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

Advanced Pain and Rehab Specialists

Status and phase: Unknown; Phase 1

Conditions: Insomnia; Pain, Chronic; Opioid Use; CBD; Anxiety

Treatments: Drug: CBD

Study type: Interventional

Funder types: Other

Identifiers

NCT04729244

AA00001

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

CBD(hemp oil) cream

Active Comparator group

Description:

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.

Treatment:

Drug: CBD

CBD (Hemp oil) Tincture

Active Comparator group

Description:

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.

Treatment:

Drug: CBD