia con oppioidi a lungo termine per il dolore cronico (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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Kelly Barth
- Numero di telefono: 843-792-0686
- Email: stephen@musc.edu
Backup dei contatti dello studio
- Nome: Rafael Mendoza
- Email: mendozra@musc.edu
Luoghi di studio
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29407
- Reclutamento
- Medical University of South Carolina
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Contatto:
- Rafael Mendoza
- Email: mendozra@musc.edu
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Contatto:
- Kelly Barth
- Email: stephen@musc.edu
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Investigatore principale:
- Kelly Barth
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: etichetta aperta 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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Comparatore attivo: BUP reale vs placebo
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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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Comparatore attivo: Vero e falso 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Intervention Tolerability
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Buprenorphine Transition Rate
Lasso di tempo: 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
Lasso di tempo: 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
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Pain Interference
Lasso di tempo: up to Day-20
|
BPI Interference Scale (lowest score 0, highest 40; higher worse) |
up to Day-20
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Pain Catastrophizing
Lasso di tempo: 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
Lasso di tempo: up to Day-20
|
range 1-7, higher worse |
up to Day-20
|
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Opioid misuse risk
Lasso di tempo: up to Day-20
|
Current opioid Misuse Measure (COMM |
up to Day-20
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Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Kelly Barth, Medical University of South Carolina
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- Pro00130123
- 1R01DA058620 (Sovvenzione/contratto NIH degli Stati Uniti)
Informazioni su farmaci e dispositivi, documenti di studio
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Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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