Effects of Various Cannabis Strains on Perceptual, Subjective and Objective Use Outcomes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT)
研究概览
简要总结
This study will evaluate the subjective and behavioral effects of cannabis products labeled as indica, sativa, or generic.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Indica-Labeled Cannabis - Active
Participants administer smoked cannabis labeled as indica containing 25mg THC.
干预措施: Cannabis (Drug)
Generically-Labeled Cannabis - Placebo
Participants administer smoked cannabis labeled generically containing 0mg THC.
干预措施: 0 mg THC (placebo) (Other)
Indica-Labeled Cannabis - Placebo
Participants administer smoked cannabis labeled as indica containing 0mg THC.
干预措施: 0 mg THC (placebo) (Other)
Sativa-Labeled Cannabis - Placebo
Participants administer smoked cannabis labeled as Sativa containing 0mg THC.
干预措施: 0 mg THC (placebo) (Other)
Sativa-Labeled Cannabis - Placebo
Participants administer smoked cannabis labeled as Sativa containing 0mg THC.
干预措施: Cannabis (Drug)
Sativa-Labeled Cannabis - Active
Participants administer smoked cannabis labeled as sativa containing 25mg THC.
干预措施: Cannabis (Drug)
Generically-Labeled Cannabis - Active
Participants administer smoked cannabis labeled generically containing 25mg THC.
干预措施: Cannabis (Drug)
Generically-Labeled Cannabis - Placebo
Participants administer smoked cannabis labeled generically containing 0mg THC.
干预措施: Cannabis (Drug)
Indica-Labeled Cannabis - Placebo
Participants administer smoked cannabis labeled as indica containing 0mg THC.
干预措施: Cannabis (Drug)
结局指标
主要结局
Number of Correct Trials on Paced Auditory Serial Addition Task (PASAT)
时间窗: Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
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).
Driving Under the Influence of Drugs (DRUID) application global impairment score
时间窗: Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
Acute cognitive and behavioral impairment will be assessed with global impairment score(range 0-100) on the DRUID app (higher scores indicate greater impairment).
Number of Correct Trials on the Digit Symbol Substitution Task (DSST)
时间窗: Baseline, 0-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
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).
Biphasic alcohol effects scale (BAES) - Stimulant Score
时间窗: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
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.
Biphasic alcohol effects scale (BAES) - Sedative Score
时间窗: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
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.
Driving performance as assessed by standard deviation of lateral position (SDLP)
时间窗: Baseline, 0-, 2-, 4-, and 6-hours post dosing.
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.
Driving performance as assessed by global drive score
时间窗: Baseline, 0-, 2-, 4-, and 6-hours post dosing.
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
Drug Effect Questionnaire (DEQ) - Feel Drug Effect
时间窗: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
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.
Drug Effect Questionnaire - Confidence to Drive
时间窗: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
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.
Drug Effect Questionnaire - Alert
时间窗: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
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.
Drug Effect Questionnaire - Sleepy/Tired
时间窗: Baseline, 0-, 0.5-, 1-, 1.5-, 2-, 3-, 4-, 5-, and 6-hours post-dosing
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.
次要结局
- 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)