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

Sponsor
Advanced Pain and Rehab Specialists (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04729244
Collaborator
Hemp synergistics (Other)
30
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Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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 creamOne 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
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

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

    Primary Outcome Measures

    1. Pain score [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 [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Advanced Pain and Rehab Specialists Hermitage Pennsylvania United States 16148

    Sponsors and Collaborators

    • Advanced Pain and Rehab Specialists
    • Hemp synergistics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anuradha Anand, Medical Director/Physician, Advanced Pain and Rehab Specialists
    ClinicalTrials.gov Identifier:
    NCT04729244
    Other Study ID Numbers:
    • AA00001
    First Posted:
    Jan 28, 2021
    Last Update Posted:
    Aug 6, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 6, 2021