Health TrialsbyHealthPanel

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

ConditionCannabis Intoxication
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-55
SponsorJohns Hopkins University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Cannabis

    Drug

    Cannabis will be administered via smoked inhalation.

  • 0 mg THC (placebo)

    Other intervention

    0 mg THC (placebo)

Treatment groups

70 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Indica-Labeled Cannabis - PlaceboPlacebo comparator 2 interventions
Group B: Sativa-Labeled Cannabis - PlaceboPlacebo comparator 2 interventions
Group C: Generically-Labeled Cannabis - PlaceboPlacebo comparator 2 interventions
Group D: Indica-Labeled Cannabis - ActiveExperimental treatment 1 intervention
Group E: Sativa-Labeled Cannabis - ActiveExperimental treatment 1 intervention
Group F: Generically-Labeled Cannabis - ActiveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

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

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).

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

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).

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

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.

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

Secondary outcomes

1

Drug Effect Questionnaire - Like Drug Effect

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

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

Anticipated Effects of Cannabis Scale (AECS) - Creative

The AECS will be used to obtain subjective ratings of "creative". Score range from 0 (none) to 10 (extreme) using a 10mm line anchored with none/extreme designation.

Time frame
Baseline prior to drug administration
3

Anticipated Effects of Cannabis Scale (AECS) - Drowsy

The AECS will be used to obtain subjective ratings of "Drowsy". Score range from 0 (none) to 10 (extreme) using a 10mm line anchored with none/extreme designation.

Time frame
Baseline prior to drug administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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