INTERVENTIONALWITHDRAWNNCT04592159

A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of Nabiximols Oromucosal Spray Versus Placebo in Patients With Post-traumatic Stress Disorder

This study will be conducted to evaluate the efficacy of nabiximols for the treatment of symptoms of post-traumatic stress disorder (PTSD) in participants receiving selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) pharmacotherapy.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2022-06-03

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2, PHASE3
Enrollment: 0 (ACTUAL)
Start date: 2021-02-01
Sponsor: Jazz Pharmaceuticals
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 0
Results record: Not present in registry snapshot

This multicenter, randomized, double-blind, placebo-controlled, parallel-group trial includes a screening period of up to 28 days, an 8-week treatment period (comprising a 2-week titration phase and a 6-week maintenance phase), and a 2-week follow-up period. At screening (Visit 1), all participants will receive instructions on how to complete a writing exercise (Exposure Writing Exercise) related to their traumatic experience. Prior to the baseline visit (Visit 2), participants must complete an approximate 30-minute writing exercise outside of the trial site and should have re-read the write up at least once to be eligible for enrollment. Throughout the screening and treatment periods, the dose of SSRI/SNRI used as background therapy, if any, should remain unchanged. On Day 1, eligible participants will be randomly assigned to either nabiximols or placebo in a 1:1 ratio. Participants will be advised to titrate the investigational medicinal product (IMP), beginning with 1 spray/day, to an optimized dose that relieves their most bothersome symptom of PTSD or to a maximum of 12 sprays/day over the first 14 days of treatment. Participants should continue at the same dose level achieved at the end of the titration phase ±1 spray divided into a morning dose and an evening dose for the remainder of the treatment period. Health-related quality of life, safety, and tolerability will be evaluated during the treatment period. Participants who complete the trial will participate for a total of approximately 14 weeks (99 days), including the 28-day Screening period.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Stress Disorders, Post-Traumatic

Cannabinoids and active compounds

No governed compound link was found.

Medicines

SATIVEX

Interventions

What was registered

DRUG

Nabiximols

oromucosal spray

GW-1000-02 · Sativex

DRUG

Placebo

oromucosal spray

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Not accepted

Inclusion criteria

Meets Diagnostic and Statistical Manual of Mental Disorders, Volume 5 (DSM-5) criteria for post-traumatic stress disorder (PTSD), confirmed on the basis of the Mini International Neuropsychiatric Interview (MINI)
If currently taking a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for the treatment of PTSD, SSRI/SNRI doses should be consistent with approved labelling and have been stable for at least 6 weeks prior to Visit 1 with no more than 1 SSRI/SNRI.
If not currently taking a SSRI or SNRI, should not have received treatment with either a SSRI or SNRI for at least 6 weeks prior to Visit 1 and is not planning to start additional pharmacotherapy during the study
Exhibits significant PTSD symptoms and associated impairment (as reflected by Clinician Administered PTSD Scale \[CAPS-5\] ≥ 27 and Clinical Global Impressions Severity \[CGI-S\] ≥ 4 at Visit 1), which should have persisted over a period of at least 3 months prior to Visit 1
Willing to allow the responsible authorities to be notified of participation in the trial, if mandated by local law
Willing to allow his or her primary care practitioner (if they have one) and consultant (if they have one) to be notified of participation in the trial, if the primary care practitioner/consultant is different to the investigator

Exclusion criteria

Is at risk of suicide as evidenced by a history of suicide attempt(s) in the 2 years prior to Visit 1 or answering yes on item 4 or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the month prior to Visit 1
Is currently involved in any legal action that relates to the diagnosis of PTSD or the traumatic events that gave rise to the disease
Has cognitive impairment that in the opinion of the investigator may interfere with participation in the study or ability to complete assessments or report treatment effects
Has any history of psychosis (including schizophrenia, schizophreniform disorder, schizoaffective disorder, or substance-induced psychosis), or bipolar disorder based on an assessment using the MINI.
Participants who have an index trauma before age 18 and no other traumatic experiences which could relate/identify as being part of their PTSD

primary outcomes