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

NCT04729244 | Unknown Phase 1 FDA Drug

• 1 other identifier: AA00001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pain score

  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.

  4 weeks

Secondary Outcomes (3)

• Anxiety score

  4 weeks

• Insomnia Score

  4 weeks

• Narcotic use reduction

  4 weeks

Study Arms (2)

CBD(hemp oil) cream

ACTIVE COMPARATOR

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

CBD (Hemp oil) Tincture

ACTIVE COMPARATOR

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

Interventions

CBD DRUG

Hemp Oil

Also known as: CBD tincture, CBD cream

CBD (Hemp oil) Tincture; CBD(hemp oil) cream

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Pain and Rehab Specialists: lead
• Hemp synergistics: collaborator

Study Sites (1)

Advanced Pain and Rehab Specialists

Hermitage, Pennsylvania, 16148, United States

Location

MeSH Terms

Conditions

Chronic Pain; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Anuradha Anand, MD

CONTACT

7243087401; anuanand413@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director/Physician

Model Details: One group will be taking CBD tincture, the other will be using CBD cream

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: January 28, 2021
• Study Start: September 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: February 1, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 8 months after publication for 3 years
• Access Criteria: researchers physicians will have access to the data upon request

Locations

US (1)