PI Name: Kent Hutchison, PhD
COMIRB #: 21-5122
Version Date: 04.20.2023
Thank you for your interest in the ECHO Study. There are a few things about this study that you may like to know before you decide to participate: This study plans to learn more about cannabidiol (CBD) in reducing pain, opioid use, and opioid craving. You are being asked to be in this research study because you have expressed a desire to use CBD to reduce your opioid use. If you join the study, you will be randomized to receive one of three study medications that you will take for a period of 12 weeks: 210 mg/day of CBD that includes trace amounts of THC (< 0.3%), 210 mg/day of CBD that includes no THC, or 210 mg/day of Hemp Seed Oil, which does not contain any CBD or THC. You will not know which medication group you are in until the completion of the study. There will be a study visit approximately each week during the 12-week period you are taking the study medication, with another online follow up visit at Week 16. The first study visit will take place at the University of Colorado Anschutz Medical Campus (AMC). There will be three more in-person study appointments either at AMC or in our Mobile Lab that will be parked near your home. You will be contacted by Zoom each remaining week during the 12-week period. Visits may include a breathalyzer test, a blood draw, a urine drug and pregnancy screen, and surveys and questionnaires, depending on the week. Total study participation will last 16 weeks. Total compensation for the study can be up to $250. Before we schedule your first appointment, it would be helpful to see if you are likely to qualify to be in the study. In order to do this, I would like to ask you some eligibility questions, which will include questions about your health, including prior and current alcohol and drug use. It should take about 10 minutes to go through these questions. Some of the questions may make you uncomfortable; you do not have to answer any question that you would not like to answer, but without answers to these questions, you will not be eligible to participate in the study. We will not save your name or any other information that would identify you until we know you have qualified for the study; at that time, we will keep this information secure. If you do not qualify for this study, we will immediately destroy any information we have collected. We are also required to give you the number of COMIRB, the Ethics Board that oversees our research: it is 303.724.1055, in case you have any questions or concerns for them.
Today's Date:
* must provide value
Today M-D-Y
First name:
* must provide value
Last name:
* must provide value
Email:
* must provide value
Phone:
* must provide value
Preferred contact method (e.g., call, text, or email):
Where did you see the advertisement?
* must provide value
Facebook Instagram Reddit Twitter Anschutz Email Flyer in the Mail Doctor's Office Pain Clinic Friend or Family Member Other
What is your date of birth? (M-D-Y)
* must provide value
Today M-D-Y
Male
Female
Transgender
Other
Where is the origin of your chronic pain?
In the past 7 days, how would you rate your pain level on average?
* must provide value
0 (No Pain)
1
2
3
4
5
6
7
8
9
10 (Worst pain imaginable)
Have you ever used prescription (or non-prescription) medications for your pain?
Yes
No
Do you currently use prescription (or non-prescription) medications for pain?
* must provide value
Yes
No
Please list the names of the prescription (and non-prescription) medications you use for your pain along with the average dose and frequency: Example: Percocet, 2.5/325mg, 1x/day Meloxicam, 7.5mg, 2x/day Tylenol, 500mg, 3x/day
* must provide value
When did you first start taking these medications regularly (1x per week, 1x per month)? Include month and year.
Example: Percocet, 05/2018 Meloxicam, 07/2021 Tylenol, 10/2020
* must provide value
When is the last time you took these medications? Include month and year.
* must provide value
Do you currently use cannabidiol (CBD) for medicinal purposes?
* must provide value
Yes
No
If yes, please describe the frequency, dose, and purpose of your CBD use (e.g. 1x daily, 200mg CBD, lower back pain).
Are you interested in using cannabidiol (CBD) to reduce your pain and/or opioid medication?
* must provide value
Yes
No
Do you wish to reduce your pain and/or opioid medication?
* must provide value
Yes
No
Do you use opioids in larger amounts or for longer than you mean to?
* must provide value
Yes
No
Do you want to cut down or stop using opioids but cannot manage to?
* must provide value
Yes
No
Do you spend a lot of time getting, using, or recovering from opioid use?
* must provide value
Yes
No
Do you have cravings or urges to use opioids?
* must provide value
Yes
No
Are you unable to manage to do what you should do at work, home, or school because of opioid use?
* must provide value
Yes
No
Do you continue to use opioids even when it causes problems in relationships?
* must provide value
Yes
No
Do you give up important social, occupational, or recreational activities because of opioid use?
* must provide value
Yes
No
Do you use opioids again and again, even when it puts you in danger?
* must provide value
Yes
No
Do you continue to use opioids, even when you know you have a physical or psychological problem that could have been caused or made worse by opioid use?
* must provide value
Yes
No
Do you need to use more opioids to get the effect you want?
* must provide value
Yes
No
Have you developed withdrawal symptoms, which can be relieved by more opioid use?
* must provide value
Yes
No
Do you drink alcohol in larger amounts or for longer than you mean to?
* must provide value
Yes
No
Do you want to cut down or stop drinking but cannot manage to?
* must provide value
Yes
No
Do you spend a lot of time getting, using, or recovering from drinking?
* must provide value
Yes
No
Do you have cravings or urges to drink alcohol?
* must provide value
Yes
No
Are you unable to manage to do what you should do at work, home, or school because of drinking?
* must provide value
Yes
No
Do you continue to drink even when it causes problems in relationships?
* must provide value
Yes
No
Do you give up important social, occupational, or recreational activities because of drinking?
* must provide value
Yes
No
Do you drink alcohol again and again, even when it puts you in danger?
* must provide value
Yes
No
Do you continue to drink, even when you know you have a physical or psychological problem that could have been caused or made worse by drinking alcohol?
* must provide value
Yes
No
Do you need to drink more alcohol to get the effect you want?
* must provide value
Yes
No
Have you developed withdrawal symptoms, which can be relieved by drinking more alcohol?
* must provide value
Yes
No
Have you used cannabis/marijuana in the last 30 days? This includes CBD-only products and hybrid (CBD/THC) products.
* must provide value
Yes
No
On average, how many days per month do you use cannabis? If you're a daily user, please enter 30.
What type of cannabis product did you use (e.g., THC, CBD, hybrid)?
Do you use any recreational drugs, like ecstasy, cocaine or methamphetamine?
* must provide value
Yes
No
Please list drug(s) used:
When was the last time you used any of the above? Date(s)
Are you actively seeking or in treatment for any substance use disorder, besides opioid use disorder?
* must provide value
Yes
No
Please briefly describe what substance use disorder treatment you seeking or currently in now:
* must provide value
Are you currently prescribed any medications for the treatment of epilepsy, including clobazam, sodium valproate, etc.?
* must provide value
Yes
No
Please enter the name of the medication and briefly describe why you are taking this medication:
* must provide value
Are you currently prescribed buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, lamotrigine, and/or teriflunomide?
* must provide value
Yes
No
Please enter the name of the medication and briefly describe why you are taking this medication:
* must provide value
Do you currently use any other prescription medication?
* must provide value
Yes
No
Please list the name of the medication(s) and their purpose. Example:Zoloft/Depression
* must provide value
Have you had any serious medical illnesses within the past 6 months (e.g., heart attack, cancer diagnosis, renal or liver disease)?
* must provide value
Yes
No
Has a doctor ever told you that you have a psychiatric diagnosis such as bipolar disorder, depression, anxiety, psychotic disorder, schizophrenia or any other disorder?
* must provide value
Yes
No
Are you currently being treated?
Yes
No
Are you pregnant?
* must provide value
No
Yes
NA/Male
Are you planning to get pregnant in the next 6 months?
* must provide value
No
Yes
NA/Male
Are you willing to have a pregnancy test if you are eligible for the study?
* must provide value
No
Yes
NA/Male
Do you have access to the internet (whether by computer, smartphone, or another device) such that you could complete online surveys during your participation in this study?
* must provide value
Yes
No
Participating in this study involves the collection of three blood samples over the course of 12 weeks. Would you be willing to have your blood drawn by a member of our staff who is trained in blood draw procedures?
* must provide value
Yes
No
Are you willing to come to the CU Anschutz Medical Campus in Aurora, CO for in-person appointments?
* must provide value
Yes
No