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THC for Type 2 Diabetes
Phase 1
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male subjects must be willing to use clinically acceptable method of contraception during the entire study
Females of child bearing potential must agree to use two methods of contraception during the entire study
Must not have
History of seizures, head trauma, or other history of CNS insult that could predispose the participant to seizures
Unable or unwilling to follow the study protocol or who are non-compliant with screening appointments or study visits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Summary
This trial will study the effects of THC on blood sugar metabolism and heart health in people with Type 2 diabetes.
Who is the study for?
Adults aged 21-70 with Type 2 Diabetes, a BMI over 25 kg/m2, and stable diabetes medication for at least 3 months can join. They must not use tobacco or THC products recently, have no significant illnesses or heart issues, and agree to contraception if of childbearing potential.
What is being tested?
The trial is testing the effects of THC on glucose metabolism in Type 2 Diabetes patients compared to a placebo. Participants will undergo blood tests and other assessments before and after two weeks of treatment to measure changes.
What are the potential side effects?
Potential side effects from THC may include anxiety, paranoia, mood changes, increased heart rate or low blood pressure. However, individuals with a history of severe reactions to cannabis are excluded from this study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to use contraception throughout the study.
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I agree to use two forms of birth control during the study.
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I am a woman who cannot have children because I am either over a year post-menopausal or have been surgically sterilized.
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I am between 21 and 70 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of conditions like seizures or head injuries that could make me more likely to have seizures.
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I am willing and able to follow the study rules and attend all appointments.
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I have never had a heart attack, stroke, or heart failure.
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My liver is not functioning properly, shown by high enzyme levels or symptoms like jaundice.
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I use insulin to manage my Type 2 Diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Glucose Uptake
Change in Vascular Endothelial Function
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active THCActive Control2 Interventions
Daily, inhaled, flexible dose of cannabis product with THC.
Group II: Placebo CannabisPlacebo Group2 Interventions
Daily, inhaled, flexible dose of cannabis product without THC.
Find a Location
Who is running the clinical trial?
Center for Medicinal Cannabis ResearchOTHER
18 Previous Clinical Trials
599 Total Patients Enrolled
Center For Medicinal Cannabis Research at UC San Diego HealthUNKNOWN
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,575,026 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced serious problems from using cannabis, such as extreme anxiety, paranoia, or severe changes in heart rate or blood pressure.I am willing to use contraception throughout the study.I agree to use two forms of birth control during the study.I have a history of conditions like seizures or head injuries that could make me more likely to have seizures.I am willing and able to follow the study rules and attend all appointments.You currently smoke or use tobacco products.I have never had a heart attack, stroke, or heart failure.I haven't donated a pint of blood in the last 8 weeks.Your hemoglobin level is less than 9 grams per deciliter.My liver is not functioning properly, shown by high enzyme levels or symptoms like jaundice.I have been on stable diabetes medication for over 3 months.Your body mass index (BMI) is higher than 25.I do not have any serious health issues that could increase my risk during the trial.You have a clean drug test result.I am a woman who cannot have children because I am either over a year post-menopausal or have been surgically sterilized.Your HbA1c level is less than 10%.I use insulin to manage my Type 2 Diabetes.I am between 21 and 70 years old.I have not used THC products in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Active THC
- Group 2: Placebo Cannabis
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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