Endourage Complete Spectrum Oral Mucosal Drops (OMD) in Adults Desiring a Reduction in Ethanol Use
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Alcohol Abstinence
- Alcohol Drinking
- Alcohol Use, Unspecified
- Alcohol Related Disorders
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: This is a 112-day, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of Endourage 1200 mg Complete Spectrum Oral Mucosal Drops (OMD ™). A total of 32 study participants will be enrolled. Placebo (Hemp seed oil and peppermint flavoring) Isolate (CBD no terpenes Hemp seed oil [slightly lower concentration of CBD ratio]) Endourage OMD (Full flower extract with a 1:1 ratio of cannabis terpenes, Hemp seed oil and peppermint flavoring)Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The study will be double-blind; neither the Investigator nor the study participant will know to which study treatment arm the participant is assigned. All 3 study treatments will be packaged in identical bottles and similar labelling. Study treatment dispensing and return will be managed centrally; study treatment will be mailed directly to study participants. The 2 control test articles have been designed and flavored to look and taste like OMD study product.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
CBD is the second most abundant component of the cannabis plant after tetrahydrocannabinol (THC). Unlike THC, CBD does not get users high, but there is some evidence suggesting that it might have anti-anxiety, anticonvulsant, anti-inflammatory and immune boosting, antioxidant effects. Currently, the...
CBD is the second most abundant component of the cannabis plant after tetrahydrocannabinol (THC). Unlike THC, CBD does not get users high, but there is some evidence suggesting that it might have anti-anxiety, anticonvulsant, anti-inflammatory and immune boosting, antioxidant effects. Currently, the only CBD product approved by the Food and Drug Administration is a prescription oil called Epidiolex (Greenwich Biosciences, Inc. 2018). It is approved to treat two types of epilepsy. Aside from Epidiolex, state laws on the use of CBD vary. While CBD is being studied as a treatment for a wide range of conditions, including Parkinson's disease, schizophrenia, diabetes, multiple sclerosis and anxiety, and addiction, research supporting the drug's benefits is still limited. CBD use carries some risks. Though it is often well-tolerated, CBD can cause side effects, such as dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. CBD can also interact with other medications you are taking, such as blood thinners. Another cause for concern is the unreliability of the purity and dosage of CBD in products. A recent study of 84 CBD products bought online showed that more than a quarter of the products contained less CBD than labeled. In addition, THC was found in 18 products. If you plan to use products containing CBD, talk to your primary health care provider. People take cannabidiol by mouth for anxiety, bipolar disorder, a muscle disorder called dystonia, seizures, multiple sclerosis, Parkinson's disease, and schizophrenia. Cannabidiol is possibly safe when taken by mouth and appropriately in adults. Cannabidiol doses of up to 300 mg daily have been used safely for up to 6 months. Higher doses of 1200-1500 mg daily have been used safely for up to 4 weeks. Cannabidiol sprays used under the tongue have been used in doses of 2.5 mg for up to 2 weeks.
Tracking Information
- NCT #
- NCT04659278
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Thomas P Young, PhD NP Michael D Steward, MD + Thomas P Young, PhD, NP
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