ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating Safety and Efficacy of Cannabis in Participants With Chronic Posttraumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02517424
Recruitment Status : Recruiting
First Posted : August 7, 2015
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Tilray

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Drug: High THC/Low CBD Cannabis Drug: High THC/High CBD Cannabis Drug: Low THC/Low CBD Cannabis Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High THC/Low CBD Cannabis
Investigational product will be administered via vaporization up to 2 grams per day as needed.
Drug: High THC/Low CBD Cannabis
Dried cannabis

Experimental: High THC/High CBD cannabis
Investigational product will be administered via vaporization up to 2 grams per day as needed.
Drug: High THC/High CBD Cannabis
Dried cannabis

Placebo Comparator: Low THC/Low CBD cannabis
Product will be administered via vaporization up to 2 grams per day as needed.
Drug: Low THC/Low CBD Cannabis
Dried cannabis




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

Other Outcome Measures:
  1. Pulse rate following controlled self-administration of investigational product [ Time Frame: Day 0 ]
  2. Cannabis withdrawal symptoms [ Time Frame: For 2 weeks after administration period ]
  3. Change in problems associated with cannabis use based on Cannabis Use Disorders Identification Test [ Time Frame: 36 weeks ]
  4. Subjective drug effect via completion of the Drug Effect Questionnaire [ Time Frame: For 3 weeks in stage 1 and stage 2, respectively ]
  5. Presence of suicidal thoughts or behaviors via Columbia Suicide Severity Rating Scale [ Time Frame: 36 weeks ]
  6. Vital signs [ Time Frame: 0-10 weeks ]
  7. Dosing compliance via diary entry and product returns [ Time Frame: 0-10 weeks ]
  8. Abstinence compliance via urine cannabinoid levels [ Time Frame: -2 to 10 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet DSM-5 criteria for chronic PTSD of at least six months duration.
  2. Have PTSD of moderate severity as measured by a score of >= 40 on the PCL-5 at the time of baseline assessment.
  3. 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.
  4. Are at least 18 years old.
  5. Are willing to commit to medication dosing and delivery method, to completing evaluation instruments, and to attending all study visits.
  6. 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.
  7. Report no current hazardous cannabis use, as defined by a score of < 8 on the CUDIT-R at time of screening.
  8. Abstain from cannabis during the 2-week baseline assessment period as biochemically verified via urine cannabinoid concentrations.
  9. Agree to keep all study cannabis stored in a secure location and not to share/distribute cannabis to any other individual.
  10. Be stable on medications and/or psychotherapy for PTSD for at least one month prior to study entry.
  11. Agree to report any changes in medication or psychotherapy treatment regimen during the study to study staff.
  12. If female and of childbearing potential, agree to use an effective form of birth control during study participation.
  13. Participants must be proficient in reading English, and must be able to effectively communicate with the investigators and other site personnel.
  14. Agree not to participate in any other interventional clinical trials during study participation.
  15. Agree not to donate blood from the start of study treatment to 24 hours after the last dose.
  16. Agree to allow the collection of his/her gender, race, and occupation to ensure that the study recruits the targeted population.

Exclusion Criteria:

  1. Are pregnant or nursing, or of child bearing potential and not practicing an effective means of birth control.
  2. 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.
  3. Have any allergies to cannabis or contraindication for using cannabis.
  4. Are currently taking drugs known to be substrates for CYP 3A4 or CYP 2C19, such as amitriptyline, fentanyl, sufentanil, and alfentanil.
  5. 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.
  6. 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.
  7. Are not able to give adequate informed consent.
  8. Are not able to attend face-to-face visits or plan to move out of the area during the active treatment period.
  9. 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.
  10. 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.
  11. Have abnormal hepatic or renal function (abnormal liver function tests or elevated creatinine results on the screening laboratory reports).
  12. During the 2-week screening period, are diagnosed with dissociative identity disorder or an eating disorder with active purging, evidence of significant, uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, or neurological disease;
  13. During the 2-week screening period, meet criteria for cannabis use disorder (4 or more of 11 DSM-5 criteria) and continued cannabis use confirmed by urine testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517424


Contacts
Contact: Philippe Lucas, MA 250-722-3991 ext 9567 philippe@tilray.ca
Contact: Kaye Ong 250-755-6994 kaye.ong@tilray.ca

Locations
Canada, British Columbia
University of British Columbia Recruiting
Kelowna, British Columbia, Canada, V1V 1V7
Contact: Zachary Walsh, PhD       zachary.walsh@ubc.ca   
Contact: Ian Mitchell, MD         
Sponsors and Collaborators
Tilray
University of British Columbia

Responsible Party: Tilray
ClinicalTrials.gov Identifier: NCT02517424     History of Changes
Other Study ID Numbers: CMJP-1
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders