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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04729244
Recruitment Status : Not yet recruiting
First Posted : January 28, 2021
Last Update Posted : August 6, 2021
Sponsor:
Collaborator:
Hemp synergistics
Information provided by (Responsible Party):
Anuradha Anand, Advanced Pain and Rehab Specialists

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
CBD Pain, Chronic Anxiety Insomnia Opioid Use Drug: CBD Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group will be taking CBD tincture, the other will be using CBD cream
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Critical Review of Efficacy of Hemp Oil (CBD) Tincture and Cream for Treatment of Pain, Anxiety, Insomnia and Reduction of Opioid Use
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pain score [ Time Frame: 4 weeks ]

    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.



Secondary Outcome Measures :
  1. Anxiety score [ Time Frame: 4 weeks ]

    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.


  2. Insomnia Score [ Time Frame: 4 weeks ]

    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.


  3. Narcotic use reduction [ Time Frame: 4 weeks ]

    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.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729244


Contacts
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Contact: Anuradha Anand, MD 7243087401 anuanand413@gmail.com

Locations
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United States, Pennsylvania
Advanced Pain and Rehab Specialists
Hermitage, Pennsylvania, United States, 16148
Contact: Anuradha Anand, MD    724-308-7401    aanand@painrehabspecialists.com   
Sponsors and Collaborators
Advanced Pain and Rehab Specialists
Hemp synergistics
More Information
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Responsible Party: Anuradha Anand, Medical Director/Physician, Advanced Pain and Rehab Specialists
ClinicalTrials.gov Identifier: NCT04729244    
Other Study ID Numbers: AA00001
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: August 6, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Age, sex, medical conditions
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 8 months after publication for 3 years
Access Criteria: researchers physicians will have access to the data upon request

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Chronic Pain
Anxiety Disorders
Mental Disorders
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pain
Neurologic Manifestations