- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06442566
HANDLING: Forsøk med å legge til buprenorfin, CBT og TMS for å forbedre resultatene av langvarig opioidterapi for kronisk smerte (ACTION)
Sekvensiell utprøving av tilsetning av buprenorfin, kognitiv atferdsbehandling og transkraniell magnetisk stimulering for å forbedre resultatene av langsiktig opioidterapi for kronisk smerte (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.
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Kelly Barth
- Telefonnummer: 843-792-0686
- E-post: stephen@musc.edu
Studer Kontakt Backup
- Navn: Rafael Mendoza
- E-post: mendozra@musc.edu
Studiesteder
-
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South Carolina
-
Charleston, South Carolina, Forente stater, 29407
- Rekruttering
- Medical University of South Carolina
-
Ta kontakt med:
- Rafael Mendoza
- E-post: mendozra@musc.edu
-
Ta kontakt med:
- Kelly Barth
- E-post: stephen@musc.edu
-
Hovedetterforsker:
- Kelly Barth
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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:
- 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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: åpen etikett 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kelly Barth, Medical University of South Carolina
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00130123
- 1R01DA058620 (U.S. NIH-stipend/kontrakt)
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