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

Johns Hopkins University

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: Cannabis Intoxication

Treatments: Other: 0 mg THC (placebo); Drug: Cannabis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07214155

IRB00529431

R01DA059584 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

70 participants in 6 patient groups, including a placebo group

Indica-Labeled Cannabis - Placebo

Placebo Comparator group

Description:

Participants administer smoked cannabis labeled as indica containing 0mg THC.

Treatment:

Drug: Cannabis

Other: 0 mg THC (placebo)

Sativa-Labeled Cannabis - Placebo

Placebo Comparator group

Description:

Participants administer smoked cannabis labeled as Sativa containing 0mg THC.

Treatment:

Drug: Cannabis

Other: 0 mg THC (placebo)

Generically-Labeled Cannabis - Placebo

Placebo Comparator group

Description:

Participants administer smoked cannabis labeled generically containing 0mg THC.

Treatment:

Drug: Cannabis

Other: 0 mg THC (placebo)

Indica-Labeled Cannabis - Active

Experimental group

Description:

Participants administer smoked cannabis labeled as indica containing 25mg THC.

Treatment:

Drug: Cannabis

Sativa-Labeled Cannabis - Active

Experimental group

Description:

Participants administer smoked cannabis labeled as sativa containing 25mg THC.

Treatment:

Drug: Cannabis

Generically-Labeled Cannabis - Active

Experimental group

Description:

Participants administer smoked cannabis labeled generically containing 25mg THC.

Treatment:

Drug: Cannabis