Primary Outcomes

Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).

Measure: Prevention of COVID-19

Time: Five years

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Description: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).

Measure: Treatment of COVID-19

Time: Five years

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Description: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.

Measure: Treatment of Symptoms

Time: Five years

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Secondary Outcomes

Description: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.

Measure: Cannabis Impact on Quality of Life

Time: Five years

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Description: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.

Measure: Cannabis Route and Dosing

Time: Five years

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Description: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.

Measure: Monitoring Adverse Events

Time: Five years

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Primary Outcomes

Description: Less than or equal to 10 This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Secondary Outcomes

Description: changes in scores This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Change in Hamilton Rating Scale for Depresion 24-it (HRSD-24)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: 50% Reduction in score This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Response on Hamilton Rating Scale for Depresion 24-it (HRSD-24)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: changes in scores This scale is used to quantify the severity of symptoms of mania Scale range: 0-60 (total score) Lower scores indicate lower severity of manic symptoms (i.e., better outcome) Higher scores indicate higher severity of manic symptoms (i.e., worse outcome)

Measure: Change in Young Mania Rating Scale (YMRS)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: Less than or equal to 4 This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Remission on Patient Health Questionnaire (PHQ-9)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: 50% Reduction in score This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Response on Patient Health Questionnaire (PHQ-9)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: changes in scores This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Change in Patient Health Questionnaire (PHQ-9)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: Less than or equal to 4 This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)

Measure: Remission on General Anxiety Disorder 7 item (GAD-7)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: 50% Reduction in score This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)

Measure: Response on General Anxiety Disorder 7 item (GAD-7)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: changes in scores This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)

Measure: Change in General Anxiety Disorder 7 item (GAD-7)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: Less than or equal to 12 This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Remission on Beck Depression Inventory (BDI-II)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: 50% Reduction in Score This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Response on Beck Depression Inventory (BDI-II)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: changes in scores This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)

Measure: Change on Beck Depression Inventory (BDI-II)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: Score of 0 This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 0 - 38 (total score) Lower scores indicate lower severity of suicidal ideation (i.e., better outcome) Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)

Measure: Remission on Beck Scale for Suicidal Ideation (SSI)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: changes in scores This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 0 - 38 (total score) Lower scores indicate lower severity of suicidal ideation (i.e., better outcome) Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)

Measure: Change on Beck Scale for Suicidal Ideation (SSI)

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: changes in scores

Measure: Change in WHO Disability Assessment Schedule (WHODAS) Range 0-38

Time: Up to 10 days (From screening/baseline to end of the acute treatment)

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Description: Includes number of treatment days needed and number going on to receive ECT

Measure: Proportion of Patients Maintaining Response During Relapse Prevention

Time: 24 weeks (Tapering and Relapse prevention phase)

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