The Study of Hemp Oil CBD for Evaluation of Efficacy and Safety in Treatment of Pain, Anxiety and Insomnia Management as Well as Effectiveness in Reduction of Opioid Use: The CBD Will be Delivered Via Oil Droplets and Topical Cream Not Containing THC
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|ClinicalTrials.gov Identifier: NCT04729244|
Recruitment Status : Not yet recruiting
First Posted : January 28, 2021
Last Update Posted : January 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|CBD Pain, Chronic Anxiety Insomnia Opioid Use||Drug: CBD||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||One group will be taking CBD tincture, the other will be using CBD cream|
|Masking:||None (Open Label)|
|Official Title:||Critical Review of Efficacy of Hemp Oil (CBD) Tincture and Cream for Treatment of Pain, Anxiety, Insomnia and Reduction of Opioid Use|
|Estimated Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
Active Comparator: CBD(hemp oil) cream
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.
Active Comparator: CBD (Hemp oil) Tincture
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.
- Pain score [ Time Frame: 4 weeks ]
Pain will be reported weekly using the Numeric Rating Scale. On initial evaluation and 4 th 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.
- Anxiety score [ Time Frame: 4 weeks ]Hamilton Anxiety scale will be used to assess change in anxiety score at the beginning and end of the study. The two scores will be used to assess any improvement
- Insomnia Score [ Time Frame: 4 weeks ]Sleep Quality Assessment at the beginning and end of the study and the difference will be used to assess any improvement
- Narcotic use reduction [ Time Frame: 4 weeks ]Using Prescription Drug Monitoring Program at the beginning and end of the study to asses any reduction in medication.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729244
|Contact: Anuradha Anand, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Advanced Pain and Rehab Specialists|
|Hermitage, Pennsylvania, United States, 16148|
|Contact: Anuradha Anand, MD 724-308-7401 email@example.com|