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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Cannabis
  Cannabis will be administered via smoked inhalation.
• Другое 0 mg THC (placebo)
  0 mg THC (placebo)

Первичные конечные точки

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

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07214155 · IRB00529431 · R01DA059584

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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