Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2026-02-28
2028-02-29
Brief Summary
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Ninety adults who use cannabis at least weekly will be recruited from the local community. After an online screening survey, eligible participants will attend a laboratory visit where the participants will provide informed consent and complete saliva and urine drug tests to confirm recent abstinence from cannabis and absence of other drugs. Participants who pass screening will complete baseline questionnaires of cannabis use patterns, depression, anxiety, ADHD symptoms, emotion regulation, affect, and demographic information.
Cannabis and placebo materials (obtained from NIDA) will be vaporized using a Volcano vaporizer device. Participants will inhale the vapor under supervision, and neither the participant nor the researcher assessing outcomes will know which product is administered. After vaping, participants will complete repeated mood ratings, saliva samples, and a battery of cognitive tests assessing executive functions like planning, inhibition, working memory, and cognitive flexibility.
Participants will also complete a standardized stress challenge (the Maastricht Acute Stress Test), which involves repeated trials of placing their hand in cold water and doing challenging mental math, followed by additional mood ratings and saliva samples. The participants will then watch a nature video and report their feelings of awe and affect.
At the end of each session, participants will remain in a supervised room with entertainment and snacks until at least four hours have passed since vaping and the participants report feeling sober. The participants will then return for a second session with the opposite study condition (THC or placebo) one week later. Both sessions follow the same procedures. Participants are fully debriefed after completing the study.
Detailed Description
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Cannabis Procurement, Storage, and Transport: Cannabis will be obtained from the National Institute on Drug Abuse (NIDA). The investigators will obtain cannabis containing 11.86% THC (barrel #1592). Our plan for dosing considers potency (grams of flower x 1000 x %THC = mg THC), so participants in the 20 mg THC condition will be administered .17g of 11.86% THC cannabis flower. The placebo will also be obtained from NIDA.
Cannabis will be stored in the PI's secure cannabis storage facilities in the Veterinary and Biomedical Research (VBRB) building. A maximum of 24 hours before a scheduled testing session, an individual authorized by the DEA will transport a small amount of cannabis or placebo (corresponding to 20 mg THC) from the secure VBRB storage facilities to the psychology building, where participants will vape the cannabis. The product will be stored in the chamber of a Volcano Vaporizer in a locked room.
Recruitment: A total of 90 cannabis users will be recruited from Pullman and the neighboring communities. Advertisements will be placed in local cannabis dispensaries and on social media (e.g., Facebook Free \& For Sale, Reddit, Instagram). The investigators will also email chronic cannabis users who have participated in our former cannabis studies (and have indicated willingness to be contacted with invitations for subsequent studies) to invite them to participate. These advertisements and emails will include a link to an online Qualtrics survey used to determine eligibility. This survey will be used to screen for serious psychiatric conditions (psychosis, bipolar I, panic disorder), a family history of psychosis, neurological disorders, chronic medical conditions (e.g., heart disease, diabetes, Reynaud's disease), a body mass index (BMI) exceeding 34, learning disabilities, intellectual disabilities, history of multiple concussions or head injury that may impact cognition, pregnancy or lactation, and history of adverse experiences with cannabis (psychosis, panic attacks), use of illicit drugs in the past 6 months, heavy alcohol use (\>4 drinks, \>4 times/week), and smoking/nicotine use. Eligible participants will need to have used cannabis at least once a week for at least one year, the participants will need to indicate that they typically inhale cannabis, and be willing to abstain from using any cannabis on the day of their scheduled testing session (minimum of 8 hours of abstinence). This survey will be used to obtain contact information from interested and eligible candidates. Ineligible participants will not be given the opportunity to enter their contact information, so sensitive information will only be collected from anonymous individuals. Eligible candidates will be contacted using the contact information provided, and the testing session will be scheduled. Participants will be instructed not to use any cannabis on the day of the testing session (from midnight onward).
Consent \& Drug Screen: Participants will meet the research assistant in The Health \& Cognition (THC) lab in the Department of Psychology at WSU. After obtaining written informed consent, participants will be asked when they last ate and drank (anything but water) and when they last used cannabis. Participants who report using cannabis that day will be rescheduled and will be reminded that they must abstain from any cannabis use on the day of the testing session. To further verify abstinence from cannabis on the day of the testing session, the participants will be asked to complete a THC saliva test. The participants will then be asked to complete a 12-panel urine drug test to ensure the participants test negative for illicit drugs. Participants who test positive for illicit drugs are not eligible and will not be permitted to complete the study.
Survey and Baseline Assessments: Participants who pass the drug test (test negative for illicit drugs), will be asked to put on an Embrace medical-grade wristband, the research assistant (RA) will place a Muse S Athena EEG headband on them, and the participants will be asked to provide a small saliva sample (from which cortisol will be extracted) by chewing on a Salivette for 1 minute and then spitting the saturated Salivette in a sterile tube. The participants will then rate how high they feel using a scale from 0 = "not high at all" to 10 = "extremely high." Next, the participants will complete standardized, valid, and reliable measures of their cannabis consumption patterns (Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory), depression (Center for Epidemiologic Studies Depression Scale \[CES-D\]), anxiety (Beck Anxiety Inventory \[BAI\]), ADHD symptoms (Barkley Adult ADHD Rating Scale - IV), emotion regulation (Difficulties in Emotion Regulation Scale \[DERS\]), affect (Daniels Five-Factor Measure of Affective Well-Being \[D-FAW\]), and demographic information. The information from this survey will be used to characterize the sample, determine covariates that should be controlled for in analyses, and examine the potential moderating effects of depression/anxiety/emotion regulation on cannabis induced changes in mood, anxiety, and affect. Participants will then complete the Wechsler Test of Adult Reading as an index of verbal IQ.
Drug Administration: Once the baseline assessments have been obtained, the researcher will bring the participant to the vaping room for their vaping session. This is a secluded room (none of the neighboring rooms are currently in use by people) in the basement of the building with a functioning fume hood. The researcher will position the Volcano Vaporizer pre-loaded with cannabis containing 20 mg of THC or placebo (the researcher and participant will be blind to the product) near the participant. The researcher will turn the vaporizer on and will wait until it heats up to 210 degrees Celsius. This temperature is ideal as it is not hot enough for the plant material to burn, so many of the toxins associated with smoking are not released. The researcher will set up a Zoom videoconferencing session on an iPad/computer and will text one of the principal investigators (PIs) to join the Zoom call. Importantly, this Zoom session will NOT be recorded. The RA will then go to an adjacent room and wait until the cannabis session is complete to aid with their blinding to the drug condition. Once one of the PIs joins the Zoom call, the investigators will instruct the participant to begin inhaling the vapor and exhaling into a "sploofy" carbon filter. The participants will be asked to try to inhale for a minimum of 2 seconds, and hold for 2 seconds, before exhaling into the sploofy. The PI will count the total number of puffs the participant inhales and will time the duration of their inhalations and holds. Once the participant has inhaled 30 puffs, they will be asked to exhale into the air and to look to see if there is any visible vapor. If the participants see visible vapor, they will continue to take more puffs and exhale into the sploofy. Every 5-10 puffs, the participants will exhale into the air to see if they notice any vapor. This will continue until the participants don't see any vapor. The PI will ask the participant to rate how high they feel using a scale from 0 = "not high at all" to 10 = "extremely high." The participants will also rate the level of good drug effects they are experiencing and their liking of those drug effects using similar 0 to 10 scales. The PI will text the RA when the vaping session is complete, and the RA will return, clean the mouthpiece with rubbing alcohol, put the Volcano Vaporizer away, and turn on the fume hood. The RA will then bring the participant back to the original lab room to complete the cognitive tests.
Cognitive Tests: Participants will be asked to rate their affect using the D-FAW and then be asked to provide another saliva sample (from which cortisol will be extracted). Participants will be asked to complete cognitive tests of planning, inhibition, task switching, and working memory, including tests of prospective memory, the N-back, digit span backwards, tower test, zoo maps test, Stroop test, oddball task, flanker task, Wisconsin card sorting test, and verbal fluency category switching tests.
Stress Challenge: Participants will then complete the Maastricht Acute Stress Test. This test includes a physical stress challenge, a cognitive challenge, and elements of unpredictability and uncontrollability. The investigators have slightly modified the task to remove the minor deception that the participants are being video-recorded during the task. Participants will be asked to place their hand in a cooler of cold water (1-3 °C) for a predetermined yet undisclosed length of time (not to exceed 90s). Immediately after each immersion trial, participants will be instructed to complete a mental arithmetic task (counting backwards from 2043 by 17s). Each time the participants make a mistake, they will be given negative feedback and instructed to start over. Once the computer signals the start of their next hand immersion trial, the participants will stop the mental arithmetic and place their hand back in the water. The participants will continue to alternate between immersion and mental arithmetic until completing 5 immersion trials of varying duration (that never exceed 90 s) and four arithmetic trials of varying durations. Immediately before and after the stress test, the participants will provide saliva samples (from which cortisol, oxytocin, and inflammatory cytokines will be extracted), and will rate their affect using the D-FAW, and the strength of their subjective high, good drug effects and liking of the drug effects using 0 (not at all) to 10 (extremely) scales on an iPad.
Nature Video and AWE: Participants will then be brought to an adjacent room where the participants will watch a brief nature video (there are two versions of this video that will be counterbalanced). After the nature video, the participants will provide ratings of awe, their feelings of connectedness to nature, and their affect using the D-FAW. Finally, participants will be asked to rate the strength of their subjective high, good drug effects, and liking of the drug effects on an iPad. The EEG headband and Embrace wristband will then be removed.
Sobering and Debriefing: Participants will then sit and play video games and/or watch TV or read until it has been a total of 4 hours since their vape session ended, and the participants report feeling completely sober. The room is equipped with couches, chairs, a TV with streaming platforms, and a video game system. Snacks (e.g., fruit snacks, granola bars, hot pockets, uncrustables, chips, chocolate bars, nuts, jerky, soda, juice, chocolate milk, water) will also be available for participants to consume while they wait. This room is equipped with a two-way mirror, and an RA will monitor participants via the window in the adjacent room to ensure the participants do not attempt to leave the lab and to monitor and record the snacks/beverages participants choose to consume and the activities the participants choose to engage in while the participants sober up. Participants will be informed that the RA is in the adjoining room, monitoring them, and that the participants can call them for assistance at any time. The RA will enter the room every 30 minutes to collect intoxication ratings. Participants will also be asked to rate how much they enjoyed each food product or beverage they consumed in the prior 30 minutes using a 0 (dislike very much) to 10 (like very much) rating scale. Participants will be debriefed after it has been a total of 4 hours have passed since their vape session ended, and they report feeling sober (give a 0 on the intoxication rating scale).
Participants will then return for their second session, which will be identical to the first, except those administered 20 mg of THC in session 1 will be administered placebo in session 2, and those administered placebo in session 2 will be administered 20 mg of THC in session 2. Participants will be debriefed at the end of session 2.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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THC -> Placebo
Participants will inhale vapor from .17 grams of cannabis containing 11.86% THC (20mg THC total) during the first session. They will inhale vapor from a placebo product during the second session.
THC 20mg
20 mg THC delivered by vaporizing 0.17 g of 11.86% THC cannabis flower obtained from NIDA, using a Volcano vaporizer.
Placebo
Placebo obtained from NIDA and vaporized using a Volcano vaporizer.
Placebo -> THC
Participants will inhale vapor from a placebo product during the first session. They will inhale vapor from .17 grams of cannabis containing 11.86% THC (20mg THC total) during the second session.
THC 20mg
20 mg THC delivered by vaporizing 0.17 g of 11.86% THC cannabis flower obtained from NIDA, using a Volcano vaporizer.
Placebo
Placebo obtained from NIDA and vaporized using a Volcano vaporizer.
Interventions
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THC 20mg
20 mg THC delivered by vaporizing 0.17 g of 11.86% THC cannabis flower obtained from NIDA, using a Volcano vaporizer.
Placebo
Placebo obtained from NIDA and vaporized using a Volcano vaporizer.
Eligibility Criteria
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Inclusion Criteria
* be fluent in English
* use of cannabis at least once a week for at least one year
* inhalation as their typical method of administration
* be willing to abstain from cannabis on the day of their scheduled testing session
Exclusion Criteria
* serious psychiatric conditions (e.g., psychosis, bipolar disorder)
* family history of psychosis
* intellectual disabilities or learning disorders (e.g., dyslexia)
* chronic medical conditions that affect cognition or increase risk of cannabis use or exposure to cold water (e.g., heart disease, diabetes, Reynaud's disease, history of frostbite, peripheral neuropathy, history of fainting or seizures, fractures or wounds on both hands or wrists),
* heart disease
* BMI \> 34
* pregnant or lactating
* use of illicit drugs in past 6 months
* heavy use of alcohol (drinking \>4 drinks \>4 times per week)
* nicotine/tobacco use
* have experienced a severe adverse reaction to cannabis (e.g., panic attack, psychosis)
21 Years
ALL
Yes
Sponsors
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Washington State University
OTHER
Responsible Party
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Ryan Mclaughlin
Associate Professor
Principal Investigators
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Ryan J McLaughlin, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington State University
Carrie Cuttler, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington State University
Locations
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Washington State University
Pullman, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Carrie Cuttler, PhD
Role: primary
Ryan J McLaughlin, PhD
Role: backup
Other Identifiers
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25-0421
Identifier Type: -
Identifier Source: org_study_id