- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02272829
Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain (CHOACOT)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Up to 20% of HIV patients receive prescriptions for chronic opioid therapy (COT) to treat chronic pain. This project will develop a novel collaborative treatment, based on the primary care behavioral consultation model and behavior therapy techniques including motivational interviewing and functional assessment, in which a patient, a Behavioral Health Consultant and a HIV primary care provider share a unified plan targeting misuse of prescribed opioid analgesics in older HIV+ adults. This would be the first theoretically-driven, empirically-tested intervention that specifically attends to the difficult issues around chronic pain and opioid prescription in HIV clinical practice.
This project will develop a collaborative, brief, behavioral consultation intervention targeting misuse of prescribed opioids in older HIV+ adults. The intervention, CHOACOT (Consultation for HIV+ Older Adults on Chronic Opioid Therapy), will consist of:
- three meetings between the Behavioral Health Specialist (BHS) and the patient
- two brief consultations between the BHC and the HIV-PCP
- a joint meeting of the patient, BHC, and HIV-PCP.
To achieve our aims, we will develop CHOACOT beginning with an iterative open trial (n=10). Next, we will conduct a pilot randomized clinical trial (n=30) of CHOACOT versus enhanced Treatment-As-Usual. Opioid misuse will be the primary outcome variable. Quality of the patient-provider relationship, pain, problematic use of other substances, antiretroviral adherence, and psychosocial functioning will be secondary outcomes. The specific aims are:
Aim 1. Develop and refine CHOACOT so that it meets standards of feasibility and acceptability for HIV PCPs, BHCs, and participants;
1a. To develop and field test a CHOACOT BHC manual;
1b. To develop a reliable measure of BHC manual adherence;
1c. To develop and field-test BHC training and supervision procedures. Aim 2. Refine research procedures (e.g., consent and randomization processes, assessment procedures), and establish their feasibility and acceptability to participants while confirming recruitment goal targets.
Misuse of prescribed opioids is the primary outcome. Secondary outcomes are problematic use of substances with a high potential for lethality when used with COT (benzodiazepines, cocaine, alcohol, heroin), ARV adherence, viral load, pain, psychosocial functioning, patient-provider alliance, and treatment satisfaction and acceptability.
This line of work could lead to the incorporation into HIV care of a theoretically-driven and empirically-tested brief intervention for older HIV patients who are prescribed opioids for chronic pain and for whom there is concern about opioid misuse.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02906
- Butler Hospital
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- HIV patients with a physician at the enrollment site;
- Age 50 or older;
- Chronic pain (pain duration for at least six months);
- Daily use of an opioid analgesic, prescribed by an HIV-PCP at the study site, for at least the past 90 days;
- Patients endorse "feeling at risk of losing their pain medication prescription," or that they are "unhappy with how they and their doctors are working together to manage their pain";
- Patient-rated Addictions Behavior Checklist score > 3, as a recommended cut-point indicating opioid misuse.
Exclusion Criteria:
- Current, severe psychiatric symptoms requiring immediate clinical attention;
- Inability to understand English;
- Cognitive impairment severe enough to interfere with ability to actively participate in CHOACOT.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Active
Participants in this arm will receive the study intervention (sessions with the BHC and the PCP).
|
This is an intervention for individuals who use opioid medication for chronic pain, and targets the collaboration between the participant and his/her PCP.
|
|
Comparatore placebo: Health Education
Participants in this arm will receive study sessions about various health topics.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
opioid use
Lasso di tempo: 4 months
|
opioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
|
4 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
quality of the patient-provider relationship
Lasso di tempo: 4 months
|
quality of the patient-provider relationship will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
|
4 months
|
|
pain
Lasso di tempo: 4 months
|
pain will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
|
4 months
|
|
problematic use of other substances
Lasso di tempo: 4 months
|
problematic use of other substances will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
|
4 months
|
|
antiretroviral adherence
Lasso di tempo: 4 months
|
antiretroviral adherences will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
|
4 months
|
|
psychosocial functioning
Lasso di tempo: 4 months
|
psychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
|
4 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Michael Stein, MD, Butler Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Disturbi indotti chimicamente
- Disturbi Correlati a Sostanze
- Dolore
- Manifestazioni neurologiche
- Disturbi correlati agli stupefacenti
- Dolore cronico
- Disturbi correlati agli oppioidi
- Effetti fisiologici delle droghe
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Analgesici
- Agenti del sistema sensoriale
- Narcotici
- Analgesici, oppioidi
Altri numeri di identificazione dello studio
- DA038203
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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