Placebo-Controlled, Triple-Blind, Crossover Study of the Safety and Efficacy of Three Different Potencies of Vaporized Cannabis in 42 Participants With Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

Tilray1 site in 1 country6 target enrollmentFebruary 7, 2017

ConditionsPosttraumatic Stress Disorder

InterventionsHigh THC/Low CBD Cannabis High THC/High CBD Cannabis Low THC/Low CBD Cannabis

DrugsHigh THC/Low CBD Cannabis High THC/High CBD Cannabis Low THC/Low CBD Cannabis

Overview

Phase: Phase 2
Intervention: High THC/Low CBD Cannabis
Conditions: Posttraumatic Stress Disorder
Sponsor: Tilray
Enrollment: 6
Locations: 1
Primary Endpoint: Change from baseline to end of Stage 1 in posttraumatic stress disorder symptoms via Clinician Administered PTSD Scale (CAPS) for Diagnostic and Statistical Manual of Mental Disorders (DSM)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of vaporized cannabis in participants with chronic, treatment-resistant posttraumatic stress disorder.

Registry

clinicaltrials.gov

Start Date

February 7, 2017

End Date

March 22, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Tilray

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Meet DSM-5 criteria for chronic PTSD of at least six months duration.
•Have PTSD of moderate severity as measured by a score of \>= 40 on the PCL-5 at the time of baseline assessment.
•Have treatment resistant PTSD defined as meeting DSM-5 diagnostic criteria for PTSD after failing on, or being unable to tolerate, Health Canada-approved medication or empirically supported psychotherapy for PTSD of adequate dose and duration, as determined on a case-by-case basis by the site investigators.
•Are at least 18 years old.
•Are willing to commit to medication dosing and delivery method, to completing evaluation instruments, and to attending all study visits.
•Agree to use only cannabis provided by study staff until the end of Stage 2 and agree to required cessation periods for the duration of the study.
•Report no current hazardous cannabis use, as defined by a score of \< 11 on the CUDIT-R at time of screening.
•Abstain from cannabis during the 8-week baseline assessment period as biochemically verified via urine cannabinoid concentrations.
•Agree to keep all study cannabis stored in a secure location and not to share/distribute cannabis to any other individual.
•Be stable on medications and/or psychotherapy for PTSD for at least one month prior to study entry.

Exclusion Criteria

•Are pregnant or nursing, or of child bearing potential and not practicing an effective means of birth control.
•Have a history of primary psychotic disorder, bipolar affective disorder, bipolar disorder with psychotic features, depressive disorder with psychotic features, borderline personality disorder, antisocial personality disorder, or positive family history (first degree relative) of psychotic disorder or bipolar affective disorder.
•Have any allergies to cannabis or contraindication for using cannabis.
•Are currently taking drugs known to be substrates for CYP 3A4 or CYP 2C19, such as amitriptyline, fentanyl, sufentanil, and alfentanil.
•Have a diagnosis of obstructive sleep apnea or a score of \>3 on the STOP-Bang questionnaire (except in cases where the participant has documented evidence of not having obstructive sleep apnea OR if the participant is compliant on CPAP treatment). Documented evidence consists of a negative result for obstructive sleep apnea on the completion of a formal assessment for apnea.
•Would present a serious suicide risk as assessed by the investigators, or who are likely to require psychiatric hospitalization during the course of the study.
•Are not able to give adequate informed consent.
•Are not able to attend face-to-face visits or plan to move out of the area during the active treatment period.
•Have a positive urine drug screen for opiates (unless prescribed or contained in an over-the-counter Health Canada approved medication), methamphetamine, cocaine and amphetamines or meet the DSM-5 criteria for substance use disorder (other than caffeine or nicotine) during Stage 1 and 2 of the study.
•Have signs of ischemia (defined as ST elevation or depression) or significant arrhythmia (defined as atrial fibrillation or flutter, ventricular fibrillation or flutter) on the screening electrocardiogram.

Arms & Interventions

High THC/Low CBD Cannabis

Investigational product will be administered via vaporization up to 2 grams per day as needed.

Intervention: High THC/Low CBD Cannabis

High THC/High CBD cannabis

Investigational product will be administered via vaporization up to 2 grams per day as needed.

Intervention: High THC/High CBD Cannabis

Low THC/Low CBD cannabis

Product will be administered via vaporization up to 2 grams per day as needed.

Intervention: Low THC/Low CBD Cannabis

Outcomes

Primary Outcomes

Change from baseline to end of Stage 1 in posttraumatic stress disorder symptoms via Clinician Administered PTSD Scale (CAPS) for Diagnostic and Statistical Manual of Mental Disorders (DSM)

Time Frame: 3 weeks

Secondary Outcomes

Change in psychosocial functioning in Stage 2 via the Inventory of Psychosocial Functioning(3 weeks)
Change in PTSD symptoms during Stage 1 using PTSD Checklist 5 (PCL 5).(3 weeks)
Change in sleep quality via Sleep Diary entries(8 weeks)
Change in symptoms of anxiety in Stage 1 via the Inventory of Depression and Anxiety Scale(3 weeks)
Change in symptoms of depression in Stage 2 via the Inventory of Depression and Anxiety Scale(3 weeks)
Change in symptoms of anxiety in Stage 2 via the Inventory of Depression and Anxiety Scale(3 weeks)
Change in sleep quality via actigraphy measures(10 weeks)
Change in sleep quality via Insomnia Severity Index(8 weeks)
Change in PTSD symptoms during Stage 2 using PCL 5 checklist.(3 weeks)
Change in PTSD symptoms via CAPS assessment over Stage 1 and 2.(8 weeks)
Change in PTSD symptoms via PCL-5 assessment during abstinence periods.(2 weeks)
Preference for Stage 1 vs Stage 2 cannabis using the Long-term Follow-up Questionnaire(34 weeks)