Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure

NCT05261321 | Active Not Recruiting Phase 1

• 1 other identifier: CAPU RISE 1.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Phase I non-therapeutic trial is to examine the neurological effects of cannabis on stress reactivity and inhibition in healthy cannabis users. We expect differences between high ratio CBD:THC cannabis oil, low ratio CBD:THC cannabis oil, and/or placebo on outcome measures.

Conditions

Healthy

Keywords

cannabis; cannabinoids; stress; neuroimaging; fMRI

Outcome Measures

Primary Outcomes (4)

• Change in stress response across conditions

  Indicated by differences in blood-oxygenation-level-imaging (BOLD) response via functional magnetic resonance imaging (fMRI), salivary stress molecule levels (eg cortisol, IgA), heart rate, and self-reports. Participants will fill out a daily diary each morning starting the day after session 1 until the day of session 5 with their self-reports.

  5 weeks

• Change in incidence of adverse events of cannabinoids across conditions

  Assessed through self-reports from study participants (semi-structured interviews) and clinically significant adverse changes in vital signs (heart rate, blood pressure).

  5 weeks

• Procedure feasibility

  Measured via means and rates of study recruitment

  Through study completion; average of 1 year

• Protocol feasibility

  Measured via means and rates of study recruitment

  Through study completion; average of 1 year

Secondary Outcomes (5)

• Change in performance on behavioral impulsivity tasks across conditions

  5 weeks

• Change in sleep quality across conditions

  5 weeks

• Change in subjective response to cannabis

  5 weeks

• Change in state anxiety across conditions

  5 weeks

• Change in psychological distress across conditions

  5 weeks

Study Arms (3)

Cannabis oil with a high ratio of THC to CBD

ACTIVE COMPARATOR

Participants will be given a single dose of oral cannabis oil containing 5mg THC and 0.17mg CBD.

Drug: Cannabis oil with a high ratio of THC to CBD

Cannabis oil with a high ratio of CBD to THC

ACTIVE COMPARATOR

Participants will be given a single dose of oral cannabis oil containing 5mg THC and 25mg CBD.

Drug: Cannabis oil with a high ratio of CBD to THC

Placebo

PLACEBO COMPARATOR

Participants will be given a single dose of 1 mL placebo (carrier oil with botanical terpenes) via oral route of administration.

Drug: Placebo

Interventions

Cannabis oil with a high ratio of THC to CBD DRUG

In the first active condition, cannabis oil with a high THC to CBD ratio will be administered to participants.

Cannabis oil with a high ratio of THC to CBD

Cannabis oil with a high ratio of CBD to THC DRUG

In the second active condition, cannabis oil with a high CBD to THC ratio will be administered to participants.

Cannabis oil with a high ratio of CBD to THC

Placebo DRUG

In the control condition, the placebo will be administered to participants.

Placebo

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are 19-35 years old at the start of the study
• Have used oral cannabis, including at least 5mg of THC, at least once in their life
• Have used cannabis at least once in the past year
• Used cannabis less than 3 times per week on average, in the past 3 months
• Are using an effective and/or highly effective method of contraception and will continue to do so for the duration of participation in the study. Health Canada's definition of effective methods of contraception include barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge). Health Canada's definition of highly effective methods of contraception includes hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation.
• Females: are not undergoing alternative fertility methods, such as IVF, or otherwise trying to start a family for the duration of participation
• Males: will not be donating sperm at some point during the duration of participation
• Are able to provide informed consent
• Are able to complete assessments in English
• Are able to attend sessions according to the study schedule
• Will provide proof of 2 doses of an approved COVID-19 vaccination

You may not qualify if:

• Are left-handed or ambidextrous
• Females: are pregnant, nursing, or not on safe pregnancy protection
• Are trying to conceive
• Have a known or suspected allergy to cannabinoids and/or palm/coconut oil
• 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 had an adverse reaction (unwanted, unexpected reaction or symptoms) to cannabis within last 6 months
• 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)
• Are taking any of the following medications:

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

B.R.A.I.N. Lab, Institute of Mental Health, Faculty of Medicine, University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Christian G Schütz, MD PhD

  University of British Columbia; British Columbia Mental Health and Substance Use Services

  PRINCIPAL INVESTIGATOR

• Karina A Thiessen, BA BEd

  University of British Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded masking.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 2, 2022
• Study Start: October 15, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)