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Trial record 4 of 4 for:    topical, THC

The Study of Hemp Oil CBD for Evaluation of Efficacy and Safety in Treatment of Pain, Anxiety and Insomnia Management as Well as Effectiveness in Reduction of Opioid Use: The CBD Will be Delivered Via Oil Droplets and Topical Cream Not Containing THC

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ClinicalTrials.gov Identifier: NCT04729244
Recruitment Status : Not yet recruiting
First Posted : January 28, 2021
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
Hemp synergistics
Information provided by (Responsible Party):
Anuradha Anand, Advanced Pain and Rehab Specialists

Tracking Information
First Submitted Date  ICMJE January 25, 2021
First Posted Date  ICMJE January 28, 2021
Last Update Posted Date January 28, 2021
Estimated Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
Pain score [ Time Frame: 4 weeks ]
Pain will be reported weekly using the Numeric Rating Scale. On initial evaluation and 4 th 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
  • 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 improvement
  • 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 improvement
  • Narcotic use reduction [ Time Frame: 4 weeks ]
    Using Prescription Drug Monitoring Program at the beginning and end of the study to asses any reduction in medication.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study of Hemp Oil CBD for Evaluation of Efficacy and Safety in Treatment of Pain, Anxiety and Insomnia Management as Well as Effectiveness in Reduction of Opioid Use: The CBD Will be Delivered Via Oil Droplets and Topical Cream Not Containing THC
Official Title  ICMJE Critical Review of Efficacy of Hemp Oil (CBD) Tincture and Cream for Treatment of Pain, Anxiety, Insomnia and Reduction of Opioid Use
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • CBD
  • Pain, Chronic
  • Anxiety
  • Insomnia
  • Opioid Use
Intervention  ICMJE Drug: CBD
Hemp Oil
Other Names:
  • CBD tincture
  • CBD cream
Study Arms  ICMJE
  • 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.
    Intervention: Drug: CBD
  • 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.
    Intervention: Drug: CBD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 27, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE 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, is older than 21 years old, previously have used CBD or marijuana and 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Anuradha Anand, MD 7243087401 anuanand413@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04729244
Other Study ID Numbers  ICMJE AA00001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Age, sex, medical conditions
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 8 months after publication for 3 years
Access Criteria: researchers physicians will have access to the data upon request
Responsible Party Anuradha Anand, Advanced Pain and Rehab Specialists
Study Sponsor  ICMJE Advanced Pain and Rehab Specialists
Collaborators  ICMJE Hemp synergistics
Investigators  ICMJE Not Provided
PRS Account Advanced Pain and Rehab Specialists
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP