- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01733693
Neurocognitive Effects of Opiate Agonist Treatment (NEO)
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
After randomization, each medication will be prescribed and administered by one of these experienced clinicians, according to well- established national protocols. Participants will be randomized in a 1:1 ratio in variable size blocks of 4-8 via central, computer-generated randomization. Given the relatively small sample size, we will randomize in blocks to ensure comparison groups of approximately equal size. Because medication type will not be blinded, we will vary block size to prevent anticipation of treatment arm assignment. We will also stratify randomization by HIV status to ensure equal numbers of HIV-infected persons in each arm.
INTERVENTION DOSE. Doses of buprenorphine and methadone will be adjusted within pre-specified ranges to ensure that comparisons between the two treatments are based on individually optimized doses.
Buprenorphine (we will use the buprenorphine/naloxone combination exclusively) will be administered at a dose of 8 to 32 mg per day, though we expect most subjects not to exceed 24 mg per day. These doses approximate methadone doses of 60 to 100 mg daily, which are in the upper range of doses generally used in clinical practice, but are well-known to be most efficacious and are also most prevalent in DoSA. Since study clinicians will be experienced substance abuse treatment providers, some flexibility will be allowed within these parameters. Both buprenorphine and methadone will be administered daily as oral medications.
The study will have two phases: induction/stabilization (weeks 1 - 3) and maintenance (weeks 4 - 24).
During dose induction/stabilization, subjects will attend daily visits (Sx/week) with a study clinician and receive gradually increasing doses of medication (see below). The first week of induction/stabilization will be considered a run-in period; at the conclusion of this week participants will complete enrollment in the trial and also complete their first NP research visit. The purpose of the run-in period is to ensure that we enroll persons who are able to comply with all trial requirements.
MAINTENANCE PHASE. The maintenance stage of opioid pharmacotherapy begins when a patient is responding optimally to medication treatment and routine dosage adjustments are no longer needed. Patients at this stage have stopped abusing opioids and many remain on the same dosage of treatment medication for many months, whereas others require frequent or occasional adjustments. During maintenance (starting on day 22, week 4),subjects in both arms will attend the clinic three times per week, on Monday, Wednesday, and Friday, and will receive bottles of medication to take home for the other four days of the week. Subjects will receive increases in their doses starting in week 4 if they meet pre-established criteria, up to 100 mg of methadone, and up to 32 mg of buprenorphine.
Our proposed research plan includes two follow-up visits, three and six months after the baseline visit. We anticipate that subjects will still be in the maintenance phase at the time of both these visits.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Bronx, New York, Estados Unidos, 10458
- Fordham University
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Bronx, New York, Estados Unidos, 10467
- Albert Einstein College of Medicine of Yeshiva University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 18 - 68
- English or Spanish speaking
- Documentation of HIV Status
- Opioid-dependent without having received medication treatment for opioid dependence within the previous 90 days
- Negative pregnancy test, for women
- No "street" use of methadone or buprenorphine
- Willing to participate in all study components
- Able to provide informed consent
- Education > 6 years
- Not acutely intoxicated
Exclusion Criteria:
- Serious or unstable medical disease: liver disease (AST or ALT ≥ 3x ULN, elevated PT/INR, albumin <3.0 g/dl or evidence of decompensated cirrhosis);
- Severe cardiovascular disease (MI, PTCA, unstable angina, CABG, and/or serious arrhythmia in the previous 6 months);
- COPD (requiring supplemental oxygen or hospitalization in past 6 months);
- End stage renal disease or creatinine clearance <30 mL/min
- Neurological disease: head injury with LOC>24 hour, previous penetrating skull wound, focal brain lesion, history of neurosurgery, seizure disorder (not ETOH-related), non-HIV CNS opportunistic infection
- Psychiatric disorders (schizophrenia or bipolar)
- Benzodiazepine or alcohol dependence
- Chronic pain conditions requiring opioid analgesics
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 |
---|---|
Experimental: Buprenorphine
Oral sublingual tablet, 8-32 mg per day, administered daily for duration of 4 months
|
Study participants will be randomly assigned 1:1 to buprenorphine (experimental/intervention) or methadone (active comparator).
We will stratify by HIV status to ensure an equal number of HIV-infected participants in each group.
Otros nombres:
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Comparador activo: Methadone
Oral sublingual tablet, 60-100 mg per day, administered daily for duration of 4 months
|
Study participants will be randomly assigned 1:1 to buprenorphine (experimental/intervention) or methadone (active comparator).
We will stratify by HIV status to ensure an equal number of HIV-infected participants in each group.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Global Neurocognitive Function
Periodo de tiempo: 2 and 4 months
|
Metrics: A Global Deficit Score (GDS) is computed by adding deficit ratings of the component test measures, and dividing by total number of measures. (Please see list of component test measures under the Domain-Specific Neurocognitive Function outcome). |
2 and 4 months
|
Domain-Specific Neurocognitive Function (i.e. in the domains of executive functioning, learning, memory, attention/working memory, processing speed, motor, and verbal functioning).
Periodo de tiempo: 2 and 4 months
|
Metrics: Domain Deficit Scores (DDS) are created for each of the 7 cognitive ability domains. Deficit Scores can be analyzed as dichotomous variables to classify individual subjects as impaired or normal, or continuously. Executive Functioning -- Wisconsin Card Sorting Task-64 Item Version; Trail Making Test (Part B) Learning -- Hopkins Verbal Learning Test-Revised (Total Recall); Brief Visuospatial Memory Test-Revised (Total Recall) Memory -- Hopkins Verbal Learning Test (Delayed Recall Trial); Brief Visuospatial Memory Test-Revised (Delayed Recall Trial) Attention/Working Memory -- WAIS-III Letter Number Sequencing; PASAT Total Correct Processing Speed -- WAIS-III Digit Symbol; WAIS-III Symbol Search; Trail Making Test (Part A) Motor -- Grooved Pegboard Time (dominant hand); Grooved Pegboard Time (non-dominant hand)] Verbal Functioning -- Controlled Oral Word Association Test (F-A-S); Semantic (Animal) Fluency |
2 and 4 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Julia Arnsten, MD, MPH, Montefiore Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Trastornos inducidos químicamente
- Trastornos relacionados con sustancias
- Trastornos relacionados con narcóticos
- Trastornos relacionados con opioides
- Efectos fisiológicos de las drogas
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Analgésicos
- Agentes del sistema sensorial
- Analgésicos Opiáceos
- Estupefacientes
- Antagonistas de narcóticos
- Agentes del sistema respiratorio
- Agentes antitusivos
- Buprenorfina
- Metadona
Otros números de identificación del estudio
- 2012-433
- 1R01DA032552-01A1 (Subvención/contrato del NIH de EE. UU.)
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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