Cannabis and Polysubstance Use: Response Inhibition and Stress Exposure
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT05261321
- Lead Sponsor
- University of British Columbia
- 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.
- Detailed Description
Purpose: To examine the neurological effects of cannabis on stress reactivity and inhibition in healthy adults using recreational cannabis. This is a phase I/pilot healthy subjects trial.
Primary Hypotheses:
1. The intervention will be feasible to implement
2. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cannabis oil with a high ratio of CBD to THC 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. Placebo Placebo Participants will be given a single dose of 1 mL placebo (carrier oil with botanical terpenes) via oral route of administration. Cannabis oil with a high ratio of THC to CBD 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.
- Primary Outcome Measures
Name Time Method Change in incidence of adverse events of cannabinoids across conditions 5 weeks Assessed through self-reports from study participants (semi-structured interviews) and clinically significant adverse changes in vital signs (heart rate, blood pressure).
Change in stress response across conditions 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.
Protocol feasibility Through study completion; average of 1 year Measured via means and rates of study recruitment
Procedure feasibility Through study completion; average of 1 year Measured via means and rates of study recruitment
- Secondary Outcome Measures
Name Time Method Change in sleep quality across conditions 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 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 psychological distress across conditions 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"
Change in state anxiety across conditions 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 performance on behavioral impulsivity tasks across conditions 5 weeks Measured by Delay and Probability Discounting Procedure, Experiential Discounting Task, and the Hybrid Response Inhibition Task
Trial Locations
- Locations (1)
B.R.A.I.N. Lab, Institute of Mental Health, Faculty of Medicine, University of British Columbia
🇨🇦Vancouver, British Columbia, Canada