| Eligibility |
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
- Has taken cannabis or a cannabis derived product for medicinal or recreational
purposes at any time in the past and developed significant adverse experiences related
to cannabis use per history and investigator judgment
- Has severe depressive symptoms as per the investigator's judgment or a score = 20 on
the Patient Health Questionnaire-9 (PHQ-9) at Visit 1
- Has a history of any degree of DSM-5 cannabis or other substance use disorder, or
moderate to severe alcohol use disorder within 6 months prior to Visit 1. Participants
with Nicotine Use Disorder are allowed to enroll.
- Has any known or suspected hypersensitivity to cannabinoids or any of the excipients
of the investigational medicinal product
- Has recently taken nabiximols, cannabis, or a cannabis-derived product for medicinal
or recreational purposes as reflected by a positive ?9-tetrahydrocannabinol (THC)
urine test at Visit 1
- Currently taking 1 of a number of specified psychotropic medications, where there is a
potential for pharmacodynamic interactions. Participants taking any medication with
psychoactive properties not currently on the list of prohibitive medications may be
considered for enrollment only after consultation with a GW medical representative.
- Has experienced myocardial infarction or clinically significant cardiac dysfunction
within the 12 months prior to Visit 1 or has a cardiac disorder that, in the opinion
of the investigator, would put the participant at risk of a clinically significant
arrhythmia or myocardial infarction
- Positive serology panel (including hepatitis B surface antigen [HBsAg] and hepatitis C
virus [HCV] antibody)
- Positive human immunodeficiency virus (HIV) antibody/p24 antigen screens
- Has a diastolic blood pressure of < 50 millimeters of mercury (mmHg) or > 105 mmHg or
systolic blood pressure < 90 mmHg or > 150 mmHg (when measured in a sitting position
at rest for 5 minutes) or a postural drop in the systolic blood pressure of > 20 mmHg
at Visit 1
- Has clinically significant impaired renal function at Visit 1, as evidenced by an
estimated creatinine clearance lower than 50 milliliters per minute (mL/min)
- Has serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 ×
upper limit of normal (ULN) at Visit 1
- Male and fertile (i.e., after puberty unless permanently sterile by bilateral
orchiectomy) unless willing to ensure that he uses male contraception (condom or
vasectomy) or remains sexually abstinent during the trial and for 3 months thereafter
- Female and of childbearing potential (i.e., following menarche and until becoming
postmenopausal for = 12 consecutive months unless permanently sterile by hysterectomy,
bilateral salpingectomy, or bilateral oophorectomy) unless willing to ensure that she
uses a highly effective method of birth control (e.g., intrauterine
device/hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or
sexual abstinence) during the trial and for 3 months thereafter. Participants using
combined hormonal methods or a progestogen-only pill or injection or implant should
use an additional barrier method such as a male condom or diaphragm during the trial
and for 3 months thereafter.
- Female and pregnant (positive pregnancy test at Visit 1), lactating, or planning
pregnancy during the course of the trial or within 3 months thereafter
- Has participated in an interventional or non-interventional clinical trial within the
30 days prior to Visit 1
- Has donated blood during the 3 months prior to Visit 1 and is unwilling to abstain
from donation of blood during the trial
- Has been previously randomized into this trial
- Any abnormalities identified following a physical examination, clinical laboratory,
serology, or other applicable screen procedures that, in the opinion of the
investigator, would jeopardize the safety of the participant or the conduct of the
study if they took part in the trial
- Participants who are currently participating in a trauma-focused psychotherapy are
ineligible to participate in the trial. Participants who are participating in other
forms of psychotherapy (or none at all) must agree to continue (or not start) therapy
during the trial.
Additional exclusion criterion at Visit 2 (Day 1, pre-randomization):
- Exhibited a CAPS-5 score < 27 at Visit 2, or a reduction in CAPS-5 score of = 30% at
Visit 2 relative to Visit 1
- Did not complete the writing exercise during the screening period
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