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| Name | Class |
|---|---|
| University of British Columbia | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of vaporized cannabis in participants with chronic, treatment-resistant posttraumatic stress disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High THC/Low CBD Cannabis | Experimental | Investigational product will be administered via vaporization up to 2 grams per day as needed. |
|
| High THC/High CBD cannabis | Experimental | Investigational product will be administered via vaporization up to 2 grams per day as needed. |
|
| Low THC/Low CBD cannabis | Placebo Comparator | Product will be administered via vaporization up to 2 grams per day as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High THC/Low CBD Cannabis | Drug | Dried cannabis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD symptoms during Stage 1 using PTSD Checklist 5 (PCL 5). | 3 weeks | |
| Change in PTSD symptoms during Stage 2 using PCL 5 checklist. | 3 weeks | |
| Change in symptoms of anxiety in Stage 1 via the Inventory of Depression and Anxiety Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse rate following controlled self-administration of investigational product | Day 0 | |
| Cannabis withdrawal symptoms | For 2 weeks after administration period | |
| Change in problems associated with cannabis use based on Cannabis Use Disorders Identification Test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zach Walsh, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Kelowna | British Columbia | V1V 1V7 | Canada |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| High THC/High CBD Cannabis |
| Drug |
Dried cannabis |
|
| Low THC/Low CBD Cannabis | Drug | Dried cannabis |
|
| 3 weeks |
| Change in symptoms of anxiety in Stage 2 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 psychosocial functioning in Stage 2 via the Inventory of Psychosocial Functioning | 3 weeks |
| Preference for Stage 1 vs Stage 2 cannabis using the Long-term Follow-up Questionnaire | 34 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 |
| Change in sleep quality via actigraphy measures | 10 weeks |
| Change in sleep quality via Insomnia Severity Index | 8 weeks |
| Change in sleep quality via Sleep Diary entries | 8 weeks |
| 36 weeks |
| Subjective drug effect via completion of the Drug Effect Questionnaire | For 3 weeks in stage 1 and stage 2, respectively |
| Presence of suicidal thoughts or behaviors via Columbia Suicide Severity Rating Scale | 36 weeks |
| Vital signs | 0-10 weeks |
| Dosing compliance via diary entry and product returns | 0-10 weeks |
| Abstinence compliance via urine cannabinoid levels | -2 to 10 weeks |