ClinicalTrials.Veeva

Menu

Acute Effects of Cannabis on Everyday Life Memory

Washington State University logo

Washington State University

Status and phase

Enrolling
Phase 2

Conditions

Cannabis Use

Treatments

Drug: Cannabis
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05488509
19425-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

156 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

156 participants in 3 patient groups, including a placebo group

20mg THC
Experimental group
Description:
Participants will inhale vapor from .17 grams of cannabis containing 11.86% THC (20mg THC total).
Treatment:
Drug: Cannabis
40mg THC
Experimental group
Description:
Participants will inhale vapor from .34 grams of cannabis containing 11.86% THC (40mg THC total).
Treatment:
Drug: Cannabis
Placebo
Placebo Comparator group
Description:
Participants will inhale vapor from a placebo product.
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Central trial contact

Ryan McLaughlin, PhD; Carrie Cuttler, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems