Thank you for your interest in the Tolerability and Efficacy of Hemp-Derived CBD for the Treatment of Alcohol Use Disorder.
If you join the study, you will be randomized to receive one of three study medications that you will take for a period of 8 weeks: 150 mg/day of CBD that includes trace amounts of THC (<0.3%), 150 mg/day of CBD that includes no THC, or 150 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, and we ask that you not use any other form of cannabis during those 8 weeks. There will be a study visit approximately each week during the 8-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. Another six of the visits will be remote, via Zoom. Finally, there will be three study appointments in our Mobile Lab that will be parked near your home. Visits may include a breathalyzer test, a blood draw, a drug and pregnancy screen, an alcohol exposure task, and surveys and questionnaires, depending on the week. Total study participation will last 16 weeks.
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.
May we ask where you saw the advertisement?
Are you still interested in participating?
Yes
No
What is your date of birth?
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Male
Female
Transgender
Other
Do you plan to stay in the Denver area for at least the next 6 months?
Yes
No
Are you currently seeking treatment for your drinking or do you wish to reduce your drinking?
Yes
No
Had times when you ended up drinking more, or longer than you intended?
Yes
No
More than once wanted to cut down or stop drinking, or tried to, but couldn't?
Yes
No
Spent a lot of time drinking? Or being sick or getting over the after effects?
Yes
No
Experienced craving, a strong need, or urge to drink?
Yes
No
Found that drinking or being sick from drinking often interfered with taking care of your home or family? Or caused job troubles? Or school problems?
Yes
No
Continued to drink even though it was causing trouble with your family or friends?
Yes
No
Given up or cut back on activities that were important or interesting to you, or gave you pleasure, in order to drink?
Yes
No
More than once gotten into situations while or after drinking that increased your chances of getting hurt (such as driving, swimming, using machinery, walking in a dangerous area, or having unsafe sex)?
Yes
No
Continued to drink even though it was making you feel depressed or anxious or adding to another health problem? Or after having had a memory blackout?
Yes
No
Had to drink much more than you once did to get the effect you want? Or found that your usual number of drinks had much less effect than before?
Yes
No
Found that when the effects of alcohol were wearing off, you had withdrawal symptoms, such as trouble sleeping, shakiness, irritability, anxiety, depression, restlessness, nausea, or sweating? Or sensed things that were not there?
Yes
No
On average, how many drinks do you have in one drinking occasion? One standard drink is equal to one 12oz can or bottle of beer, one 5oz glass of wine, 1.5oz of hard liquor (1 shot, or 1 mixed drink with 1.5 oz of hard liquor added).
Do you drink more than 4 drinks (for women) or 5 drinks (for men) during at least one drinking day per week?
Yes
No
On average, how many drinks do you have in total each week?
Have you ever experienced severe alcohol withdrawal (e.g., seizure, delirium tremens)?
Yes
No
Do you currently use tobacco products (e.g., cigarettes, E-cigarettes, smokeless tobacco, hooka, dhokha)?
Yes
No
If yes, how many days a week:
How many cigarettes (or equivalent) do you smoke per day?
Have you used cocaine, amphetamines, opioids (e.g., heroin, morphine, oxycodone, OxyContin, fentanyl), or benzodiazepines (e.g., Valium, Xanax, Klonopin, Ativan) in the last 30 days?
Yes
No
Have you used cannabis/marijuana in the last 30 days?
Yes
No
If yes, how many times/month:
If yes, what type of cannabis product did you use (e.g., THC, CBD)?
Do you currently have a diagnosis of any substance abuse disorder, other than Alcohol Use Disorder?
Yes
No
Do you have any charges currently pending for a violent crime (not including DUI-related charges?
Yes
No
Are you currently prescribed any medications for the treatment of epilepsy, including clobazam, sodium valproate, etc.?
Yes
No
Are you currently prescribed disulfiram, naltrexone, topiramate, vivitrol, and/or acamprosate?
Yes
No
Are you currently prescribed buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide?
Yes
No
Have you ever experienced or been told by your doctor that you have an alcohol-related illness (e.g. gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer)?
Yes
No
Do you currently have any serious medical problems that impact your daily life?
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?
Yes
No
If you are receiving treatment for a psychiatric diagnosis, please list the medication(s) you are receiving?
(If applicable) Are you currently pregnant or nursing?
Yes
No
(If applicable) Are you planning to get pregnant in the next 6 months?
Yes
No
(If applicable) Are you willing to have a pregnancy test if you are eligible for the study?
Yes
No
(If applicable) Are you currently using birth control?
Yes
No
If yes, what birth control are you currently using?
Do you have access to the internet (whether by computer, smartphone, or other device) such that you could complete surveys during your participation in this study?
Yes
No
Participating in this study involves the collection of three blood samples over the course of 8 weeks. Would you be willing to have your blood drawn by professional who is trained in blood draw procedures?
Yes
No
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What is your name?
(First name Last name)
What is your email address?
What is your phone number?
Is it ok if we send text messages to the phone number you have provided regarding your appointments/eligibility?
Yes
No
May we leave a voicemail regarding your eligibility/appointments for this study?
Yes
No
What is the best time to contact you?
Are you interested in being contacted by other studies if you are not eligible for this one?
Yes
No