Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure (CAPU RISE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05261321|
Recruitment Status : Not yet recruiting
First Posted : March 2, 2022
Last Update Posted : October 19, 2022
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Cannabis oil with a high ratio of THC to CBD Drug: Cannabis oil with a high ratio of CBD to THC Drug: Placebo||Phase 1|
Purpose: To examine the neurological effects of cannabis on stress reactivity and inhibition in healthy adults using recreational cannabis weekly and drinking heavily. This is a phase I/pilot healthy subjects trial.
- The intervention will be feasible to implement
- Cannabis oil will attenuate stress, measured via biological and self-report data, including salivary molecules, functional Magnetic Resonance Imaging, and standardized psychosocial assessments.
Justification: Current cannabis research focuses on medical uses for cannabis, clinical populations and/or non-commercially available products. There remains limited experimental research on the effects of commercial products in non-clinical regular users of cannabis. Further, most drug use research excludes polysubstance users. Given the high number of people using cannabis to cope with stress, biological evidence is needed to determine the validity of this claim. Stress is known to negatively impact daily functioning and has been linked to poorer mental and physical health outcomes. The effects of cannabinoids on cognitive functioning also have implications for daily functioning.
Objectives: Determine a causal link between commercially available cannabinoid products and mechanisms involved with stress response in polysubstance users, specifically weekly cannabis users with heavy drinking (males: minimum 5 drinks, females: minimum 4 drinks on at least one occasional per month for the past 12 months). Examine the short-term effects of cannabinoids on sleep quality in this population.
Study Design: The study is a Phase I non-therapeutic pilot trial and will utilize a double-blind, placebo-controlled, within-subjects design. The acute effects of the investigational products (IPs) will be examined. Each participant will undergo an initial phone screen and 5 sessions, with sessions 2-4 involving drug administration. There will be three investigational product arms for the drug administration sessions: cannabis oil with a high ratio of THC to CBD, cannabis oil with a high ratio of CBD to THC, and placebo. Each participant will be exposed to all three arms, one per drug administration session. The order of arm will be randomized. Each drug administration session will be a minimum of10 days apart to ensure a sufficient washout period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double-blinded masking.|
|Primary Purpose:||Basic Science|
|Official Title:||Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure|
|Estimated Study Start Date :||November 2022|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
Active Comparator: Cannabis oil with a high ratio of THC to CBD
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
In the first active condition, cannabis oil with a high THC to CBD ratio will be administered to participants.
Active Comparator: Cannabis oil with a high ratio of CBD to THC
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
In the second active condition, cannabis oil with a high CBD to THC ratio will be administered to participants.
Placebo Comparator: Placebo
Participants will be given a single dose of 1 mL placebo (carrier oil with botanical terpenes) via oral route of administration.
In the control condition, the placebo will be administered to participants.
- Change in stress response across conditions [ Time Frame: 5 weeks ]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.
- Change in incidence of adverse events of cannabinoids across conditions [ Time Frame: 5 weeks ]Assessed through self-reports from study participants (semi-structured interviews) and clinically significant adverse changes in vital signs (heart rate, blood pressure).
- Procedure feasibility [ Time Frame: Through study completion; average of 1 year ]Measured via means and rates of study recruitment
- Protocol feasibility [ Time Frame: Through study completion; average of 1 year ]Measured via means and rates of study recruitment
- Change in performance on behavioral impulsivity tasks across conditions [ Time Frame: 5 weeks ]Measured by Delay and Probability Discounting Procedure, Experiential Discounting Task, and the Hybrid Response Inhibition Task
- Change in sleep quality across conditions [ Time Frame: 5 weeks ]Measured via wrist-worn actigraphy using the Fatigue Science Readiband and self-report based on the Pittsburgh Sleep Inventory
- Change in subjective response to cannabis [ Time Frame: 5 weeks ]Measured via Drug Effects Questionnaire, assessing aspects of subjective response on a scale from "Not at All" to "Extremely", "Dislike Very Much" to "Like Very Much", and other variations.
- Change in state anxiety across conditions [ Time Frame: 5 weeks ]Measured by State Anxiety sub-scale of the State Trait Anxiety sub-scale, rating experience from "Not at All" to "Very Much"
- Change in psychological distress across conditions [ Time Frame: 5 weeks ]Measured by the standardized Short Form of the Profile of Mood States, assessing experience of various feelings from "Not at All" to "Extremely"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05261321
|Contact: Christian G Schütz, MD PhDemail@example.com|
|Contact: Karina A Thiessen, BA BEdfirstname.lastname@example.org|
|Canada, British Columbia|
|B.R.A.I.N. Lab, Institute of Mental Health, Faculty of Medicine, University of British Columbia|
|Vancouver, British Columbia, Canada, V6T 1Z3|
|Contact: Christian G Schütz, MD PhD 778-873-4785 email@example.com|
|Contact: Karina A Thiessen, BA BEd 6042400051 firstname.lastname@example.org|
|Principal Investigator:||Christian G Schütz, MD PhD||University of British Columbia; British Columbia Mental Health and Substance Use Services|
|Study Director:||Karina A Thiessen, BA BEd||University of British Columbia|