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Cannabinoid

High Ratio CBD:THC vs. High Ratio THC:CBD Cannabis Oil for Stress and Inhibition in Cannabis Users (CAPU RISE Trial)

Phase 1
Recruiting
Led By Christian G Schütz, MD PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have used cannabis for non-medical purposes at least once per week for the past month (30 days), including at least 2 times via oral route of administration
Are 19-35 years old at the start of the study
Must not have
Are hypersensitive to CBD and/or THC and/or have ever had an adverse reaction (an unwanted and unexpected reaction), to less than 40mg of CBD and/or 10mg THC
Have a major physical problem/health concern, including: Liver-cirrhosis or other liver disease Diabetes Chronic illness that may increase risk for adverse reactions to cannabis Chronic pain Genetic glucuronidation disorders (e.g., Gilbert's disease) Cardiovascular disease, including ischemic heart disease with unstable angina or recent acute coronary syndrome in the last 3 months, uncontrolled arrhythmias, poorly controlled hypertension or high blood pressure (e.g., 130/80), or severe heart failure Delirium: active delirium or recent delirium < 7 days, or at significant risk of delirium due to multiple comorbidities (e.g., very elderly, cognitive impairment, cerebrovascular disease) and contributing drugs (e.g., alcohol, stimulants, high doses of benzodiazepines, opioid, sedatives, psychoactive medications)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; average of 1 year

Summary

This trial is examining the neurological effects of cannabis on stress reactivity and inhibition in healthy cannabis and stimulant co-users, with the expectation that high ratio CBD:THC cannabis oil will have the largest effect and low ratio CBD:THC cannabis oil will have a moderate effect on outcome measures compared to placebo.

Who is the study for?
This trial is for healthy cannabis users aged 19-35 who frequently use cannabis and alcohol, but do not take certain medications or have conditions that affect the brain, heart, liver, or metal in their body. Participants must be right-handed, non-pregnant, using effective contraception methods and able to attend study sessions.
What is being tested?
The trial tests how different types of cannabis oil (high THC:CBD ratio vs high CBD:THC ratio) versus a placebo affect stress response and impulse control in regular cannabis users. It's a Phase I study focusing on neurological outcomes.
What are the potential side effects?
Potential side effects may include typical reactions to cannabis such as altered senses or mood changes, dizziness, dry mouth, impaired memory or concentration. Individual responses can vary greatly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have used cannabis weekly for the last month, including twice orally.
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I am between 19 and 35 years old.
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I have received 2 doses of an approved COVID-19 vaccine.
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I have had heavy drinking episodes in the past year.
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I have used at least 20mg of CBD before.
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I have used at least 5mg of THC before.
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I am not trying to become pregnant or using fertility treatments during the study.
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I am between 19 and 35 years old.
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I have not used MDMA/ecstasy/molly.
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I take at least 50 mg of CBD on average.
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I use at least 10 mg of THC on average.
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I will not donate sperm during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic or have had bad reactions to CBD or THC.
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I have a major health issue like liver disease, diabetes, chronic pain, heart problems, or risk of delirium.
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I am taking medications that may affect my brain, heart, or metabolism.
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I cannot attend all the study sessions as scheduled.
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I am not pregnant, nursing, or I am using effective birth control.
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I have been diagnosed with a sleep disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in incidence of adverse events of cannabinoids across conditions
Change in stress response across conditions
Procedure feasibility
+1 more
Secondary study objectives
Change in performance on behavioral impulsivity tasks across conditions
Change in psychological distress across conditions
Change in sleep quality across conditions
+2 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Cannabis oil with a high ratio of THC to CBDActive Control1 Intervention
Participants will be given a single dose of oral cannabis oil containing 5mg THC and 0.17mg CBD.
Group II: Cannabis oil with a high ratio of CBD to THCActive Control1 Intervention
Participants will be given a single dose of oral cannabis oil containing 5mg THC and 25mg CBD.
Group III: PlaceboPlacebo Group1 Intervention
Participants will be given a single dose of 1 mL placebo (carrier oil with botanical terpenes) via oral route of administration.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,436 Total Patients Enrolled
Christian G Schütz, MD PhDPrincipal InvestigatorUniversity of British Columbia; British Columbia Mental Health and Substance Use Services
Karina A Thiessen, BA BEdStudy DirectorUniversity of British Columbia

Media Library

Cannabis oil with a high ratio of CBD to THC (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05261321 — Phase 1
Healthy Subjects Research Study Groups: Cannabis oil with a high ratio of THC to CBD, Cannabis oil with a high ratio of CBD to THC, Placebo
Healthy Subjects Clinical Trial 2023: Cannabis oil with a high ratio of CBD to THC Highlights & Side Effects. Trial Name: NCT05261321 — Phase 1
Cannabis oil with a high ratio of CBD to THC (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05261321 — Phase 1
~0 spots leftby Dec 2024
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