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This pilot study gathered preliminary evidence of the safety and efficacy of four potencies of smoked cannabis to manage chronic, treatment-resistant PTSD among veterans: (1) High THC/ Low CBD (High THC), (2) Low THC/High CBD (High CBD), (3) High THC/ High CBD (THC/CBD) and (4) Low THC/Low CBD (placebo). The study will produce preliminary evidence to help elucidate the potential effects of THC, CBD, or a combination of both constituents to reduce PTSD symptoms. Smoked cannabis will be tested in two stages of three weeks each (Stage 1 and Stage 2), with a two-week cessation period after each stage, verified by blood/urine cannabinoid analysis. The primary objective was to compare three active concentrations of smoked cannabis and placebo on PTSD symptom severity measured by CAPS-5 total severity scores during Stage 1.
PTSD is a serious, worldwide public health problem resulting from traumatic experiences such as sexual assault, war, or abuse. PTSD is associated with high rates of psychiatric and medical co-morbidity, disability, suffering, and suicide. Despite available treatments for PTSD, many individuals continue to experience marked PTSD symptoms following treatment. In response to overwhelming demand for new treatments, several U.S. states have passed laws allowing the medical use of cannabis by individuals with PTSD.
Emerging observational and early clinical evidence suggest that cannabis may have the potential to reduce or ameliorate a number of symptoms experienced by those with PTSD, including sleep difficulty and anxiety. Indeed, some evidence has suggested that delta-9-tetrahydrocannabinol (THC) may serve to reduce nightmares among those with PTSD, while other studies have shown anxiolytic effects of cannabidiol (CBD). However, there have been no randomized controlled trials of cannabis, in any form, for PTSD.
The present triple-blind, randomized, placebo-controlled crossover trial aims to examine the safety and efficacy of four types of cannabis (i.e., high THC, low CBD; high CBD, low THC; equal ratio THC/CBD; and placebo) among 76 military veterans with chronic treatment-resistant PTSD of at least six months' duration. The study will produce preliminary evidence to help elucidate the contribution of THC, CBD, or a combination of both constituents to potential attenuation of PTSD symptoms.
Smoked cannabis was tested in two stages lasting three weeks each (Stage 1 and Stage 2), with a two-week cessation after each stage, verified by blood/urine cannabinoid analysis. The primary objective was to compare three active concentrations of smoked cannabis and placebo on PTSD symptom severity measured by CAPS-5 total scores during Stage 1.
Study participants received one of four different types of cannabis during Stage 1 with crossover and re-randomization, less the placebo cannabis, at Stage 2. The four potencies of cannabis were High THC/ Low CBD (High THC), Low THC/High CBD (High CBD), High THC/High CBD (THC/CBD) and Low THC/Low CBD (placebo). "High" is defined as marijuana containing a target of 7-15% concentration by weight of the respective cannabinoid and "Low" is defined as < 2% concentration by weight. Prior to each stage, participants completed two introductory sessions where they were trained on cannabis self-administration. During each stage, participants were provided 1.8 grams of cannabis daily to smoke ad libitum. Each stage was followed by a two-week cessation period.
The primary objective was to compare three active concentrations of smoked cannabis and placebo on PTSD symptom severity measured by CAPS-5 total severity scores during Stage 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High THC cannabis | Experimental | Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol |
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| High CBD cannabis | Experimental | Provided up to 1.8 g of cannabis per day of marijuana with more cannabidiol than tetrahydrocannabinol |
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| THC/CBD cannabis | Experimental | Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol |
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| Placebo cannabis | Placebo Comparator | Provided 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High THC cannabis | Drug | Three weeks of smoking cannabis containing more THC than CBD with amount smoked limited to no more than 1.8 g per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Baseline CAPS-5 Total Severity Score | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance), and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. | Baseline (3 weeks after randomization) |
| Stage 1 Primary Endpoint CAPS-5 Total Severity Scores (Visit 5) | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. | Visit 5 (between end of week 3 and start of week 4) of Stage 1 |
| Change in CAPS-5 Total Severity Scores From Baseline to Stage 1 Primary Endpoint (Visit 5) | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. | Baseline (3 weeks after randomization) to Primary Endpoint (Visit 5, between end of week 3 and start of week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTSD Checklist (PCL-5) From Baseline to Stage 1 Primary Endpoint | The PTSD Checklist (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms. Participants indicate how much distress they have experienced due to various PTSD symptoms on a five-point Likert-type scale (0=not at all, 4=extremely). The total PCL-5 score (a sum of all 20 items) ranges from 0 to 80, with higher scores indicating greater symptom severity. |
| Measure | Description | Time Frame |
|---|---|---|
| Actigraph Change in Sleep Efficiency | Daily sleep measures were collected using the Actigraph Watch at baseline and throughout the study period. Data were processed using the Actigraph Software according to the User Manual to measure "sleep efficiency," which is defined as the proportion of the estimated sleep periods spent asleep. Change in sleep efficiency was calculated and compared across the four treatment groups to assess whether there was any improvement or worsening in sleep efficiency before and after the 4-week treatment period. Other measures included number of days data were collected and average duration in minutes of time that were excluded and not recorded. Daily data were aggregated to analyze participants' average weekly sleep patterns. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue Sisley, MD | President of Scottsdale Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Research Institute | Phoenix | Arizona | 85027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33730032 | Result | Bonn-Miller MO, Sisley S, Riggs P, Yazar-Klosinski B, Wang JB, Loflin MJE, Shechet B, Hennigan C, Matthews R, Emerson A, Doblin R. The short-term impact of 3 smoked cannabis preparations versus placebo on PTSD symptoms: A randomized cross-over clinical trial. PLoS One. 2021 Mar 17;16(3):e0246990. doi: 10.1371/journal.pone.0246990. eCollection 2021. |
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For Stage 2, participants were re-randomized into one of three treatment groups which excluded placebo and their Stage 1 treatment assignment.
Participants were recruited via letters of referral sent to psychiatrists and psychotherapists, contact with veterans' organizations, advertisements or announcements placed in appropriate locations or on appropriate internet sites and the sponsor site, and word of mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | High THC Cannabis (Stage 1) | Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day. |
| FG001 | High CBD Cannabis (Stage 1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2016 | Aug 18, 2021 |
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| High CBD cannabis | Drug | Three weeks of smoking cannabis containing more CBD than THC with amount smoked limited to no more than 1.8 g per day. |
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| THC/CBD cannabis | Drug | Three weeks of smoking cannabis containing equal amounts of THC and CBD with smoking limited to no more than 1.8 g per day. |
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| Placebo cannabis | Drug | Three weeks of smoking cannabis with low levels of THC and CBD with smoking limited to no more than 1.8 per day. |
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| Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation) |
| Change in Inventory of Depression and Anxiety (IDAS) Social Anxiety Total Scores From Baseline to Stage 1 Primary Endpoint | The Inventory of Depression and Anxiety (IDAS) is a 64-item self-report measure of non-overlapping scales that assess specific depression and anxiety symptoms. Respondents indicate on a scale of 1 (not at all) to 5 (extremely) how much they have felt or experienced several symptoms in the past two weeks. The IDAS consists of 10 symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions. Items that assess social anxiety are summed and range from 5 to 25 with higher scores indicating greater anxiety symptoms. | Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation) |
| Change in Inventory of Psychosocial Functioning (IPF) From Baseline to Stage 1 Primary Endpoint | The Inventory of Psychosocial Functioning (IPF) is an 80-item measure that was developed for use among individuals with PTSD. It assesses current psychosocial functioning across seven domains: romantic relationships, family, work, friendships, parenting, education, and self-care. Items are scored on a 0 (never) to 6 (always) scale. Summation of scores across domains yields a total score for psychosocial functioning, with higher scores indicating greater functional impairment. | Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation) |
| Change in Inventory of Depression and Anxiety (IDAS) General Depression Total Scores From Baseline to Stage 1 Primary Endpoint | The Inventory of Depression and Anxiety (IDAS) is a 64-item self-report measure of non-overlapping scales that assess specific depression and anxiety symptoms. Respondents indicate on a scale of 1 (not at all) to 5 (extremely) how much they have felt or experienced several symptoms in the past two weeks. The IDAS consists of 10 symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions. Items that assess general depression are summed and range from 20 to 100 with higher scores indicating greater depressive symptoms. | Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation) |
| Change in Insomnia Severity Index (ISI) Scores From Baseline to Stage 1 Primary Endpoint | The Insomnia Severity Index (ISI) is a brief self-reported measure of insomnia. It consists of seven questions, with responses made on a five-point Likert scale. Three items address difficulty at sleep onset, maintaining sleep, and early waking, and four questions address perceived quality of sleep and effects of sleep difficulties on daily function. Questions are summed into a total score that ranges from 0 to 28 and can be interpreted as ranging from no signs of insomnia to severe insomnia. Higher scores indicate more severe insomnia. | Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation) |
| Change in sleep efficiency from baseline to end of 4-week treatment period (visit 6) |
Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day. |
| FG002 | THC/CBD Cannabis (Stage 1) | Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. |
| FG003 | Placebo Cannabis (Stage 1) | Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day. |
| FG004 | High THC Cannabis (Stage 2) | Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day. |
| FG005 | High CBD Cannabis (Stage 2) | Provided with up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day. |
| FG006 | THC/CBD Cannabis (Stage 2) | Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. |
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| Stage 2 |
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Intent-to-treat (ITT) set
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| ID | Title | Description |
|---|---|---|
| BG000 | High THC Cannabis | Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol High THC cannabis: Three weeks of smoking cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day. |
| BG001 | High CBD Cannabis | Provided up to 1.8 g of cannabis per day of marijuana with more cannabidiol than tetrahydrocannabinol High CBD cannabis: Three weeks of smoking cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day. |
| BG002 | High THC/ High CBD Cannabis | Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol High THC/high CBD cannabis: Three weeks of smoking cannabis containing equal amounts of THC and CBD, with smoking limited to no more than 1.8 g per day. |
| BG003 | Placebo Cannabis | Provided 1.8 g of cannabis per day a with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: Three weeks of smoking cannabis with low levels of THC and CBD, with smoking limited to no more than 1.8 per day. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Combat-related trauma (yes) | Count of Participants | Participants |
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| Sleep Apnea (STOP-bang) | Count of Participants | Participants |
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| Cannabis Use Disorders Identification Test-Revised (CUDIT-R) | The CUDIT-R is a brief cannabis screening tool to identify cannabis misuse. Participants who report past six month cannabis use are asked eight additional questions on cannabis where each item score range from 0 to 4. The total CUDIT-R score ranges from 0 to 24 with ≥ 8 indicating hazardous cannabis use and ≥ 12 indicating a possible cannabis use disorder. | Mean | Standard Deviation | score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Baseline CAPS-5 Total Severity Score | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance), and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 weeks after randomization) |
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| Primary | Stage 1 Primary Endpoint CAPS-5 Total Severity Scores (Visit 5) | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Visit 5 (between end of week 3 and start of week 4) of Stage 1 |
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| Primary | Change in CAPS-5 Total Severity Scores From Baseline to Stage 1 Primary Endpoint (Visit 5) | The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician administered and scored assessment of PTSD symptoms via structured interview based upon PTSD diagnosis in DSM-5. It contains symptom subscales, a CAPS-5 total severity score, and a diagnostic score. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance), and D (hypervigilance); and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 weeks after randomization) to Primary Endpoint (Visit 5, between end of week 3 and start of week 4) |
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| Secondary | Change in PTSD Checklist (PCL-5) From Baseline to Stage 1 Primary Endpoint | The PTSD Checklist (PCL-5) is a 20-item self-report questionnaire in which respondents indicate the presence and severity of PTSD symptoms. Participants indicate how much distress they have experienced due to various PTSD symptoms on a five-point Likert-type scale (0=not at all, 4=extremely). The total PCL-5 score (a sum of all 20 items) ranges from 0 to 80, with higher scores indicating greater symptom severity. | Intent-to-treat (ITT) Set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation) |
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| Secondary | Change in Inventory of Depression and Anxiety (IDAS) Social Anxiety Total Scores From Baseline to Stage 1 Primary Endpoint | The Inventory of Depression and Anxiety (IDAS) is a 64-item self-report measure of non-overlapping scales that assess specific depression and anxiety symptoms. Respondents indicate on a scale of 1 (not at all) to 5 (extremely) how much they have felt or experienced several symptoms in the past two weeks. The IDAS consists of 10 symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions. Items that assess social anxiety are summed and range from 5 to 25 with higher scores indicating greater anxiety symptoms. | Intent-to-treat (ITT) set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation) |
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| Secondary | Change in Inventory of Psychosocial Functioning (IPF) From Baseline to Stage 1 Primary Endpoint | The Inventory of Psychosocial Functioning (IPF) is an 80-item measure that was developed for use among individuals with PTSD. It assesses current psychosocial functioning across seven domains: romantic relationships, family, work, friendships, parenting, education, and self-care. Items are scored on a 0 (never) to 6 (always) scale. Summation of scores across domains yields a total score for psychosocial functioning, with higher scores indicating greater functional impairment. | Intent-to-treat (ITT) Set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation) |
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| Secondary | Change in Inventory of Depression and Anxiety (IDAS) General Depression Total Scores From Baseline to Stage 1 Primary Endpoint | The Inventory of Depression and Anxiety (IDAS) is a 64-item self-report measure of non-overlapping scales that assess specific depression and anxiety symptoms. Respondents indicate on a scale of 1 (not at all) to 5 (extremely) how much they have felt or experienced several symptoms in the past two weeks. The IDAS consists of 10 symptom scales: Suicidality, Lassitude, Insomnia, Appetite Loss, Appetite Gain, Ill Temper, Well-Being, Panic, Social Anxiety, and Traumatic Intrusions. Items that assess general depression are summed and range from 20 to 100 with higher scores indicating greater depressive symptoms. | Intent-to-treat (ITT) Set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation) |
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| Secondary | Change in Insomnia Severity Index (ISI) Scores From Baseline to Stage 1 Primary Endpoint | The Insomnia Severity Index (ISI) is a brief self-reported measure of insomnia. It consists of seven questions, with responses made on a five-point Likert scale. Three items address difficulty at sleep onset, maintaining sleep, and early waking, and four questions address perceived quality of sleep and effects of sleep difficulties on daily function. Questions are summed into a total score that ranges from 0 to 28 and can be interpreted as ranging from no signs of insomnia to severe insomnia. Higher scores indicate more severe insomnia. | Intent-to-treat Set | Posted | Mean | Standard Deviation | score on a scale | Baseline (3 weeks after randomization) to Stage 1 Primary Endpoint (Visit 6, 3 weeks post self-administration and prior to cessation) |
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| Other Pre-specified | Actigraph Change in Sleep Efficiency | Daily sleep measures were collected using the Actigraph Watch at baseline and throughout the study period. Data were processed using the Actigraph Software according to the User Manual to measure "sleep efficiency," which is defined as the proportion of the estimated sleep periods spent asleep. Change in sleep efficiency was calculated and compared across the four treatment groups to assess whether there was any improvement or worsening in sleep efficiency before and after the 4-week treatment period. Other measures included number of days data were collected and average duration in minutes of time that were excluded and not recorded. Daily data were aggregated to analyze participants' average weekly sleep patterns. | All participants were asked to wear the Actiwatch for sleep measures and all available data were analyzed to assess sleep efficiency. Note: the proportion of missing data prevented robust analysis and interpretation. | Posted | Mean | Standard Deviation | percentage of total sleep time | Change in sleep efficiency from baseline to end of 4-week treatment period (visit 6) |
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Baseline to end of study (Approximately 8 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High THC Cannabis (Stage 1) | Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day. | 0 | 20 | 0 | 20 | 17 | 20 |
| EG001 | High CBD Cannabis (Stage 1) | Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day. | 0 | 20 | 0 | 20 | 19 | 20 |
| EG002 | THC/CBD Cannabis (Stage 1) | Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. | 0 | 20 | 3 | 20 | 19 | 20 |
| EG003 | Placebo Cannabis (Stage 1) | Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day. | 0 | 20 | 0 | 20 | 18 | 20 |
| EG004 | High THC Cannabis (Stage 2) | Provided up to 1.8 g of cannabis per day with more tetrahydrocannabinol than cannabidiol High THC cannabis: three weeks of smoked cannabis containing more THC than CBD, with amount smoked limited to no more than 1.8 g per day. | 0 | 29 | 1 | 29 | 22 | 29 |
| EG005 | High CBD Cannabis (Stage 2) | Provided up to 1.8 g of cannabis per day with more cannabidiol than tetrahydrocannabinol High CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day. | 0 | 27 | 1 | 27 | 22 | 27 |
| EG006 | THC/CBD Cannabis (Stage 2) | Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing more CBD than THC, with amount smoked limited to no more than 1.8 g per day. | 0 | 18 | 0 | 18 | 13 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart palpitations | Cardiac disorders | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Abscess | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Asthenia | General disorders | Non-systematic Assessment |
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| Chest discomfort | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Feeling abnormal | General disorders | Non-systematic Assessment |
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| Malaise | General disorders | Non-systematic Assessment |
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| Cellulitis | General disorders | Non-systematic Assessment |
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| Ear infection | Infections and infestations | Non-systematic Assessment |
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| Influenza | General disorders | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Weight decreased | Investigations | Non-systematic Assessment |
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| Weight increased | Investigations | Non-systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Muscle tightness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Torticollis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Balance disorder | Nervous system disorders | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Head discomfort | Nervous system disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Memory impairment | Nervous system disorders | Non-systematic Assessment |
| ||
| Sensory disturbance | Nervous system disorders | Non-systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| Tremor | Nervous system disorders | Non-systematic Assessment |
| ||
| Aggression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Emotional distress | Psychiatric disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Irritability | Psychiatric disorders | Non-systematic Assessment |
| ||
| Libido increased | Psychiatric disorders | Non-systematic Assessment |
| ||
| Nightmare | Psychiatric disorders | Non-systematic Assessment |
| ||
| Panic attack | Psychiatric disorders | Non-systematic Assessment |
| ||
| Paranoia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Restlessness | Psychiatric disorders | Non-systematic Assessment |
| ||
| Pollakiuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urine abnormality | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Skin irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Surgery | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Tooth repair | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Food poisoning | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Discomfort | General disorders | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Heat exhaustion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Lethargy | Nervous system disorders | Non-systematic Assessment |
| ||
| Migraine | Nervous system disorders | Non-systematic Assessment |
| ||
| Parosmia | Nervous system disorders | Non-systematic Assessment |
| ||
| Anger | Psychiatric disorders | Non-systematic Assessment |
| ||
| Confusional state | Psychiatric disorders | Non-systematic Assessment |
| ||
| Hostility | Psychiatric disorders | Non-systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Wisdom teeth removal | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
| ||
| Bacterial infection | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Streptococcal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Joint dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bacterial vaginosis | Infections and infestations | Non-systematic Assessment |
| ||
| Fungal infections | Infections and infestations | Non-systematic Assessment |
| ||
| Obsessive thoughts | Psychiatric disorders | Non-systematic Assessment |
| ||
| Suicide ideation | Psychiatric disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Berra Yazar-Klosinski, PhD / Chief Scientific Officer | Multidisciplinary Association for Psychedelic Studies (MAPS) Public Benefit Corporation | (831) 429-6362 | trialdata@mapsbcorp.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 31, 2016 | Jun 7, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2017 | Jun 14, 2022 | ICF_002.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Withdrawal by Subject |
|
| Male |
|
| Other |
|
| Some College/Associate's Degree |
|
| College Graduate |
|
| Intermediate risk = 2 |
|
| High risk = 3 |
|
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol High THC/high CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. |
| OG003 | Placebo Cannabis | Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day. |
|
|
| THC/CBD Cannabis |
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. |
| OG003 | Placebo Cannabis | Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day. |
|
|
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. |
| OG003 | Placebo Cannabis | Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day. |
|
|
| OG002 | THC/CBD Cannabis | Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. |
| OG003 | Placebo Cannabis | Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day. |
|
|
| THC/CBD Cannabis |
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. |
| OG003 | Placebo Cannabis | Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: three weeks of smoking cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day. |
|
|
| OG002 | THC/CBD Cannabis | Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. |
| OG003 | Placebo Cannabis | Provided with 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day. |
|
|
| OG002 |
| THC/CBD Cannabis |
Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: three weeks of smoked cannabis containing approximate equal amounts of THC and CBD, with amount smoked limited to no more than 1.8 g per day. |
| OG003 | Placebo Cannabis | Provided up to 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: three weeks of smoked cannabis with low levels of THC and CBD, with amount smoked limited to no more than 1.8 per day. |
|
|
| OG002 | THC/CBD Cannabis | Provided up to 1.8 g of cannabis per day with an approximately equal amount of tetrahydrocannabinol and cannabidiol THC/CBD cannabis: Three weeks of smoking cannabis containing equal amounts of THC and CBD with smoking limited to no more than 1.8 g per day. |
| OG003 | Placebo Cannabis | Provided 1.8 g of cannabis per day with very low levels of tetrahydrocannabinol and cannabidiol Placebo cannabis: Three weeks of smoking cannabis with low levels of THC and CBD with smoking limited to no more than 1.8 per day. |
|
|