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

NCT ID: NCT07214155

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-01

Study Completion Date

2029-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cannabis Intoxication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants will complete all dose conditions (study arms) in a randomized order
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Indica-Labeled Cannabis - Placebo

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

Group Type PLACEBO_COMPARATOR

Cannabis

Intervention Type DRUG

Cannabis will be administered via smoked inhalation.

0 mg THC (placebo)

Intervention Type OTHER

0 mg THC (placebo)

Sativa-Labeled Cannabis - Placebo

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

Group Type PLACEBO_COMPARATOR

Cannabis

Intervention Type DRUG

Cannabis will be administered via smoked inhalation.

0 mg THC (placebo)

Intervention Type OTHER

0 mg THC (placebo)

Generically-Labeled Cannabis - Placebo

Participants administer smoked cannabis labeled generically containing 0mg THC.

Group Type PLACEBO_COMPARATOR

Cannabis

Intervention Type DRUG

Cannabis will be administered via smoked inhalation.

0 mg THC (placebo)

Intervention Type OTHER

0 mg THC (placebo)

Indica-Labeled Cannabis - Active

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

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

Cannabis will be administered via smoked inhalation.

Sativa-Labeled Cannabis - Active

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

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

Cannabis will be administered via smoked inhalation.

Generically-Labeled Cannabis - Active

Participants administer smoked cannabis labeled generically containing 25mg THC.

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

Cannabis will be administered via smoked inhalation.

Interventions

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Cannabis

Cannabis will be administered via smoked inhalation.

Intervention Type DRUG

0 mg THC (placebo)

0 mg THC (placebo)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos A Zamarripa, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Central Contacts

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Carlos A Zamarripa, PhD

Role: CONTACT

410-550-6969

Other Identifiers

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R01DA059584

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00529431

Identifier Type: -

Identifier Source: org_study_id

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