Clinical trial NCT05488509: Acute Effects of Cannabis on Everyday Life Memory
Official title: Acute Effects of Cannabis on Everyday Life Memory
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cannabis Use
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 156
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind placebo-controlled clinical trial
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine the acute effects of cannabis on various aspects of memory. Eligible participants will complete a drug screen. Participants who pass the drug screen will be asked to wear an Empatica E4 wristband for the duration of the study. Participants will provide a saliva sample from which cortisol will be extracted. They will then complete baseline measures of cannabis consumption patterns, level of intoxication, mood, anxiety, stress, and verbal intelligence. Next, participants will be randomly assigned to inhale vapor from cannabis containing 20mg THC, 40mg THC, or placebo; both cannabis and placebo will be obtained from the National Institute on Drug Abuse (NIDA). Participants will then will complete a battery of memory tests including tests of prospective, verbal, visuospatial, source, verbal working, visuospatial working, false, and temporal order memory. Memory tests will be completed across two blocks in a counterbalanced order. Saliva samples will be obtained two additional times after drug/placebo administration. Ratings of intoxication, mood, anxiety, and stress will be obtained three additional times after drug/placebo administration. The investigators hypothesize that participants who are randomly assigned to inhale cannabis vapor will perform worse on all memory tests than participants who inhale the placebo.

Detailed description: This study will examine the acute effects of cannabis on various aspects of memory (prospective memory, temporal order memory, false memory, source memory, verbal memory, visuospatial memory, working memory). The investigators hypothesize that participants who are randomly assigned to inhale cannabis vapor will perform worse on all memory tests than participants who inhale a placebo product. Further, they hypothesize larger effects in the 40mg than 20mg THC condition.

Participants will meet the research assistant in The Health \& Cognition (THC) lab testing room in the Department of Psychology at Washington State University (WSU). After obtaining written informed consent participants will be asked 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 and will be rescheduled for another day. Those who report abstinence on the day of the testing session will be asked to complete a commercially available 12-panel urine drug test to ensure they test positive for cannabis/THC but no other illicit drugs. Participants who don't test positive for cannabis/THC or who do test positive for other illicit drugs are not eligible and will not be permitted to complete the study.

Participants who pass the drug test (positive for cannabis/THC and negative for other illicit drugs) will then be asked to put on an Empatica E4 medical-grade wristband that will collect continuous measures of heart rate, electrodermal activity, temperature, and motion. They will also complete baseline measures of cannabis consumption patterns, level of intoxication, mood, anxiety, stress, and verbal intelligence.

Next, the researcher will bring the participant down to a separate secluded room for the vaping session. The researcher will take the Volcano Vaporizer pre-loaded with cannabis containing 20 mg of THC, 40 mg of THC, or placebo (the research assistant \[RA\] and participant will be blind to the product - only PI Dr. McLaughlin will load the product and be unblinded) out of the locked cabinet and position it directly under the fume hood. The researcher will turn the vaporizer on and will wait until it heats up to 360 degrees Fahrenheit. Once the vaporizer is at the correct temperature the research assistant will show the participant how to operate the vaporizer. The RA will then set up a Zoom videoconferencing session on a computer positioned so that they can observe and communicate with the participant from a remote lab room during the vapor session. This Zoom session will not be recorded. The fume hood will be turned on and the participant will be instructed to wait to vape the product until the RA joins them on the Zoom call. The RA will exit the vaping room, join the Zoom call from the testing room, then instruct the participant to activate the Volcano Vaporizer and let it continue to run until the bag is completely full of vapor. They will then be instructed to stop the device, remove the bag, position the mouthpiece, and begin inhaling the vapor. They will be instructed to inhale for 5 seconds, hold the vapor in their lungs for 10 seconds and then exhale into the "sploofy" under the fume hood. They will then be asked to wait for 40 seconds before inhaling again for 5 seconds and holding for 10 seconds. This will be continued until the participant has inhaled 2 bags of vapor. The RA will count the total number of hits/puffs and bags the participant inhales.

After the vape session is complete, the RA will bring the participant back to the testing room to complete a battery of memory tests (completed across two blocks in a counterbalanced order always beginning with the prospective memory test instructions and ending with the temporal order memory test). Before the first block and at the end of each block, participants will re-rate intoxication, mood, anxiety, and stress.

Finally, participants will be debriefed. They will then sit and play video games and/or watch television (TV) or read in a separate entertainment room until it has been a total of 4 hours since their vape session ended, and they report feeling sober. RAs will collect intoxication ratings every 30 minutes. Snacks (e.g., chocolate bars, chips, gummies, granola bars, water, soda, and juice) will be provided and we will monitor the quantity and types of snacks participants consume.

Cannabis containing 11.86% THC will be obtained from the National Institute on Drug Abuse (NIDA). Nevertheless, our plan for dosing considers potency (grams of flower x 1000 x %THC = mg THC) so participants in the 20mg THC condition will be administered .17 grams of cannabis containing 11.86% THC, while those in the 40 mg condition will be administered .34 grams of cannabis containing 11.86% THC.

Eligibility criteria: Inclusion Criteria:

* Have used cannabis at least once a week for at least one year
* Willing to abstain from using any cannabis on the day of their scheduled testing session (minimum of 8 hours of abstinence)

Exclusion Criteria:

* Diagnosis of a serious psychiatric condition (psychosis, bipolar I, panic disorder)
* Family history of psychosis
* Diagnosis of a neurological disorder
* Diagnosis of a chronic medical condition (e.g., heart disease, diabetes)
* Diagnosis of a learning disability
* History of multiple concussions
* History of head injury that may impact cognition
* Being pregnant
* Lactating
* History of adverse experiences with cannabis (anxiety, panic attacks)
* Use of illicit drugs in the past 6 months
* Heavy alcohol use (\>4 drinks, \>4 times/week)
* Smoking/nicotine use
* BMI greater than 34

Primary outcomes:
measure: Difficulties Rating Prospective Memory Test
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Bell Ring Prospective Memory Test
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Immediate Verbal Memory
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Delayed Verbal Memory
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Immediate Visuospatial Memory
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Delayed Visuospatial Memory
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Source Memory Test - Free Recall
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Source Memory - Recognition
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Verbal Working Memory - Digit Span Forward
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Verbal Working Memory - Digit Span Backward
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Visuospatial Working Memory - Block Span
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Visuospatial Working Memory - Total Score
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: False Memory Test - Free Recall
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: False Recognition Memory for Critical Lures
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: False Recognition Memory for Related Words
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: False Recognition Memory for Unrelated Words
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Temporal Order Memory Recall
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
measure: Temporal Order Memory Recognition
timeFrame: This outcome will be assessed during the testing session, within 90 min post-treatment.
Secondary outcomes:
measure: Baseline Intoxication Rating
timeFrame: This outcome will be assessed at baseline (i.e., during the testing session but before treatment).
measure: Post-treatment Intoxication Rating
timeFrame: This outcome will be assessed during the testing session, immediately after treatment.
measure: Mid-testing Intoxication Rating
timeFrame: This outcome will be assessed during the midpoint of the testing session.
measure: Post-testing Intoxication Rating 1
timeFrame: This outcome will be assessed at the end of the testing session.
measure: Post-testing Intoxication Rating 2
timeFrame: This outcome will be assessed 30 minutes after the end of the testing session.
measure: Post-testing Intoxication Rating 3
timeFrame: This outcome will be assessed 60 minutes after the end of the testing session.
measure: Post-testing Intoxication Rating 4
timeFrame: This outcome will be assessed 90 minutes after the end of the testing session.
measure: Post-testing Intoxication Rating 5
timeFrame: This outcome will be assessed 120 minutes after the end of the testing session.
measure: Post-testing Intoxication Rating 6
timeFrame: This outcome will be assessed 2.5 hours after the end of the testing session.
measure: Post-testing Intoxication Rating 7
timeFrame: This outcome will be assessed 3 hours after the end of the testing session.
measure: Mood Rating Change Score (Baseline to Post-treatment)
timeFrame: This outcome will be computed from measures collected at baseline (i.e., during the testing session but before treatment) and immediately after treatment.
measure: Mood Rating Change Score (Baseline to Mid-testing)
timeFrame: This outcome will be computed from measures collected at baseline (i.e., during the testing session but before treatment) and at the midpoint of testing (i.e., when the first block of testing is complete).
measure: Mood Rating Change Score (Baseline to Post-testing)
timeFrame: This outcome will be computed from measures collected at baseline (i.e., during the testing session but before treatment) and at the end of the testing session (i.e., after memory tests are complete).
measure: Stress Rating Change Score (Baseline to Post-treatment)
timeFrame: This outcome will be computed from measures collected at baseline (i.e., during the testing session but before treatment) and immediately after treatment.
measure: Stress Rating Change Score (Baseline to Mid-testing)
timeFrame: This outcome will be computed from measures collected at baseline (i.e., during the testing session but before treatment) and at the midpoint of testing (i.e., after the first block of tests are complete).
measure: Stress Rating Change Score (Baseline to Post-testing)
timeFrame: This outcome will be computed from measures collected at baseline (i.e., during the testing session but before treatment) and at the end of the testing session (i.e., after memory tests are complete).
measure: Anxiety Rating Change Score (Baseline to Post-treatment)
timeFrame: This outcome will be computed from measures collected at baseline (i.e., during the testing session but before treatment) and immediately after treatment.
measure: Anxiety Rating Change Score (Baseline to Mid-testing)
timeFrame: This outcome will be computed from measures collected at baseline (i.e., during the testing session but before treatment) and at the midpoint of testing (i.e., after the first block of tests are complete).
measure: Anxiety Rating Change Score (Baseline to Post-testing)
timeFrame: This outcome will be computed from measures collected at baseline (i.e., during the testing session but before treatment) and at the end of the testing session (i.e., after memory tests are complete).
measure: Cortisol Change Score (Baseline to Post-treatment)
timeFrame: This outcome will be computed from measures collected at baseline (i.e., during the testing session but before treatment) and immediately after treatment.
measure: Cortisol Change Score (Baseline to Post-testing)
timeFrame: This outcome will be computed from measures collected at baseline (i.e., during the testing session but before treatment) and at the end of the testing session (i.e., after memory tests are complete).
measure: Snack Consumption Type
timeFrame: This outcome will be assessed after the end of the testing session (from approximately 1-4 hours after drug/placebo administration).
measure: Snack Consumption Quantity
timeFrame: This outcome will be assessed after the end of the testing session (from approximately 1-4 hours after drug/placebo administration).
Other outcomes:
measure: Verbal Intelligence (IQ)
timeFrame: This outcome will be assessed at baseline (i.e., during the testing session but before treatment).
measure: Cannabis Consumption Patterns
timeFrame: This outcome will be assessed at baseline (i.e., during the testing session but before treatment).
measure: Drug Screen
timeFrame: This outcome will be assessed at baseline (i.e., during the testing session but before treatment).
measure: Electrodermal Activity
timeFrame: This outcome will be continuously assessed from before drug/placebo administration to immediately before they leave the lab (approximately 5 hours).
measure: Heart Rate/Heart Rate Variability
timeFrame: This outcome will be continuously assessed from before drug/placebo administration to immediately before they leave the lab (approximately 5 hours).
measure: Temperature
timeFrame: This outcome will be continuously assessed from before drug/placebo administration to immediately before they leave the lab (approximately 5 hours).
measure: Motion
timeFrame: This outcome will be continuously assessed from before drug/placebo administration to immediately before they leave the lab (approximately 5 hours).
Locations:
city: Pullman
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: Washington State University
name: Ryan McLaughlin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington State University
name: Carrie Cuttler
role: PRINCIPAL_INVESTIGATOR
References: