Nabilone in Cannabis Users With PTSD

Solo los usuarios registrados pueden traducir artículos

Iniciar sesión Registrarse

El enlace se guarda en el portapapeles.

EstadoTerminado

Patrocinadores

New York State Psychiatric Institute

Colaboradores

National Institute on Drug Abuse (NIDA)

ENSAYO CLÍNICO: NCT03251326

BioSeek: nct03251326

Palabras clave

Abstracto

Despite the prevalence of cannabis use among the PTSD population and self-reports that it is used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are unknown. The purpose of this placebo-controlled, within-subject study is to assess the effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in cannabis smokers with PTSD.

Descripción

This study will compare the effects of smoked cannabis and nabilone on attentional bias toward trauma- related stimuli, subjective and emotional processing to a range of trauma-and non-trauma-related images and physiological reactivity to these stimuli in individuals with CUD and PTSD. Importantly, this study will also probe the abuse related potential of nabilone compared to smoked cannabis in this population, a critical aspect in determining the potential feasibility for its use clinically to treat CUD in PTSD populations. The effects of nabilone will be compared to propranolol as a positive control.

fechas

Verificado por última vez:	10/31/2019
Primero enviado:	08/13/2017
Inscripción estimada enviada:	08/13/2017
Publicado por primera vez:	08/15/2017
Última actualización enviada:	11/05/2019
Última actualización publicada:	11/07/2019
Fecha de inicio real del estudio:	09/30/2015
Fecha estimada de finalización primaria:	05/31/2019
Fecha estimada de finalización del estudio:	05/31/2019

Condición o enfermedad

Cannabis

Post Traumatic Stress Disorder

Intervención / tratamiento

Drug: Nabilone

Drug: Smoked cannabis

Drug: Propranolol

Drug: Placebo

Fase

Fase 1/Fase 2

Grupos de brazos

Brazo	Intervención / tratamiento
Experimental: Nabilone Nabilone capsules (4 mg)	Drug: Nabilone Nabilone capsules (4 mg)
Active Comparator: Propranolol Propranolol capsules (40mg)	Drug: Propranolol Propranolol capsules (40mg)
Experimental: Smoked cannabis (0.0 and 5.6% THC)	Drug: Smoked cannabis Cigarettes (0.0 and 5.6% THC)
Placebo Comparator: Placebo Placebo capsules	Drug: Placebo Placebo capsules

Criterio de elegibilidad

Edades elegibles para estudiar	21 Years A 21 Years
Sexos elegibles para estudiar	All
Acepta voluntarios saludables	si
Criterios	Inclusion Criteria: - Current cannabis use - PTSD symptoms - Able to give informed consent and comply with study procedures - Women who are normally cycling and practicing an effective form of birth control other than hormonal contraceptives Exclusion Criteria: - Meeting criteria for certain current psychiatric disorders - Clinical laboratory tests outside of normal limits - History of clinically significant cardiac or respiratory diagnoses - Current parole or probation - Women who are currently pregnant or breastfeeding

Salir

Medidas de resultado primarias

1. Cue Reactivity [1 month]

Emotional Stroop Task