Anxiety Clinical Trial - The Study of Hemp Oil CBD for Evaluation of

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Anxiety
Anxiety Disorders
CBD
Chronic Pain
Insomnia
Opioid Use
Pain, Chronic
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT04729244
Study type	Interventional
Source	Advanced Pain and Rehab Specialists
Contact	Anuradha Anand, MD
Phone	7243087401
Email	anuanand413@gmail.com
Status	Not yet recruiting
Phase	Phase 1
Start date	September 1, 2021
Completion date	February 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05777044` - The Effect of Hatha Yoga on Mental Health	N/A
Recruiting	`NCT04680611` - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed	`NCT04512768` - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy	N/A
Completed	`NCT04748367` - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care	N/A
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT04579354` - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia	N/A
Completed	`NCT03457714` - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Completed	`NCT03535805` - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances	N/A
Recruiting	`NCT05956912` - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting	`NCT05302167` - Molehill Mountain Feasibility Study.	N/A
Completed	`NCT05588622` - Meru Health Program for Cancer Patients With Depression and Anxiety	N/A
Completed	`NCT05881681` - A Mindfulness Approach to UA for Afro-descendants	N/A
Active, not recruiting	`NCT04961112` - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits	N/A
Completed	`NCT05980845` - The Effect Nature Sounds and Music on Hemodialysis Patients	N/A
Terminated	`NCT04612491` - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting	`NCT05449002` - Digital Single Session Intervention for Youth Mental Health	N/A
Completed	`NCT05585749` - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients	N/A
Terminated	`NCT03272555` - WILD 5 Wellness: A 30-Day Intervention	N/A
Recruiting	`NCT05997849` - Development of a Multiplatform Mental Health Mobile Tool	N/A
Completed	`NCT06421233` - The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms