Study Title: Assessment of Oral Cannabidiol on Symptoms of Anxiety

You are invited to participate in a research study to evaluate the effectiveness of Cannabidiol (CBD) to provide relief of stress, and Anxiety in Healthy Adults. This study is being sponsored by Panacea Life Sciences and led by James W. Baumgartner, Ph.D.
We ask that you read this form and ask any questions prior to agreeing to participate in this study.  If you consent to enter the study and agree to participate, please indicate agreement in the sections below and enter in contact information.

Background and Purpose
Panacea Life Sciences is a Limited Liability Company that manufacture dietary supplements.  Panacea conducts scientific studies, including open-label clinical studies to assess health benefits of dietary supplements.  In this study, Panacea is recruiting health adults to participate in assessing oral cannabidiol will improve perceived stress and anxiety in healthy adults. The majority of subjects enrolled will not be currently taking medications, however those on current medications are allowed to participate.  Participants will receive Panacea cannabidiol products at a dose of 50-60 mg CBD per day.   Participants will be asked to complete an anxiety assessment questionnaire prior to enrollment and after 2 weeks of CBD supplementation.

The objective of the study is to:
1. Evaluate the efficacy of test products as options for management of people who experience stress or have anxiety.  
2. Evaluate two different dosage forms for the ability to alleviate anxiety.
3. Assess palatability, ease of administration, and potential for side effects associated with administration of the test products.

Cannabidiol has been reported to have a potential benefit for treating a wide range of conditions (e.g. osteoarthritis, anxiety, neurologic and endocrine disease and drug-resistant infections). We are evaluating this product in stages to determine how best it can be utilized to improve the quality of life of patients with the aforementioned conditions as a sole agent or as an adjunct to more
traditional therapies.

Study Procedures:
Assessment:  Upon consenting to participate in the study, subjects will be asked to complete a questionnaire to assess current state of stress or anxiety.  The purpose of the questionnaire is to establish a baseline level of stress so that CBD supplementation effects may be measured. 
Study Supplement:  Consenting subjects will take the provided FAST product, 25 mg CBD per tablet, twice daily; or a 20 mg CBD full spectrum hemp oil soft gel, three times daily.  Preference for the study material is indicated at the end of this form.
Ongoing Assessment:  At 2 weeks participants will be asked to complete the stress and anxiety assessment.  At the end of the study subjects will receive an additional bottle of product corresponding to what was taken during the study as compensation and appreciation for participation in the trial. Participants should continue on any medication or therapies, but ask that these be reported in the surveys. 

Risks of study participation:  During the course of the study subjects may experience side effects from the CBD supplement including diarrhea, vomiting, or lethargy. While other undesirable side effects may occur, the dose of CBD used in this study is well below doses used in other studies that established safe, tolerable doses of the product. As a consequence, should any of the aforementioned side effects occur, or if subjects have increased feelings of anxiety or depression, they should immediately stop taking the CBD product, contact their primary health provider as well as contact Panacea Life Sciences as soon as conv
Benefits of study participation:
The benefits to study participation may include but not be limited to:
1. A more comprehensive understanding of how the cannabidiol may be used to reduce symptoms of anxiety, including any potential side effects.
2. Improved knowledge on dosing that include mg CBD per body weight, dose format and whether pure CBD is more effective than a full spectrum product.
3. Establishing CBD as an adjunct to current standards of care relating to the treatment of patients with
anxiety.

Study costs/compensation: Participants will be provided the test product for the duration of the study
period at no cost. The test product will be shipped directly to participants. Therefore, there are no direct costs
to participating owners in this study. In the unlikely event of side effects associated with this product, subjects  
will be responsible for any treatment costs incurred during the study period to treat perceived or actual side
effects. Subjects that complete the study will receive a free additional bottle of product and a 10% discount for
an annual subscription of product in thanks for participation.

Confidentiality: All results will be confidential. Information obtained in the study may be used in scientific
presentations and/or publication. If participating, Panacea Life Sciences will reserve the right to utilize the data for reporting or marketing purposes to demonstrate product effectiveness. However, no personal oridentifying information about any participantsyou will be released.

Voluntary Participation: Participation in this study is voluntary. Your decision whether or not to participate in
this study will not affect your current or future relations with your healthcare provider. If you decide to participate,
you are free to withdraw at any time without affecting those relationships.
Please do not hesitate to contact us if you have any questions or concerns about this study.

Primary Investigator: Dr. James Baumgartner – Office phone: 720-639-6174, email:
James.Baumgartner@panacealife.com.

Question Title

* 1. How will your Privacy be Protected?
Authorization to Use or Disclose (Release) Health Information for Research

Panacea Life Sciences, Principal Investigator, and the study team follow federal and state laws to protect your privacy, including the Health Insurance Portability and Accountability Act (HIPAA). Your permission for the Use and Disclosure of your information is called “Authorization.”  If you choose not to sign this Authorization, you cannot take part in the research study.  Refusing to sign this form will not affect your present or future health care, payment for your health care, or any other benefits to which you are otherwise entitled. Your Authorization will allow the use or disclose (release) your health information for this study.

The health information that we may use or disclose (release) for this research includes age, race, gender, height and weight at the time of the study. 

The health information listed above may be used by and/or disclosed (released) to the following as applicable:
·   Researchers and research staff,
·   Applicable Institutional Review Board
·   Representatives of Panacea Life Sciences,
·   Domestic and foreign agencies that regulate research such as the US Food and Drug Administration, Office of Civil Rights, and Office for Human Research Protections,
·   Others as required by law.

The purposes of these uses and disclosures are to (1) conduct the study and (2) make sure the study is being done correctly.  Once your health information has been disclosed under this authorization, it may no longer be protected by federal privacy laws (such as HIPAA). The individuals who receive your health information may share your information with others without your additional permission.

This Authorization will expire when the research activities are complete including data monitoring and data analysis. You may change your mind and revoke (take back) this Authorization at any time, except to the extent that the researchers have already used or disclosed your health information based on this Authorization. To revoke this Authorization, you must write to the Principal Investigator noted on the first page of this informed consent document. If you revoke this Authorization, you may no longer be allowed to participate in this research study. If you also agree to allow your health information to be used in future research, you will need to specify whether the revocation applies to only this study or if it also includes the future research.

To maintain the integrity of this research study, you generally will not have access to your personal health information related to this research until the study is complete. If it is necessary for your care, your health information will be provided to you or your physician.

Your  electronic signature below indicates that you authorize the use and disclosure of your information as described in this document.  Please initial in box below.

Question Title

* 2. WHO SHOULD I CONTACT IF I HAVE QUESTIONS ABOUT THIS STUDY?
Contact the Panacea Life Sciences Health Desk at help@panacealife.com or      1 (800) 985-0515  for any of the following reasons:
·       if you have any questions about your participation in this study, 
·       if you feel you have had a research-related injury or a reaction to the study drug, device or procedure, or
·       if you have questions, concerns or complaints about the research.

Please initial in box below

Question Title

* 3. I have read the information regarding the study design and risks associated with study participation. I have asked questions and have received answers. I consent to participate
in the study.

Question Title

* 4. FOR PARTICIPANT/LEGALLY AUTHORIZED REPRESENTATIVE

I have read this consent form or it has been read to me. My questions about the research study and my participation in it have been answered. By initialing the box below, I voluntarily give my consent to participate in the research study and I authorize my health information to be used and disclosed as described earlier in this consent form.

 

Question Title

* 5. Contact information

Question Title

* 6. What is your gender?

Question Title

* 7. Age 

Question Title

* 8. Body Weight

Question Title

* 9. Are you currently taking any medications?  If so, please list

Question Title

* 10. Do you prefer to receive sublingual CBD isolate product or full spectrum soft gels (these will have 0.3% THC) for your study participation?

T