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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02517424
Recruitment Status : Suspended (Site 1 has completed recruitment. Activation of site 2 is still in progress.)
First Posted : August 7, 2015
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Tilray

Tracking Information
First Submitted Date  ICMJE July 31, 2015
First Posted Date  ICMJE August 7, 2015
Last Update Posted Date September 12, 2019
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2015)
Change from baseline to end of Stage 1 in posttraumatic stress disorder symptoms via Clinician Administered PTSD Scale for DSM-5. [ Time Frame: 3 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2016)
  • Change in PTSD symptoms during Stage 1 using PTSD Checklist 5 (PCL 5). [ Time Frame: 3 weeks ]
  • Change in PTSD symptoms during Stage 2 using PCL 5 checklist. [ Time Frame: 3 weeks ]
  • Change in symptoms of anxiety in Stage 1 via the Inventory of Depression and Anxiety Scale [ Time Frame: 3 weeks ]
  • Change in symptoms of anxiety in Stage 2 via the Inventory of Depression and Anxiety Scale [ Time Frame: 3 weeks ]
  • Change in symptoms of depression in Stage 2 via the Inventory of Depression and Anxiety Scale [ Time Frame: 3 weeks ]
  • Change in psychosocial functioning in Stage 2 via the Inventory of Psychosocial Functioning [ Time Frame: 3 weeks ]
  • Preference for Stage 1 vs Stage 2 cannabis using the Long-term Follow-up Questionnaire [ Time Frame: 34 weeks ]
  • Change in PTSD symptoms via CAPS assessment over Stage 1 and 2. [ Time Frame: 8 weeks ]
  • Change in PTSD symptoms via PCL-5 assessment during abstinence periods. [ Time Frame: 2 weeks ]
  • Change in sleep quality via actigraphy measures [ Time Frame: 10 weeks ]
  • Change in sleep quality via Insomnia Severity Index [ Time Frame: 8 weeks ]
  • Change in sleep quality via Sleep Diary entries [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2015)
  • Change from Stage 2 baseline to end of Stage 2 in PTSD symptoms via PTSD Checklist (PCL-5) [ Time Frame: 3 weeks ]
  • Change in PTSD symptoms from baseline to end of stage 2 in participants who were randomized to placebo in Stage 1 via CAPS-5 scores. [ Time Frame: 8 weeks ]
  • Change in PTSD symptoms during 2 week cannabis abstinence periods between Stage 1 and Stage 2 compared with CAPS-5 measures assessed at Baseline and during Stage 1. [ Time Frame: 2 weeks ]
  • Change in sleep quality from baseline to end of Stage 2 via the Pittsburgh Sleep Quality Index. [ Time Frame: 8 weeks ]
  • Change from Stage 2 baseline to end of Stage 2 in depression and anxiety via the Inventory of Depresssion and Anxiety (IDAS) [ Time Frame: 3 weeks ]
  • Change from Stage 2 baseline to end of Stage 2 in psychosocial functioning via the Inventory of Psychosocial Functioning (IPF). [ Time Frame: 3 weeks ]
  • Change in sleep quality from baseline to end of Stage 2 via Actigraphy measures. [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: November 23, 2016)
  • Pulse rate following controlled self-administration of investigational product [ Time Frame: Day 0 ]
  • Cannabis withdrawal symptoms [ Time Frame: For 2 weeks after administration period ]
  • Change in problems associated with cannabis use based on Cannabis Use Disorders Identification Test [ Time Frame: 36 weeks ]
  • Subjective drug effect via completion of the Drug Effect Questionnaire [ Time Frame: For 3 weeks in stage 1 and stage 2, respectively ]
  • Presence of suicidal thoughts or behaviors via Columbia Suicide Severity Rating Scale [ Time Frame: 36 weeks ]
  • Vital signs [ Time Frame: 0-10 weeks ]
  • Dosing compliance via diary entry and product returns [ Time Frame: 0-10 weeks ]
  • Abstinence compliance via urine cannabinoid levels [ Time Frame: -2 to 10 weeks ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating Safety and Efficacy of Cannabis in Participants With Chronic Posttraumatic Stress Disorder
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Posttraumatic Stress Disorder
Intervention  ICMJE
  • Drug: High THC/Low CBD Cannabis
    Dried cannabis
  • Drug: High THC/High CBD Cannabis
    Dried cannabis
  • Drug: Low THC/Low CBD Cannabis
    Dried cannabis
Study Arms  ICMJE
  • Experimental: High THC/Low CBD Cannabis
    Investigational product will be administered via vaporization up to 2 grams per day as needed.
    Intervention: Drug: High THC/Low CBD Cannabis
  • Experimental: High THC/High CBD cannabis
    Investigational product will be administered via vaporization up to 2 grams per day as needed.
    Intervention: Drug: High THC/High CBD Cannabis
  • Placebo Comparator: Low THC/Low CBD cannabis
    Product will be administered via vaporization up to 2 grams per day as needed.
    Intervention: Drug: Low THC/Low CBD Cannabis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: November 9, 2015)
42
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2015)
40
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02517424
Other Study ID Numbers  ICMJE CMJP-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tilray
Study Sponsor  ICMJE Tilray
Collaborators  ICMJE University of British Columbia
Investigators  ICMJE Not Provided
PRS Account Tilray
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP