Effects of Various Cannabis Strains on Perceptual, Subjective and Objective Use Outcomes

Phase 1Not Yet RecruitingNCT07214155

Johns Hopkins University70 enrolled

Overview

This study will evaluate the subjective and behavioral effects of cannabis products labeled as indica, sativa, or generic.

This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 6 outpatient drug administration sessions that will consist of self-administration of smoked cannabis (0, or 25mg THC) labeled as indica, sativa, or generically-labelled. Primary outcomes include performance on cognitive and psychomotor assessments, subjective drug effects, and simulated driving performance. Smoking topography will also be characterized.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Cannabis Intoxication

Interventions

CannabisDRUG

Cannabis will be administered via smoked inhalation.

0 mg THC (placebo)OTHER

0 mg THC (placebo)

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Have provided written informed consent. * Be between the ages of 21 and 55 * Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests * Test negative for drugs of abuse including breath alcohol at the screening visit and at clinic admission * Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at clinic admission. Participants must confirm use of appropriate birth control methods (e.g., condoms, birth control pills) throughout the entirety of the study. * Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg * Have prior experience smoking cannabis but not currently using more than 3 times per week on average; participants must be active cannabis users (i.e., report past 3-month use) to participate. Exclusion Criteria: * Self-reported use of illicit drugs (e.g., amphetamine, cocaine, methamphetamine, 3,4-Methylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD), ketamine, heroin, psilocybin, prescription medications not prescribed to the person) in the past 30 days. * History of or current evidence of significant medical (e.g., seizure disorder) or psychiatric illness (e.g. psychosis) judged by the investigator to put the participant at greater risk of experiencing an adverse event due to exposure or completion of other study procedures. * History of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina). * Enrolled in another clinical trial or having received any drug as part of a research study within 30 days prior to dosing. * Having previously sought medical attention to manage adverse effects following acute cannabis use * Individuals with anemia or who have donated blood in the prior 30 days

Outcomes

Primary Outcomes

Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT)

Computerized version of Paced Auditory Serial Addition Task will be administered to assess working memory performance. Will report the total correct trials out of 90 recorded (lower scores indicate worse performance).

Time frame: Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing

Driving Under the Influence of Drugs (DRUID) application global impairment score

Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).

Time frame: Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing

Number of Correct Trials on the Digit Symbol Substitution Task (DSST)

Computerized version of Digit Symbol Substitution Task will be administered to assess psychomotor performance. Will report the total correct trials in 90 seconds (lower scores indicate worse performance).

Time frame: Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing

Biphasic alcohol effects scale (BAES) - Sedative Score

The BAES is used to assess sedative and stimulant subjective effects of alcohol. It has been shown to be sensitive to the effects of cannabis too. There are 7 sedative-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall sedative score (0-70). Higher score more effects.

Time frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing

Biphasic alcohol effects scale (BAES) - Stimulant Score

The BAES is used to assess sedative and stimulant subjective effects of alcohol. It has been shown to be sensitive to the effects of cannabis too. There are 7 stimulant-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall stimulant score (0-70). Higher score more effects.

Central Contacts

Carlos A Zamarripa, PhD

CONTACT

410-550-6969 czamarr2@jhmi.edu

Data from ClinicalTrials.gov

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Effects of Various Cannabis Strains on Perceptual, Subjective and Objective Use Outcomes

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Central Contacts

Secondary Outcomes