The Study of Hemp Oil CBD for Evaluation of Efficacy and Safety in Treatment of Pain, Anxiety and Insomnia Management

Study Overview
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Brief Summary
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The investigators are looking to conduct a study looking at the effects of cannabidiol (CBD) from Hemp Oil in patients with Chronic pain, anxiety and insomnia. It is believed that CBD will improve pain anxiety and sleep quality and reduce opioid use. The study will last a total of 4 weeks and involve onsite visits in addition to weekly pain assessments.

Detailed Description
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The proposal is to conduct a interventional cohort pilot study to evaluate the effectiveness of CBD on the management of chronic pain, anxiety and insomnia. Subjects will be pre-screened from new and existing patients as well as from referral sites for the diagnosis of chronic pain. Potential subjects will be screened for pain >3 months who are using oral analgesic including narcotics and or physical therapy to reduce pain. Those meeting all inclusion and exclusion criteria will receive a comprehensive history and physical exam and undergo informed consented at the Screening Visit. Baseline survey data will be collected including various pain rating surveys. The patient's will be monitored for compliance to complete the weekly rating using a research phone application. Subjects will receive either CBD tincture or CBD topical cream.This will be dosed daily for a total of 4 weeks. Patients will be evaluated on three pain rating scales: On initial evaluation and 4th week evaluation, patients will be asked to fill out The Brief Pain Inventory and Pain Disability Index. Once weekly, a Numeric Rating Scale. On initial evaluation and at 4th week evaluation, narcotic dosing will be reviewed and recorded. Quality of sleep and anxiety scale will also be recorded for the four weeks using the Hamilton Anxiety scale and Sleep Quality Assessment at the start and end of the 4 weeks. At initiation and conclusion of study blood work to evaluated levels of CBD in each patient. Subjects will be screened for side effects as well as records of pain medication use throughout the duration of the study

Official Title
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Critical Review of Efficacy of Hemp Oil (CBD) Tincture and Cream for Treatment of Pain, Anxiety, Insomnia and Reduction of Opioid Use

Conditions
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CBD, Pain, Chronic, Anxiety, Insomnia, Opioid Use

Intervention / Treatment
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* Drug: CBD


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with pain >3 months who are using oral analgesic including narcotics and or physical therapy to reduce pain. Patient provides informed consent Older than 21 years old, Previously have used CBD or marijuana Speaks English Exclusion criteria: Patients who are receiving interventional pain procedures or surgery within 30 days for their pain Patients who have had pain <3 months Presence of serious medical illness Pregnant females Use of P450 modifying medications.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will be taking CBD tincture, the other will be using CBD cream
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBD(hemp oil) cream<br>cream 2000mg/1oz (50mg/dose) once daily dosing for a total of 4 weeks to area of most pain.Patients will record outcome in pain, anxiety, sleep, and report any adverse effects. | Drug: CBD<br>* Hemp Oil<br>* Other names: CBD cream;|
| Active Comparator: CBD (Hemp oil) Tincture<br>1500mg CBD/30ml (50mg/dose) once daily dosing for total of 4 weeks. Patients will record outcome in pain, anxiety, sleep, and report any adverse effects. | Drug: CBD<br>* Hemp Oil<br>* Other names: CBD cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain will be reported weekly using the Numeric Rating Scale. On initial evaluation and 4 week evaluation, patients will be asked to fill out The Brief Pain Inventory and Pain Disability Index. The primary study endpoint will be compared between groups using the area under the curve. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score | Hamilton Anxiety scale will be used to assess change in anxiety score at the beginning and end of the study. The two scores will be used to assess any change in anxiety. Hamilton Anxiety Rating Scale (HAM-A) Assessment on 14 items on a scale of 0 to 4. Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. A higher score is a worse outcome. | 4 weeks | 
| Insomnia Score | Sleep Quality Assessment at the beginning and end of the study and the difference will be used to assess any change. Sleep Quality Assessment is based on The Pittsburgh Sleep Quality Index (PSQI), an effective clinical tool to assess sleep quality and efficiency. It differentiates poor from good sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances The sum of the scores of the seven components is used to compute the global sleep quality score, ranging in value from 0 to 21. A score of 0 indicates no sleep difficulties, while more-severe sleep difficulties correspond to higher values for the global and component scores. | 4 weeks | 
| Narcotic use reduction | Using Prescription Drug Monitoring Program at the beginning and end of the study to asses any change in medication. The Prescription Drug Monitoring Program (PDMP) is an online database that houses prescribing and dispensing data for patients per state. It calculates MME. The total daily morphine milligram equivalents (MME) will be displayed on a patients profile. 0 means no narcotic use and higher values show high narcotic use which is a worse outcome. | 4 weeks |