- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02272829
Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain (CHOACOT)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Rhode Island
-
Providence, Rhode Island, Estados Unidos, 02906
- Butler Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
|
Comparador de placebos: Health Education
Participants in this arm will receive study sessions about various health topics.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
opioid use
Periodo de tiempo: 4 months
|
opioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
|
4 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
quality of the patient-provider relationship
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 4 months
|
psychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
|
4 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michael Stein, MD, Butler Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos inducidos químicamente
- Trastornos relacionados con sustancias
- Dolor
- Manifestaciones neurológicas
- Trastornos relacionados con narcóticos
- Dolor crónico
- Trastornos relacionados con opioides
- Efectos fisiológicos de las drogas
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Estupefacientes
- Analgésicos Opiáceos
Otros números de identificación del estudio
- DA038203
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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