Recruiting
Phase 1

Cannabis Products

Sponsor:

Johns Hopkins University

Code:

NCT07214155

Conditions

Cannabis Intoxication

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

Interventions

Cannabis

0 mg THC (placebo)

Study Details

Brief summary:

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

Conditions

Cannabis Intoxication

Study ID

NCT07214155

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Indica-Labeled Cannabis - Placebo

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

placebo comparator: Sativa-Labeled Cannabis - Placebo

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

placebo comparator: Generically-Labeled Cannabis - Placebo

Participants administer smoked cannabis labeled generically containing 0mg THC.

experimental: Indica-Labeled Cannabis - Active

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

experimental: Sativa-Labeled Cannabis - Active

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

experimental: Generically-Labeled Cannabis - Active

Participants administer smoked cannabis labeled generically containing 25mg THC.

Interventions

Cannabis

Cannabis will be administered via smoked inhalation.

0 mg THC (placebo)

0 mg THC (placebo)

Primary outcome measure

  • Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT) [ 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 [ 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) [ Time Frame: Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing ]
  • Biphasic alcohol effects scale (BAES) - Sedative Score [ 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 [ Time Frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing ]
  • Driving performance as assessed by standard deviation of lateral position (SDLP) [ Time Frame: Baseline, 0-, 2-, 4-, and 6-hours post dosing. ]
  • Driving performance as assessed by global drive score [ Time Frame: Baseline, 0-, 2-, 4-, and 6-hours post dosing. ]
  • Drug Effect Questionnaire (DEQ) - Feel Drug Effect [ Time Frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing ]
  • Drug Effect Questionnaire - Confidence to Drive [ Time Frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing ]
  • Drug Effect Questionnaire - Alert [ Time Frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing ]
  • Drug Effect Questionnaire - Sleepy/Tired [ Time Frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing ]

Central Contacts and Locations

Central contacts

Carlos A Zamarripa, PhD

410-550-6969czamarr2@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Carlos A Zamarripa, PhD

410-550-6969czamarr2@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 18, 2026

Last verified

Sep, 2026

Keywords

  • Cannabis
  • Indica
  • Sativa

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.