Clinical trial NCT04729244: The Study of Hemp Oil CBD for Evaluation of Efficacy and Safety in Treatment of Pain, Anxiety and Insomnia Management
Official title: Critical Review of Efficacy of Hemp Oil (CBD) Tincture and Cream for Treatment of Pain, Anxiety, Insomnia and Reduction of Opioid Use
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: CBD
Pain, Chronic
Anxiety
Insomnia
Opioid Use
Lead sponsor: Advanced Pain and Rehab Specialists
Sponsor class: OTHER
Collaborators: name: Hemp synergistics
First posted: 2021-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will be taking CBD tincture, the other will be using CBD cream
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Pain score
timeFrame: 4 weeks
Secondary outcomes:
measure: Anxiety score
timeFrame: 4 weeks
measure: Insomnia Score
timeFrame: 4 weeks
measure: Narcotic use reduction
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hermitage
country: United States
facility: Advanced Pain and Rehab Specialists
state: Pennsylvania
Study officials:
References: