Posttraumatic Stress DisorderPhase 2NCT02517424
Evaluating Safety and Efficacy of Cannabis in Participants With Chronic Posttraumatic Stress Disorder
A Phase 2 study testing High THC/Low CBD Cannabis, High THC/High CBD Cannabis and Low THC/Low CBD Cannabis in people with Posttraumatic Stress Disorder, run by Tilray at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- High THC/Low CBD Cannabis, High THC/High CBD Cannabis and Low THC/Low CBD Cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 7 Feb 2017to 22 Mar 2019
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Agree to report any changes in medication or psychotherapy treatment regimen during the study to study staff.
- If female and of childbearing potential, agree to use an effective form of birth control during study participation.
- Participants must be proficient in reading English, and must be able to effectively communicate with the investigators and other site personnel.
- Agree not to participate in any other interventional clinical trials during study participation.
- Agree not to donate blood from the start of study treatment to 24 hours after the last dose.
- Agree to allow the collection of his/her gender, race, and occupation to ensure that the study recruits the targeted population.
Who cannot join
- 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.
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- 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.
- Have abnormal hepatic or renal function (abnormal liver function tests or elevated creatinine results on the screening laboratory reports).
- During the 8-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;
- During the 8-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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
The purpose of this study is to evaluate the safety and efficacy of vaporized cannabis in participants with chronic, treatment-resistant posttraumatic stress disorder.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- High THC/Low CBD Cannabis, High THC/High CBD Cannabis, Low THC/Low CBD Cannabis
- Keywords
- PTSD
- 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.
High THC/Low CBD CannabisDrug
Dried cannabis
High THC/High CBD CannabisDrug
Dried cannabis
Low THC/Low CBD CannabisDrug
Dried cannabis
| Study group | Role | What they receive |
|---|---|---|
| High THC/Low CBD Cannabis | Experimental | Investigational product will be administered via vaporization up to 2 grams per day as needed. Receives: Drug: High THC/Low CBD Cannabis |
| High THC/High CBD cannabis | Experimental | Investigational product will be administered via vaporization up to 2 grams per day as needed. Receives: Drug: High THC/High CBD Cannabis |
| Low THC/Low CBD cannabis | Placebo comparator | Product will be administered via vaporization up to 2 grams per day as needed. Receives: Drug: Low THC/Low CBD Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 weeks
Secondary outcomes (12)
Change in PTSD symptoms during Stage 1 using PTSD Checklist 5 (PCL 5).
Measured: 3 weeks
Change in PTSD symptoms during Stage 2 using PCL 5 checklist.
Measured: 3 weeks
Change in symptoms of anxiety in Stage 1 via the Inventory of Depression and Anxiety Scale
Measured: 3 weeks
Change in symptoms of anxiety in Stage 2 via the Inventory of Depression and Anxiety Scale
Measured: 3 weeks
Change in symptoms of depression in Stage 2 via the Inventory of Depression and Anxiety Scale
Measured: 3 weeks
Change in psychosocial functioning in Stage 2 via the Inventory of Psychosocial Functioning
Measured: 3 weeks
Preference for Stage 1 vs Stage 2 cannabis using the Long-term Follow-up Questionnaire
Measured: 34 weeks
Change in PTSD symptoms via CAPS assessment over Stage 1 and 2.
Measured: 8 weeks
Change in PTSD symptoms via PCL-5 assessment during abstinence periods.
Measured: 2 weeks
Change in sleep quality via actigraphy measures
Measured: 10 weeks
Change in sleep quality via Insomnia Severity Index
Measured: 8 weeks
Change in sleep quality via Sleep Diary entries
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study start7 Feb 2017
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilray
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Zach Walsh, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517424
- Sponsor's protocol ID
- CMJP-1
- Status last verified
- Mar 2020
- First submitted
- 31 Jul 2015
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02517424
- Acronym / sponsor ID
- CMJP-1
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- TilrayIndustry (pharma, biotech, devices)
- Collaborators
- University of British Columbia
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of vaporized cannabis in participants with chronic, treatment-resistant posttraumatic stress disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High THC/Low CBD Cannabis | Experimental | Drug: High THC/Low CBD CannabisInvestigational product will be administered via vaporization up to 2 grams per day as needed. |
| High THC/High CBD cannabis | Experimental | Drug: High THC/High CBD CannabisInvestigational product will be administered via vaporization up to 2 grams per day as needed. |
| Low THC/Low CBD cannabis | Placebo comparator | Drug: Low THC/Low CBD CannabisProduct will be administered via vaporization up to 2 grams per day as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High THC/Low CBD CannabisDried cannabis | Drug | High THC/Low CBD Cannabis |
| High THC/High CBD CannabisDried cannabis | Drug | High THC/High CBD cannabis |
| Low THC/Low CBD CannabisDried cannabis | Drug | Low THC/Low CBD cannabis |
Primary outcome
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
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zach Walsh, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High THC/Low CBD Cannabis, High THC/High CBD Cannabis and Low THC/Low CBD Cannabis in people with Posttraumatic Stress Disorder, run by Tilray at 1 site in Canada.
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 16 inclusion and 13 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: finished, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.