NCT05488509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

August 21, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

July 27, 2022

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (18)

  • Difficulties Rating Prospective Memory Test

    Participants will be asked to remember to rate how difficult they found each test immediately after it is completed, using a 0 (not at all difficult) to 10 (extremely difficult) scale. The percentage of tests they remember to provide difficulty ratings for will be computed as the outcome of interest.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Bell Ring Prospective Memory Test

    Participants will be asked to try to remember to ring a desktop bell every 15 minutes during testing. A clock will be positioned on the table for them to refer to the time. The percentage of times they remembered to ring the bell after a 15 minute interval will be computed as the outcome of interest.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Immediate Verbal Memory

    Immediate verbal memory will be assessed using the immediate trials of the California Verbal Learning Test. For these trials, participants are read a list of 16 words and are asked to immediately recall the words three times in a row. The primary outcome of interest is the average number of words correctly recalled across the three immediate memory trials.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Delayed Verbal Memory

    Delayed verbal memory will be assessed using the long delay trial of the California Verbal Learning Test. For this trial, after a delay participants must recall as many words from the list of 16 words that was previously read to them during the immediate verbal memory trials. The primary outcome of interest is the number of words correctly recalled.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Immediate Visuospatial Memory

    Immediate visuospatial memory will be assessed using the immediate trials of the Brief Visuospatial Memory Test. For these trials, participants are shown a page with 6 geometric figures for 10 seconds. The figures are then removed from the participant's sight, and they are asked to draw as many of the figures as possible in their correct location. This is repeated once. The primary outcome of interest is the average accuracy score for the two trials, which can range from 0 to 12, with higher scores indicating better immediate visuospatial memory.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Delayed Visuospatial Memory

    Delayed visuospatial memory will be assessed using the delayed trial of the Brief Visuospatial Memory Test. For this trial, after a delay, participants must draw from memory the 6 geometric figures that they were previously shown during the immediate visuospatial memory trials. They will be asked to draw as many of the figures as possible in their correct location. The primary outcome of interest is the accuracy score, which can range from 0 to 12, with higher scores indicating better delayed visuospatial memory.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Source Memory Test - Free Recall

    Participants will be shown a list of basic words and pictures (e.g., book, swing). They will be told to read each word and name each picture. Participants will later be asked to recall as many words from the list as possible. The primary outcome of interest is the number of correctly recalled words.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Source Memory - Recognition

    Participants will be shown a list of basic words and pictures (e.g., book, swing). They will be told to read each word and name each picture. Participants will later complete a source memory recognition test which will require them to identify new items (words/pictures not shown to them), old words (words/pictures shown to them) and the source of each of the words identified as old (word or picture). The primary outcome of interest is the number of words identified as old for which the correct source judgement was made.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Verbal Working Memory - Digit Span Forward

    Verbal working memory will be assessed using the Forward portion of the Digit Span Test. For this test, participants are read lists of digits (of increasing lengths) and are asked to recall them in the same order. The primary outcome of interest is the total number of correct trials.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Verbal Working Memory - Digit Span Backward

    Verbal working memory will be assessed using the Backwards portion of the Digit Span Test. For this test, participants are read lists of digits (of increasing lengths) and are asked to recall them in reverse order. The primary outcome of interest is the total number of correct trials.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Visuospatial Working Memory - Block Span

    Visuospatial working memory will be assessed using the Corsi Block Tapping Test. An array of 9 blocks is positioned in front of the participant and the experimenter taps the blocks in a specific sequence and then asks the participant to tap the same blocks in the same order. This is repeated multiple times with different length sequences (3 blocks, 4 blocks, 5 blocks, and so on). The block span outcome will be calculated by determining the number of blocks in the longest sequence that the participant correctly repeated. The range of possible scores for this outcome range from 3 to 9, with larger block spans indicating better visuospatial working memory.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Visuospatial Working Memory - Total Score

    Visuospatial working memory will be assessed using the Corsi Block Tapping Test. An array of 9 blocks is positioned in front of the participant and the experimenter taps the blocks in a specific sequence and then asks the participant to tap the same blocks in the same order. This is repeated multiple times with different length sequences (3 blocks, 4 blocks, 5 blocks, and so on). The total score outcome will be calculated by counting the total number of sequences that were correctly repeated. The range of possible scores for this outcome range from 0 to 7, with higher scores indicating better visuospatial working memory.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • False Memory Test - Free Recall

    The immediate free recall trials of the Deese-Roediger-McDermott paradigm for false memory will administered. Participants will be read 5 lists of words. Each list will contain 15 words that all relate to one critical lure that is not included in the list (e.g., tired, bed, pillow, night, dream - critical lure sleep is never presented). Immediately after each list is presented participants will be asked to freely recall the list. The primary outcome of interest is the number of words correctly recalled.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • False Recognition Memory for Critical Lures

    The false memory recognition test of the Deese-Roediger-McDermott paradigm for false memory will be used to calculate total number of falsely recognized critical lures. After a delay, participants will be asked to indicate whether each word from a list of words was previously presented in a list during the free recall phase of the Deese-Roediger-McDermott paradigm. The list of words will include words that were previously presented, critical lures, words not presented that are highly related to words that were presented, and unrelated distractor words. The primary outcome of interest is the number of critical lures incorrectly identified also old.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • False Recognition Memory for Related Words

    The false memory recognition test of the Deese-Roediger-McDermott paradigm for false memory will be used to calculate total number of falsely recognized related words. After a delay, participants will be asked to indicate whether each word from a list of words was previously presented in a list during the free recall phase of the Deese-Roediger-McDermott paradigm. The list of words will include words that were previously presented, critical lures, words not presented that are highly related to words that were presented, and unrelated distractor words.The primary outcome of interest is the number of related words incorrectly identified also old.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • False Recognition Memory for Unrelated Words

    The false memory recognition test of the Deese-Roediger-McDermott paradigm for false memory will be used to calculate total number of falsely recognized unrelated words. After a delay, participants will be asked to indicate whether each word from a list of words was previously presented in a list during the free recall phase of the Deese-Roediger-McDermott paradigm. The list of words will include words that were previously presented, critical lures, words not presented that are highly related to words that were presented, and unrelated distractor words. The primary outcome of interest is the number of unrelated words incorrectly identified also old.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Temporal Order Memory Recall

    Participants will be asked to freely recall all the tests they completed as part of the test battery in the order in which they were completed. The order of each recalled test will be scored for accuracy and summed to yield the overall accuracy score. The outcome of interest is the overall accuracy score, with higher scores indicating better temporal order memory recall.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

  • Temporal Order Memory Recognition

    Participants will be presented with cards describing each of the tests they completed, and they will be asked to organize them in the order in which the tests were administered. The order produced by the participant will be scored for accuracy against the correct order. The primary outcome of interest is the accuracy score, with higher scores indicating better temporal order memory recognition.

    This outcome will be assessed during the testing session, within 90 min post-treatment.

Secondary Outcomes (23)

  • Baseline Intoxication Rating

    This outcome will be assessed at baseline (i.e., during the testing session but before treatment).

  • Post-treatment Intoxication Rating

    This outcome will be assessed during the testing session, immediately after treatment.

  • Mid-testing Intoxication Rating

    This outcome will be assessed during the midpoint of the testing session.

  • Post-testing Intoxication Rating 1

    This outcome will be assessed at the end of the testing session.

  • Post-testing Intoxication Rating 2

    This outcome will be assessed 30 minutes after the end of the testing session.

  • +18 more secondary outcomes

Other Outcomes (7)

  • Verbal Intelligence (IQ)

    This outcome will be assessed at baseline (i.e., during the testing session but before treatment).

  • Cannabis Consumption Patterns

    This outcome will be assessed at baseline (i.e., during the testing session but before treatment).

  • Drug Screen

    This outcome will be assessed at baseline (i.e., during the testing session but before treatment).

  • +4 more other outcomes

Study Arms (3)

20mg THC

EXPERIMENTAL

Participants will inhale vapor from .17 grams of cannabis containing 11.86% THC (20mg THC total).

Drug: Cannabis

40mg THC

EXPERIMENTAL

Participants will inhale vapor from .34 grams of cannabis containing 11.86% THC (40mg THC total).

Drug: Cannabis

Placebo

PLACEBO COMPARATOR

Participants will inhale vapor from a placebo product.

Drug: Placebo

Interventions

Participants will inhale vapor from cannabis containing either 20mg THC or 40mg THC.

20mg THC40mg THC

Participants will inhale vapor from a placebo product.

Placebo

Eligibility Criteria

Age21 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington State University

Pullman, Washington, 99163, United States

Location

MeSH Terms

Interventions

nabiximols

Study Officials

  • Ryan McLaughlin, PhD

    Washington State University

    PRINCIPAL INVESTIGATOR
  • Carrie Cuttler

    Washington State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The participants and the RAs who administer the drug and the memory tests (and other outcomes) will be blinded to drug condition. The PI Dr. McLaughlin will be unblinded and will handle the drug, weigh the drug and pre-load it into the Volcano Vaporizer prior to each testing session.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Double-blind placebo-controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 27, 2022

First Posted

August 4, 2022

Study Start

August 21, 2023

Primary Completion

May 17, 2025

Study Completion

May 17, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

De-identified data will be shared upon request to the PIs after publication of our primary findings.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After the publication of primary findings
Access Criteria
Email to PI

Locations