The Study of Hemp Oil CBD for Evaluation of Efficacy and Safety in Treatment of Pain, Anxiety and Insomnia Management
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|ClinicalTrials.gov Identifier: NCT04729244|
Recruitment Status : Not yet recruiting
First Posted : January 28, 2021
Last Update Posted : August 6, 2021
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|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 :||September 1, 2021|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||February 1, 2022|
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 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 change in anxiety.
Hamilton Anxiety Rating Scale (HAM-A) Assessment on 14 items on a scale of 0 to 4. Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. A higher score is a worse outcome.
- 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 change.
Sleep Quality Assessment is based on The Pittsburgh Sleep Quality Index (PSQI), an effective clinical tool to assess sleep quality and efficiency.
It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.
Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances The sum of the scores of the seven components is used to compute the global sleep quality score, ranging in value from 0 to 21. A score of 0 indicates no sleep difficulties, while more-severe sleep difficulties correspond to higher values for the global and component scores.
- Narcotic use reduction [ Time Frame: 4 weeks ]
Using Prescription Drug Monitoring Program at the beginning and end of the study to asses any change in medication.
The Prescription Drug Monitoring Program (PDMP) is an online database that houses prescribing and dispensing data for patients per state.
It calculates MME. The total daily morphine milligram equivalents (MME) will be displayed on a patients profile.
0 means no narcotic use and higher values show high narcotic use which is a worse outcome.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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.
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|
|Responsible Party:||Anuradha Anand, Medical Director/Physician, Advanced Pain and Rehab Specialists|
|Other Study ID Numbers:||
|First Posted:||January 28, 2021 Key Record Dates|
|Last Update Posted:||August 6, 2021|
|Last Verified:||August 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Age, sex, medical conditions|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||8 months after publication for 3 years|
|Access Criteria:||researchers physicians will have access to the data upon request|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases