Menu
Not yet recruiting NCT07214155

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

Phase I Interventional Cannabis Intoxication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cannabis, 0 mg THC (placebo).
Who it may be relevant to
Registry conditions: Cannabis Intoxication. Basic parameters: 21 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed 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.

Interventions

  • Drug Cannabis
    Cannabis will be administered via smoked inhalation.
  • Other 0 mg THC (placebo)
    0 mg THC (placebo)

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Drug Effect Questionnaire - Like Drug Effect [Time frame: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing]
  • Anticipated Effects of Cannabis Scale (AECS) - Creative [Time frame: Baseline prior to drug administration]
  • Anticipated Effects of Cannabis Scale (AECS) - Drowsy [Time frame: Baseline prior to drug administration]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07214155 · IRB00529431 · R01DA059584

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗