Clinical trial

Acute Effects of Cannabis on Everyday Life Memory

ID

Name

19425-001

Description

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 arms

Trial start

2023-08-21

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Cannabis

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

Arms:

20mg THC, 40mg THC

Placebo

Participants will inhale vapor from a placebo product.

Arms:

Placebo

Size

156

Primary endpoint

Difficulties Rating Prospective Memory Test

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

Bell Ring Prospective Memory Test

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

Immediate Verbal Memory

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

Delayed Verbal Memory

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

Immediate Visuospatial Memory

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

Delayed Visuospatial Memory

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

Source Memory Test - Free Recall

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

Source Memory - Recognition

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

Verbal Working Memory - Digit Span Forward

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

Verbal Working Memory - Digit Span Backward

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

Visuospatial Working Memory - Block Span

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

Visuospatial Working Memory - Total Score

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

False Memory Test - Free Recall

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

False Recognition Memory for Critical Lures

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

False Recognition Memory for Related Words

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

False Recognition Memory for Unrelated Words

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

Temporal Order Memory Recall

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

Temporal Order Memory Recognition

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind placebo-controlled clinical trial', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 156, 'type': 'ESTIMATED'}}

Updated at

2023-12-06

1 organization

1 product

1 drug

1 indication

Organization

Washington State University

Product

Indication

Drug