NCT04729244

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Advanced Pain and Rehab Specialists · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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

Conditions

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

Interventions

Type	Name	Description
DRUG	CBD	Hemp Oil

Timeline

• Start date: 2021-09-01
• Primary completion: 2021-11-01
• Completion: 2022-02-01
• First posted: 2021-01-28
• Last updated: 2021-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study