Study of the Safety and Efficacy of Nabiximols Oromucosal Spray Versus Placebo in Patients With Post-traumatic Stress Disorder

NCT04592159 | Withdrawn Phase 2

• 2 other identifiers: GWPD191772020-000527-39
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

Nabiximols; Selective serotonin reuptake inhibitor; Serotonin-norepinephrine reuptake inhibitor

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale (Clinician Administered PTSD Scale [CAPS-5]) Score over 8 Weeks

  Baseline; Week 8

Secondary Outcomes (9)

• Number of Participants Exhibiting Improvements Rated as Much or Very Much Improved on the Clinical Global Impressions Improvement (CGI-I) Scale at the End of Treatment (over 8 Weeks)

  from Baseline up to Week 8

• Change from Baseline in the Self-Reported PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Volume 5 (DSM-5) (PCL-5) Score over 8 Weeks

  Baseline; Week 8

• Number of Participants with any Treatment-Emergent Adverse Event

  up to Week 8

• Number of Participants with the Indicated Change from Baseline in Clinical Laboratory Test Values

  Baseline; Week 8

• Change from Baseline in Systolic Blood Pressure

  Baseline; Week 8

Study Arms (2)

Nabiximols

EXPERIMENTAL

Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides.Each spray delivers 100 microliters (μL) of nabiximols.

Drug: Nabiximols

Placebo

PLACEBO COMPARATOR

Placebo to match nabiximols will be presented as an oromucosal spray containing the excipients ethanol and propylene glycol (50% v/v) with colorings and flavored with peppermint oil (0.05% v/v). Each spray will deliver 100 μL containing no active ingredients. Placebo will be self-administered by participants as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 8 weeks.

Drug: Placebo

Interventions

Nabiximols DRUG

oromucosal spray

Also known as: GW-1000-02, Sativex

Nabiximols

Placebo DRUG

oromucosal spray

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 Δ9-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

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 19, 2020
• Study Start: February 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: June 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share