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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Anxiety; Opioid Use; Pain, Chronic; CBD
• Intervention / Treatment: Drug: CBD

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Anuradha Anand, MD; Phone Number: 7243087401; Email: anuanand413@gmail.com

Study Locations

• United States
  • Pennsylvania
    • Hermitage, Pennsylvania, United States, 16148
      • Advanced Pain and Rehab Specialists
      • Contact: Anuradha Anand, MD; Phone Number: 724-308-7401; Email: aanand@painrehabspecialists.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CBD(hemp oil) cream; 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; Hemp Oil; Other Names: CBD tincture; CBD cream
Active Comparator: CBD (Hemp oil) Tincture; 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; Hemp Oil; Other Names: CBD tincture; CBD cream

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Advanced Pain and Rehab Specialists
• Collaborators: Hemp synergistics

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 1, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pain; Neurologic Manifestations; Chronic Pain; Sleep Initiation and Maintenance Disorders; Anxiety Disorders
• Other Study ID Numbers: AA00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Age, sex, medical conditions
• IPD Sharing Time Frame: 8 months after publication for 3 years
• IPD Sharing Access Criteria: researchers physicians will have access to the data upon request
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No