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

NCT07214155 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB00529431R01DA059584
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cannabis Intoxication

Keywords

Cannabis; Indica; Sativa

Outcome Measures

Primary Outcomes (11)

• 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).

  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).

  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).

  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.

  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.

  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)

  The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions. SDLP (measured in cm) will be determined during each drive. This measure is a composite index of lateral control and incorporates lane weaving, swerving, and over-correcting. SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving. Scores range from 0 to no upper limit. Higher scores represent higher magnitude of driving impairment.

  Baseline, 0-, 2-, 4-, and 6-hours post dosing.

• Driving performance as assessed by global drive score

  Driving impairment will be assessed via a composite drive score (higher scores indicate greater impairment). The composite drive score is derived by integrating various driving outcomes (see primary and secondary driving outcomes). There is no upper or lower limit to possible scores

  Baseline, 0-, 2-, 4-, and 6-hours post dosing.

• Drug Effect Questionnaire (DEQ) - Feel Drug Effect

  The DEQ will be used to obtain subjective ratings of "feel drug effects". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.

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

• Drug Effect Questionnaire - Confidence to Drive

  The DEQ will be used to obtain subjective ratings of "confidence to drive". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.

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

• Drug Effect Questionnaire - Alert

  The DEQ will be used to obtain subjective ratings of "alert". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.

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

• Drug Effect Questionnaire - Sleepy/Tired

  The DEQ will be used to obtain subjective ratings of "sleepy/tired". Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.

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

Secondary Outcomes (3)

• Drug Effect Questionnaire - Like Drug Effect

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

• Anticipated Effects of Cannabis Scale (AECS) - Creative

  Baseline prior to drug administration

• Anticipated Effects of Cannabis Scale (AECS) - Drowsy

  Baseline prior to drug administration

Study Arms (6)

Indica-Labeled Cannabis - Placebo

PLACEBO COMPARATOR

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

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

Sativa-Labeled Cannabis - Placebo

PLACEBO COMPARATOR

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

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

Generically-Labeled Cannabis - Placebo

PLACEBO COMPARATOR

Participants administer smoked cannabis labeled generically containing 0mg THC.

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

Indica-Labeled Cannabis - Active

EXPERIMENTAL

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

Drug: Cannabis

Sativa-Labeled Cannabis - Active

EXPERIMENTAL

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

Drug: Cannabis

Generically-Labeled Cannabis - Active

EXPERIMENTAL

Participants administer smoked cannabis labeled generically containing 25mg THC.

Drug: Cannabis

Interventions

Cannabis DRUG

Cannabis will be administered via smoked inhalation.

Generically-Labeled Cannabis - Active; Generically-Labeled Cannabis - Placebo; Indica-Labeled Cannabis - Active; Indica-Labeled Cannabis - Placebo; Sativa-Labeled Cannabis - Active; Sativa-Labeled Cannabis - Placebo

0 mg THC (placebo) OTHER

0 mg THC (placebo)

Generically-Labeled Cannabis - Placebo; Indica-Labeled Cannabis - Placebo; Sativa-Labeled Cannabis - Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols; Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Carlos A Zamarripa, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos A Zamarripa, PhD

CONTACT

410-550-6969; czamarr2@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will complete all dose conditions (study arms) in a randomized order

Study Record Dates

• First Submitted: October 3, 2025
• First Posted: October 9, 2025
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share