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Post-Traumatic Stress DisorderPhase 2/3NCT04592159

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

A Phase 2/3 study testing Nabiximols in people with Post-Traumatic Stress Disorder, run by Jazz Pharmaceuticals.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Post-Traumatic Stress Disorder
What is being tested?
Nabiximols
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Feb 2021to Mar 2023
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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
  • 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

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Nabiximols, Placebo
Keywords
Nabiximols, Selective serotonin reuptake inhibitor, Serotonin-norepinephrine reuptake inhibitor
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NabiximolsDrug

    Also called GW-1000-02, Sativex

    oromucosal spray

  • PlaceboDrug

    oromucosal spray

Study groups in NCT04592159
Study groupRoleWhat they receive
NabiximolsExperimentalNabiximols 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.
Receives: Drug: Nabiximols
PlaceboPlacebo comparatorPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline; Week 8

Secondary outcomes (9)

  1. 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)

    Measured: from Baseline up to Week 8

  2. 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

    Measured: Baseline; Week 8

  3. Number of Participants with any Treatment-Emergent Adverse Event

    Measured: up to Week 8

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

    Measured: Baseline; Week 8

  5. Change from Baseline in Systolic Blood Pressure

    Measured: Baseline; Week 8

  6. Change from Baseline in Diastolic Blood Pressure

    Measured: Baseline; Week 8

  7. Change from Baseline in Pulse Rate

    Measured: Baseline; Week 8

  8. Number of Participants with Clinically Significant 12-Lead Electrocardiogram (ECG) Parameter Values

    Measured: from Baseline up to 8 weeks

  9. Change from Baseline in the Columbia-Suicide Severity Rating Scale (C-SSRS) Score

    Measured: Baseline; Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2020
  2. Study start1 Feb 2021 (estimated)
  3. Primary completionMar 2023 (estimated)
  4. Study completionMar 2023 (estimated)

Why it stopped: The decision to suspend this study was based upon evaluation of pandemic-related challenges impacting both clinical trial sites and potential participants. This suspension was initiated prior to site activation and participant recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04592159
Sponsor's protocol ID
GWPD19177
Other IDs
2020-000527-39
Status last verified
Jun 2022
First submitted
7 Oct 2020
Last updated
3 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nabiximols in people with Post-Traumatic Stress Disorder, run by Jazz Pharmaceuticals.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale (Clinician Administered PTSD Scale [CAPS-5]) Score over 8 Weeks (time frame: Baseline; Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04592159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.

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